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CompletedNCT02083380Updated Mar 10, 2017Results posted

Phase II Efficacy Study of Artefenomel & Piperaquine in Adults & Children With P. Falciparum Malaria.

A Phase 2/3 interventional study of Artefenomel 800mg: piperaquine 640mg and Artefenomel 800mg: piperaquine 960mg in Uncomplicated Plasmodium Falciparum Malaria, sponsored by Medicines for Malaria Venture. Completed at 9 sites in 7 countries. Open to participants aged 6 Months to 70 Years. Per ClinicalTrials.gov, last updated 2017-03-10.

Sponsored by Medicines for Malaria Venture · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
448
Allocation
Randomized
Ages
6 Months to 70 Years
Sex
All
01

Study summary

A randomised, double-blind single-dose study to determine the efficacy, safety, tolerability and pharmacokinetics of OZ439 (artefenomel) in combination with piperaquine (PQP) in patients > 0.5 years and \<= 70 years of age with uncomplicated Plasmodium falciparum malaria in Africa and Asia (Vietnam).

Interim analyses for futility were planned. Adults and children will be included through progressive step-down in age following safety review by an independent safety monitoring board (ISMB).

If the study were to meets its efficacy objectives, this will inform dose setting for Phase III studies.

Read the detailed description

A randomised, double-blind single-dose (loose combination) study in the target patient population of children > 0.5 years and \<= 5 years of age in Africa and patients of all ages in Asia (> 0.5 years and \<= 70 years) with uncomplicated Plasmodium falciparum malaria. Patients > 5 years in Africa were also to be recruited in a safety age step down procedure. The underlying assumption was that children of 5 years or less in Africa and all ages in Asia will have a higher probability of having lower immunity and hence potentially require higher drug exposure to achieve efficacy and hence the study aimed to recruit 60-80% African children \< = 5 years and 18-36% Asian patients (defined as the target population) and approximately 10% African patients >5 years,

Three OZ439/PQP treatment arms were to be included for patients >= 35 kg (800mg OZ439 in loose combination with PQP doses of either 640, 960, 1440 mg). Doses were scaled for patients \< 35kg based on the weight to achieve similar exposures in patients >= 35kg.

The study was to test for futility and dose arms were to be dropped if the probability was >30% that PCR-adjusted ACPR at Day 28 (ACPR28) was less than 90% (the target efficacy for the study was >= 95% ACPR28). Only data from patients in Asia patients and Africa patients \< 5 years were to be included in the Interim analysis, although all patients were to be included in the final analysis. Interim analyses were to occur after recruitment of approximately 50 evaluable patients per dose cohort and thereafter approximately after every 25 patients.

In a separate process, the safety of OZ439/PQP treatment arms was to be assessed at scheduled time points by an ISMB and adults and children were included through progressive step-down in age range following safety evaluation

Following Screening and informed consent, patients were to receive study drug and were to be followed for clinical signs of malaria (parasitaemia and temperature), safety assessments and pharmacokinetics up to Day 42 following dosing (Day 63 at selected sites).

02

Conditions studied

  • Uncomplicated Plasmodium Falciparum Malaria

Keywords

  • Plasmodium falciparum malaria
  • malaria
  • OZ439
  • piperaquine
  • PQP
03

In context

Malaria, Falciparum

455 studies on the registry are indexed under Malaria, Falciparum; 37 are open to participants now.

This study's enrollment of 448 is above the median of 126 across 376 interventional studies indexed under Malaria, Falciparum.

Browse Malaria, Falciparum studies →

Lead sponsor

Medicines for Malaria Venture is the lead sponsor of 66 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male or female patient age >6 months \<70 years.
  2. Body weight >5 kg \<90 kg.

  3. Presence of mono-infection of P. falciparum with:

    1. Fever, as defined by axillary temperature ≥ 37.5°C or oral/rectal/tympanic temperature ≥ 38°C, or history of fever in the previous 24 hours (history of fever must be documented) and,
    2. Microscopically confirmed parasite infection, in range 1,000 to 100,000 asexual parasites /µL of blood.
  4. Written provided by the adult patient, or parent or legally acceptable representative (LAR) of the minor patient or by an impartial witness (if the patient or patient's LAR is illiterate), and by the medically qualified Investigator. Children will be asked to provide assent where appropriate. The age from which this will be sought will be defined by local legislation.

Exclusion criteria

Exclusion Criteria:

  1. Presence of severe malaria (according to World Health Organization (WHO) definition - WHO 2013)

  2. Anti-malarial treatment:

    1. With piperaquine -based compound, mefloquine, naphthoquine or sulphadoxine/pyrimethamine (SP) within the previous 6 weeks (after their inhibition of new infections has fallen below 50%).
    2. With amodiaquine or chloroquine within the previous 4 weeks.
    3. With quinine, halofantrine, lumefantrine-based compounds and any other anti-malarial treatment or antibiotics with anti-malarial activity (including cotrimoxazole, tetracyclines, quinolones and fluoroquinolones, and azithromycin) within the past 14 days.
    4. With any herbal products or traditional medicines, within the past 7 days.
  3. Known history or evidence of disorders such as, respiratory (including active tuberculosis), hepatic, renal, gastrointestinal, immunological, neurological (including auditory), endocrine, infectious, , psychiatric, history of convulsions or other abnormality (including head trauma).
  4. Family history of sudden death or of congenital or clinical conditions known to prolong or QTcF interval or e.g. patients with a history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or with severe cardiac disease.
  5. History of symptomatic cardiac arrhythmias or with clinically relevant bradycardia.
  6. Any predisposing cardiac conditions for arrhythmia such as severe hypertension, left ventricular hypertrophy (including hypertrophic cardiomyopathy) or congestive cardiac failure accompanied by reduced left ventricle .
  7. Electrolyte disturbances, particularly hypokalaemia, hypocalcaemia or hypomagnesaemia.

  8. Any treatment which can induce a lengthening of QT interval, such as:

    1. Antiarrhythmics (e.g. amiodarone, disopyramide, dofetilide, ibutilide, procainamide, quinidine, hydroquinidine, sotalol),
    2. Neuroleptics (e.g. phenothiazines, sertindole, sultopride, chlorpromazine, haloperidol, mesoridazine, pimozide, or thioridazine),
    3. Anti-depressive agents, certain antimicrobial agents, including agents of the following classes macrolides (e.g. erythromycin, clarithromycin), fluoroquinolones (e.g. moxifloxacin, sparfloxacin), imidazole and triazole antifungal agents, and also pentamidine and saquinavir,
    4. Certain non-sedating antihistamines (e.g. terfenadine, astemizole, mizolastine), cisapride, droperidol, domperidone, bepridil, diphemanil, probucol, levomethadyl, methadone, vinca alkaloids, arsenic trioxide.
    5. Anti-emetics with known QT prolongation potential such as domperidone
  9. Mixed Plasmodium infection
  10. Severe vomiting, defined as more than three times in the 24 hours prior to enrolment in the study or inability to tolerate oral treatment, or severe diarrhoea defined as 3 or more watery stools per day
  11. Severe malnutrition (defined for subjects aged ten years or less as the weight-for-height being below -3 standard deviation or less than 70% of median of the National Centre for Health Statistics (NCHS)/WHO normalised reference values, and for subjects aged greater than ten years, a (BMI) of less than 16 (WFP Manual, Chapter 1)).
  12. Known history of , allergic or adverse reactions to piperaquine or other aminoquinolones or to OZ439 or OZ277
  13. Known active Hepatitis A IgM (HAV-IgM), surface antigen (HBsAg) or antibody (HCV Ab).
  14. If Total is normal, exclude the patient if liver function tests (AST)/ Alanine transaminase (ALT) ≥ 2x (ULN).
  15. If Total Bilirubin is > 1 and ≤ 1.5xULN, exclude the patient if AST/ALT >1.5xULN.
  16. Total Bilirubin > 1.5XULN
  17. level below 8 g/dL.
  18. Serum creatinine levels ≥2 x ULN
  19. Female patients of child bearing potential must be neither pregnant (as demonstrated by a negative pregnancy test) nor lactating, and must be willing to take measures not to become pregnant during the study period and safety follow-up period.
  20. Have received an drug within the past 4 weeks.
  21. Previous participation in any malaria vaccine study or received malaria vaccine in any other circumstance.
Terms in these criteria, in plain language(14)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
448 participants (actual)

Study arms

  • Experimental
    A) Artefenomel 800mg: piperaquine 640mg

    One single dose of Artefenomel 800mg: Piperaquine phosphate 640mg loose combination

    Drug: Artefenomel 800mg: piperaquine 640mg

  • Experimental
    B) Artefenomel 800mg: piperaquine 960mg

    One single dose of Artefenomel 800mg: Piperaquine phosphate 960mg loose combination

    Drug: Artefenomel 800mg: piperaquine 960mg

  • Experimental
    C) Artefenomel 800mg: piperaquine 1440mg

    One single dose of Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination

    Drug: Artefenomel 800mg: piperaquine 1440mg

Interventions

06

What researchers measure

Primary outcomes

  1. PCR-adjusted ACPR at Day 28 in the PP Population (All Patients)

    Polymerase chain reaction (PCR)-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification. Per protocol population (PP). 95% Clopper-Pearson 2-sided Confidence Interval (CI) constructed around the single binomial proportion per treatment arm and total.

    Time frame: Day 28

  2. PCR-adjusted ACPR at Day 28 in the PP Population: Asia (All Ages)

    PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification. 95% Clopper-Pearson 2-sided CI constructed around the single binomial proportion per treatment arm and total.

    Time frame: Day 28

  3. PCR-adjusted ACPR at Day 28 in the PP Population: Africa (All Ages)

    PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification. 95% Clopper-Pearson 2-sided CI constructed around the single binomial proportion per treatment arm and total.

    Time frame: Day 28

  4. PCR-adjusted ACPR at Day 28 in the PP Population: Africa (> Than 5 Years)

    PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification. 95% Clopper-Pearson 2-sided CI constructed around the single binomial proportion per treatment arm and total.

    Time frame: Day 28

  5. PCR-adjusted ACPR at Day 28 in the PP Population: Africa (< = 5 Years)

    PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification. 95% Clopper-Pearson 2-sided CI constructed around the single binomial proportion per treatment arm and total.

    Time frame: Day 28

  6. PCR-adjusted ACPR at Day 28 in the PP Population: Africa (>2 to <= 5 Years)

    PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification. 95% Clopper-Pearson 2-sided CI constructed around the single binomial proportion per treatment arm and total.

    Time frame: Day 28

  7. PCR-adjusted ACPR at Day 28 in the PP Population: Africa (>= 0.5 to <= 2 Years)

    PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification. 95% Clopper-Pearson 2-sided CI constructed around the single binomial proportion per treatment arm and total.

    Time frame: Day 28

Secondary outcomes

  1. PCR - Adjusted ACPR at Day 42 in the PP Population

    PCR - adjusted adequate clinical and parasitological response at Day 42

    Time frame: Days 42

  2. PCR-adjusted ACPR at Day 63 in the PP Population

    PCR-adjusted adequate clinical and parasitological response at Day 63

    Time frame: Day 63

  3. Crude ACPR at Day 28 in the PP Population

    Crude adequate clinical and parasitological response at Day 28

    Time frame: Day 28

  4. Crude ACPR at Day 42 in the PP Population

    Crude adequate clinical and parasitological response at Day 42

    Time frame: Day 42

  5. Crude ACPR at Day 63 in the PP Population

    Crude adequate clinical and parasitological response at Day 63

    Time frame: Day 63

  6. PCR-adjusted ACPR at Day 28 in the ITT Population

    PCR-adjusted adequate clinical and parasitological response at Day 28. Intent to Treat ( ITT) population.

    Time frame: Day 28

  7. PCR-adjusted ACPR at Day 42 in the ITT Population

    PCR-adjusted adequate clinical and parasitological response at Day 42 in the ITT population

    Time frame: Day 42

  8. PCR-adjusted ACPR at Day 63 in the ITT Population

    PCR-adjusted adequate clinical and parasitological response at Day 63 in the ITT population

    Time frame: Day 63

  9. Crude ACPR at Day 28 in the ITT Population

    Crude adequate clinical and parasitological response at Day 28 in the ITT population

    Time frame: Day 28

  10. Crude ACPR at Day 42 in the ITT Population

    Crude adequate clinical and parasitological response at Day 42 in the ITT population

    Time frame: Day 42

  11. Crude ACPR at Day 63 in the ITT Population

    Crude adequate clinical and parasitological response at Day 63 in the ITT population

    Time frame: Day 63

  12. Kaplan-Meier Estimate of Recurrence

    Kaplan-Meier estimate of number of recurrent infections (either recrudescence or new infection)

    Time frame: Day 63

  13. Kaplan-Meier Estimate of Recrudescence

    Kaplan-Meier estimate of number of patients with recrudescence

    Time frame: Day 63

  14. Kaplan-Meier Estimate of New Infection Rate

    Kaplan-Meier estimate of number of patients with new infections

    Time frame: Day 63

  15. Parasite Clearance Time

    Time post dose to parasite clearance

    Time frame: 0, 6, 12, 18, 24, 30, 36, 48 and 72 hours post dose

  16. Fever Clearance Time

    Time to fever clearance (hours)

    Time frame: Day 42

  17. PRR48

    Parasite reduction ratio at 48 hours post dose

    Time frame: 0, 6, 12, 18, 24, 30, 36 and 48 hours post dose

Other outcomes

  1. Piperaquine: Cday7 Asia (All Ages)

    Piperaquine concentration at Day7 in Asian patients all ages

    Time frame: Day 7

  2. Piperaquine: Cday7 Africa (> 5 Years)

    Piperaquine concentration at Day7 in African patients \> 5 years

    Time frame: Day 7

  3. Piperaquine: Cday7 Africa (>2 to <= 5 Years)

    Piperaquine concentration at Day7 in African patients \> 2 and \<= 5years

    Time frame: Day 7

  4. Piperaquine: Cday7 Africa (>=0.5 to <= 2 Years)

    Piperaquine concentration at Day7 in African patients \>= 0.5 and \<= 2 years

    Time frame: Day 7

  5. Artefenomel Cday7 Asian Patients (All Ages)

    Artefenomel concentration on Day 7 in Asian Patients (all ages). All Treatment arms.

    Time frame: Day 7

  6. Artefenomel Cday7 African Patients (> 5 Years)

    Artefenomel concentration on Day 7 in African Patients \> 5 years. All Treatment arms.

    Time frame: Day 7

  7. Artefenomel Cday7 African Patients (>2 to <= 5 Years)

    Artefenomel concentration on Day 7 in African Patients \>2 to \<= 5 years. All Treatment arms.

    Time frame: Day 7

  8. Artefenomel Cday7 African Patients (>=0.5 to <= 2 Years)

    Artefenomel concentration on Day 7 in African Patients \>= 0.5 to \<=2 years. All Treatment arms.

    Time frame: Day 7

07

Results

Posted Jan 30, 2017

Participant flow

Randomized double blind study. Conduct was July 2014-August 2015 in Africa (Benin, Burkina Faso, Democratic Republic of Congo, Gabon, Mozambique and Uganda) and Vietnam. Following informed consent patients were recruited to the study. Patients below the age to give legal Informed Consent were consented according local customs / legal requirements.

Participant flow — Overall Study
MilestoneA) Artefenomel 800mg: Piperaquine 640mgB) Artefenomel 800mg: Piperaquine 960mgC) Artefenomel 800mg: Piperaquine 1440mg
Started148151149
Completed575665
Not completed919584
Withdrew: Lack of efficacy687964
Withdrew: Withdrawal by subject937
Withdrew: Physician decision163
Withdrew: Adverse event001
Withdrew: Lost to follow-up533
Withdrew: Other846

Outcome measures

PrimaryPCR-adjusted ACPR at Day 28 in the PP Population (All Patients)

Polymerase chain reaction (PCR)-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification. Per protocol population (PP). 95% Clopper-Pearson 2-sided Confidence Interval (CI) constructed around the single binomial proportion per treatment arm and total.

Time frame:
Day 28
Reported as:
Number · % ACPR PCR-adjusted
PCR-adjusted ACPR at Day 28 in the PP Population (All Patients)
% ACPR PCR-adjustedA) Artefenomel 800mg: Piperaquine 640mgB) Artefenomel 800mg: Piperaquine 960mgC) Artefenomel 800mg: Piperaquine 1440mg
PCR-adjusted ACPR at Day 28 in the PP Population (All Patients)70.8 (61.13 to 79.19)68.4 (59.13 to 76.66)78.6 (70.09 to 85.67)
PrimaryPCR-adjusted ACPR at Day 28 in the PP Population: Asia (All Ages)

PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification. 95% Clopper-Pearson 2-sided CI constructed around the single binomial proportion per treatment arm and total.

Time frame:
Day 28
Reported as:
Number · % ACPR PCR-adjusted
PCR-adjusted ACPR at Day 28 in the PP Population: Asia (All Ages)
% ACPR PCR-adjustedA) Artefenomel 800mg: Piperaquine 640mgB) Artefenomel 800mg: Piperaquine 960mgC) Artefenomel 800mg: Piperaquine 1440mg
PCR-adjusted ACPR at Day 28 in the PP Population: Asia (All Ages)64 (42.52 to 82.03)64 (42.52 to 82.03)70.4 (49.82 to 86.25)
PrimaryPCR-adjusted ACPR at Day 28 in the PP Population: Africa (All Ages)

PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification. 95% Clopper-Pearson 2-sided CI constructed around the single binomial proportion per treatment arm and total.

Time frame:
Day 28
Reported as:
Number · % ACPR PCR-adjusted
PCR-adjusted ACPR at Day 28 in the PP Population: Africa (All Ages)
% ACPR PCR-adjustedA) Artefenomel 800mg: Piperaquine 640mgB) Artefenomel 800mg: Piperaquine 960mgC) Artefenomel 800mg: Piperaquine 1440mg
PCR-adjusted ACPR at Day 28 in the PP Population: Africa (All Ages)72.8 (61.81 to 82.13)69.6 (59.10 to 78.73)81.1 (71.49 to 88.59)
PrimaryPCR-adjusted ACPR at Day 28 in the PP Population: Africa (> Than 5 Years)

PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification. 95% Clopper-Pearson 2-sided CI constructed around the single binomial proportion per treatment arm and total.

Time frame:
Day 28
Reported as:
Number · % ACPR PCR-adjusted
PCR-adjusted ACPR at Day 28 in the PP Population: Africa (> Than 5 Years)
% ACPR PCR-adjustedA) Artefenomel 800mg: Piperaquine 640mgB) Artefenomel 800mg: Piperaquine 960mgC) Artefenomel 800mg: Piperaquine 1440mg
PCR-adjusted ACPR at Day 28 in the PP Population: Africa (> Than 5 Years)77.8 (52.36 to 93.59)90.5 (69.62 to 98.83)89.5 (66.86 to 98.70)
PrimaryPCR-adjusted ACPR at Day 28 in the PP Population: Africa (< = 5 Years)

PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification. 95% Clopper-Pearson 2-sided CI constructed around the single binomial proportion per treatment arm and total.

Time frame:
Day 28
Reported as:
Number · % ACPR PCR-adjusted
PCR-adjusted ACPR at Day 28 in the PP Population: Africa (< = 5 Years)
% ACPR PCR-adjustedA) Artefenomel 800mg: Piperaquine 640mgB) Artefenomel 800mg: Piperaquine 960mgC) Artefenomel 800mg: Piperaquine 1440mg
PCR-adjusted ACPR at Day 28 in the PP Population: Africa (< = 5 Years)71.4 (58.65 to 82.11)63.4 (51.10 to 74.50)78.9 (67.56 to 87.67)
PrimaryPCR-adjusted ACPR at Day 28 in the PP Population: Africa (>2 to <= 5 Years)

PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification. 95% Clopper-Pearson 2-sided CI constructed around the single binomial proportion per treatment arm and total.

Time frame:
Day 28
Reported as:
Number · % ACPR PCR-adjusted
PCR-adjusted ACPR at Day 28 in the PP Population: Africa (>2 to <= 5 Years)
% ACPR PCR-adjustedA) Artefenomel 800mg: Piperaquine 640mgB) Artefenomel 800mg: Piperaquine 960mgC) Artefenomel 800mg: Piperaquine 1440mg
PCR-adjusted ACPR at Day 28 in the PP Population: Africa (>2 to <= 5 Years)75.6 (60.46 to 87.12)74.0 (59.66 to 85.37)83.6 (71.20 to 92.23)
PrimaryPCR-adjusted ACPR at Day 28 in the PP Population: Africa (>= 0.5 to <= 2 Years)

PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification. 95% Clopper-Pearson 2-sided CI constructed around the single binomial proportion per treatment arm and total.

Time frame:
Day 28
Reported as:
Number · % ACPR PCR-adjusted
PCR-adjusted ACPR at Day 28 in the PP Population: Africa (>= 0.5 to <= 2 Years)
% ACPR PCR-adjustedA) Artefenomel 800mg: Piperaquine 640mgB) Artefenomel 800mg: Piperaquine 960mgC) Artefenomel 800mg: Piperaquine 1440mg
PCR-adjusted ACPR at Day 28 in the PP Population: Africa (>= 0.5 to <= 2 Years)61.1 (35.75 to 82.70)38.1 (18.11 to 61.56)62.5 (35.43 to 84.80)
SecondaryPCR - Adjusted ACPR at Day 42 in the PP Population

PCR - adjusted adequate clinical and parasitological response at Day 42

Time frame:
Days 42
Reported as:
Number · % ACPR PCR-adjusted
PCR - Adjusted ACPR at Day 42 in the PP Population
% ACPR PCR-adjustedA) Artefenomel 800mg: Piperaquine 640mgB) Artefenomel 800mg: Piperaquine 960mgC) Artefenomel 800mg: Piperaquine 1440mg
PCR - Adjusted ACPR at Day 42 in the PP Population65.0 (54.82 to 74.27)65.7 (55.99 to 74.60)72.0 (62.13 to 80.52)
SecondaryPCR-adjusted ACPR at Day 63 in the PP Population

PCR-adjusted adequate clinical and parasitological response at Day 63

Time frame:
Day 63
Reported as:
Number · % ACPR PCR-adjusted
PCR-adjusted ACPR at Day 63 in the PP Population
% ACPR PCR-adjustedA) Artefenomel 800mg: Piperaquine 640mgB) Artefenomel 800mg: Piperaquine 960mgC) Artefenomel 800mg: Piperaquine 1440mg
PCR-adjusted ACPR at Day 63 in the PP Population57.8 (46.49 to 68.60)58.9 (48.02 to 69.16)69.0 (58.02 to 78.69)
SecondaryCrude ACPR at Day 28 in the PP Population

Crude adequate clinical and parasitological response at Day 28

Time frame:
Day 28
Reported as:
Number · % ACPR unadjusted (crude)
Crude ACPR at Day 28 in the PP Population
% ACPR unadjusted (crude)A) Artefenomel 800mg: Piperaquine 640mgB) Artefenomel 800mg: Piperaquine 960mgC) Artefenomel 800mg: Piperaquine 1440mg
Crude ACPR at Day 28 in the PP Population57.4 (48.36 to 66.03)56.6 (47.85 to 65.09)66.9 (58.23 to 74.83)
SecondaryCrude ACPR at Day 42 in the PP Population

Crude adequate clinical and parasitological response at Day 42

Time frame:
Day 42
Reported as:
Number · % ACPR unajusted (crude)
Crude ACPR at Day 42 in the PP Population
% ACPR unajusted (crude)A) Artefenomel 800mg: Piperaquine 640mgB) Artefenomel 800mg: Piperaquine 960mgC) Artefenomel 800mg: Piperaquine 1440mg
Crude ACPR at Day 42 in the PP Population48.0 (39.09 to 57.07)48.5 (39.79 to 57.29)51.5 (42.62 to 60.39)
SecondaryCrude ACPR at Day 63 in the PP Population

Crude adequate clinical and parasitological response at Day 63

Time frame:
Day 63
Reported as:
Number · % ACPR unadjusted (crude)
Crude ACPR at Day 63 in the PP Population
% ACPR unadjusted (crude)A) Artefenomel 800mg: Piperaquine 640mgB) Artefenomel 800mg: Piperaquine 960mgC) Artefenomel 800mg: Piperaquine 1440mg
Crude ACPR at Day 63 in the PP Population42.1 (32.92 to 51.71)39.3 (30.62 to 48.59)49.1 (39.74 to 58.58)
SecondaryPCR-adjusted ACPR at Day 28 in the ITT Population

PCR-adjusted adequate clinical and parasitological response at Day 28. Intent to Treat ( ITT) population.

Time frame:
Day 28
Reported as:
Number · % ACPR PCR-adjusted
PCR-adjusted ACPR at Day 28 in the ITT Population
% ACPR PCR-adjustedA) Artefenomel 800mg: Piperaquine 640mgB) Artefenomel 800mg: Piperaquine 960mgC) Artefenomel 800mg: Piperaquine 1440mg
PCR-adjusted ACPR at Day 28 in the ITT Population53.8 (45.32 to 62.21)55.4 (47.02 to 63.57)65.1 (56.75 to 72.76)
SecondaryPCR-adjusted ACPR at Day 42 in the ITT Population

PCR-adjusted adequate clinical and parasitological response at Day 42 in the ITT population

Time frame:
Day 42
Reported as:
Number · % ACPR PCR-adjusted
PCR-adjusted ACPR at Day 42 in the ITT Population
% ACPR PCR-adjustedA) Artefenomel 800mg: Piperaquine 640mgB) Artefenomel 800mg: Piperaquine 960mgC) Artefenomel 800mg: Piperaquine 1440mg
PCR-adjusted ACPR at Day 42 in the ITT Population46.9 (38.47 to 55.37)48.6 (40.36 to 56.99)50.0 (41.62 to 58.38)
SecondaryPCR-adjusted ACPR at Day 63 in the ITT Population

PCR-adjusted adequate clinical and parasitological response at Day 63 in the ITT population

Time frame:
Day 63
Reported as:
Number · % ACPR PCR-adjusted
PCR-adjusted ACPR at Day 63 in the ITT Population
% ACPR PCR-adjustedA) Artefenomel 800mg: Piperaquine 640mgB) Artefenomel 800mg: Piperaquine 960mgC) Artefenomel 800mg: Piperaquine 1440mg
PCR-adjusted ACPR at Day 63 in the ITT Population36.8 (28.67 to 45.45)38.6 (30.47 to 47.16)43.7 (35.19 to 52.50)
SecondaryCrude ACPR at Day 28 in the ITT Population

Crude adequate clinical and parasitological response at Day 28 in the ITT population

Time frame:
Day 28
Reported as:
Number · % ACPR unadjusted (crude)
Crude ACPR at Day 28 in the ITT Population
% ACPR unadjusted (crude)A) Artefenomel 800mg: Piperaquine 640mgB) Artefenomel 800mg: Piperaquine 960mgC) Artefenomel 800mg: Piperaquine 1440mg
Crude ACPR at Day 28 in the ITT Population53.1 (44.63 to 61.53)53.4 (45.01 to 61.61)63.0 (54.64 to 70.85)
SecondaryCrude ACPR at Day 42 in the ITT Population

Crude adequate clinical and parasitological response at Day 42 in the ITT population

Time frame:
Day 42
Reported as:
Number · % ACPR unadjusted (crude)
Crude ACPR at Day 42 in the ITT Population
% ACPR unadjusted (crude)A) Artefenomel 800mg: Piperaquine 640mgB) Artefenomel 800mg: Piperaquine 960mgC) Artefenomel 800mg: Piperaquine 1440mg
Crude ACPR at Day 42 in the ITT Population44.1 (35.77 to 52.59)44.6 (36.43 to 52.98)46.6 (38.29 to 55.01)
SecondaryCrude ACPR at Day 63 in the ITT Population

Crude adequate clinical and parasitological response at Day 63 in the ITT population

Time frame:
Day 63
Reported as:
Number · % ACPR unadjusted (crude)
Crude ACPR at Day 63 in the ITT Population
% ACPR unadjusted (crude)A) Artefenomel 800mg: Piperaquine 640mgB) Artefenomel 800mg: Piperaquine 960mgC) Artefenomel 800mg: Piperaquine 1440mg
Crude ACPR at Day 63 in the ITT Population36.8 (28.67 to 45.45)35.0 (27.14 to 43.51)43.0 (34.48 to 51.76)
SecondaryKaplan-Meier Estimate of Recurrence

Kaplan-Meier estimate of number of recurrent infections (either recrudescence or new infection)

Time frame:
Day 63
Reported as:
Number · % population recurring
Kaplan-Meier Estimate of Recurrence
% population recurringA) Artefenomel 800mg: Piperaquine 640mgB) Artefenomel 800mg: Piperaquine 960mgC) Artefenomel 800mg: Piperaquine 1440mg
Kaplan-Meier Estimate of Recurrence44.754.643.6
SecondaryKaplan-Meier Estimate of Recrudescence

Kaplan-Meier estimate of number of patients with recrudescence

Time frame:
Day 63
Reported as:
Number · % patients with recrudescence
Kaplan-Meier Estimate of Recrudescence
% patients with recrudescenceA) Arttefenomel 800mg: Piperaquine 640mgB) Artefenomel 800mg: Piperaquine 960mgC) Artefenomel 800mg: Piperaquine 1440mg
Kaplan-Meier Estimate of Recrudescence22.729.118.6
SecondaryKaplan-Meier Estimate of New Infection Rate

Kaplan-Meier estimate of number of patients with new infections

Time frame:
Day 63
Reported as:
Number · % population with new infection
Kaplan-Meier Estimate of New Infection Rate
% population with new infectionA) Artefenomel 800mg: Piperaquine 640mgB) Artefenomel 800mg: Piperaquine 960mgC) Artefenomel 800mg: Piperaquine 1440mg
Kaplan-Meier Estimate of New Infection Rate11.316.313.6
SecondaryParasite Clearance Time

Time post dose to parasite clearance

Time frame:
0, 6, 12, 18, 24, 30, 36, 48 and 72 hours post dose
Reported as:
Median · hours
Parasite Clearance Time
hoursA) Artefenomel 800mg: Piperaquine 640mgB) Artefenomel 800mg: Piperaquine 960mgC) Artefenomel 800mg: Piperaquine 1440mg
Parasite Clearance Time36.1 (36.0 to 36.1)36.0 (36.0 to 36.1)36.1 (36.0 to 36.1)
SecondaryFever Clearance Time

Time to fever clearance (hours)

Time frame:
Day 42
Reported as:
Median · hours
Fever Clearance Time
hoursA) Artefenomel 800mg: Piperaquine 640mgB) Artefenomel 800mg: Piperaquine 960mgC) Artefenomel 800mg: Piperaquine 1440mg
Fever Clearance Time1.0 (1.0 to 2.6)1.2 (1.0 to 2.1)1.1 (1.0 to 2.0)
SecondaryPRR48

Parasite reduction ratio at 48 hours post dose

Time frame:
0, 6, 12, 18, 24, 30, 36 and 48 hours post dose
Reported as:
Median · ratio
PRR48
ratioA) Artefenomel 800mg: Piperaquine 640mgB) Artefenomel 800mg: Piperaquine 960mgC) Artefenomel 800mg: Piperaquine 1440mg
PRR489.120 (6.900 to 12.970)9.300 (7.660 to 13.340)8.690 (6.850 to 12.260)
Other pre-specifiedPiperaquine: Cday7 Asia (All Ages)

Piperaquine concentration at Day7 in Asian patients all ages

Time frame:
Day 7
Reported as:
Geometric mean · ng/mL
Piperaquine: Cday7 Asia (All Ages)
ng/mLA) Artefenomel 800mg: Piperaquine 640mgB) Artefenomel 800mg: Piperaquine 960mgC) Artefenomel 800mg: Piperaquine 1440mg
Piperaquine: Cday7 Asia (All Ages)4.2 ± 726.9 ± 619.3 ± 78
Other pre-specifiedPiperaquine: Cday7 Africa (> 5 Years)

Piperaquine concentration at Day7 in African patients \> 5 years

Time frame:
Day 7
Reported as:
Geometric mean · ng/mL
Piperaquine: Cday7 Africa (> 5 Years)
ng/mLA) Artefenomel 800mg: Piperaquine 640mgB) Artefenomel 800mg: Piperaquine 960mgC) Artefenomel 800mg: Piperaquine 1440mg
Piperaquine: Cday7 Africa (> 5 Years)5.6 ± 1138.8 ± 10512.1 ± 103
Other pre-specifiedPiperaquine: Cday7 Africa (>2 to <= 5 Years)

Piperaquine concentration at Day7 in African patients \> 2 and \<= 5years

Time frame:
Day 7
Reported as:
Geometric mean · ng/mL
Piperaquine: Cday7 Africa (>2 to <= 5 Years)
ng/mLA) Artefenomel 800mg: Piperaquine 640mgB) Artefenomel 800mg: Piperaquine 960mgC) Artefenomel 800mg: Piperaquine 1440mg
Piperaquine: Cday7 Africa (>2 to <= 5 Years)6.3 ± 719.2 ± 8710.9 ± 92
Other pre-specifiedPiperaquine: Cday7 Africa (>=0.5 to <= 2 Years)

Piperaquine concentration at Day7 in African patients \>= 0.5 and \<= 2 years

Time frame:
Day 7
Reported as:
Geometric mean · ng/mL
Piperaquine: Cday7 Africa (>=0.5 to <= 2 Years)
ng/mLA) Artefenomel 800mg: Piperaquine 640mgB) Artefenomel 800mg: Piperaquine 960mgC) Artefenomel 800mg: Piperaquine 1440mg
Piperaquine: Cday7 Africa (>=0.5 to <= 2 Years)5.0 ± 635.9 ± 709.0 ± 94
Other pre-specifiedArtefenomel Cday7 Asian Patients (All Ages)

Artefenomel concentration on Day 7 in Asian Patients (all ages). All Treatment arms.

Time frame:
Day 7
Reported as:
Geometric mean · ng/mL
Artefenomel Cday7 Asian Patients (All Ages)
ng/mLA) Artefenomel 800mg: PQP 640mg, 960mg & 1440mg
Artefenomel Cday7 Asian Patients (All Ages)5.1 ± 95
Other pre-specifiedArtefenomel Cday7 African Patients (> 5 Years)

Artefenomel concentration on Day 7 in African Patients \> 5 years. All Treatment arms.

Time frame:
Day 7
Reported as:
Geometric mean · ng/mL
Artefenomel Cday7 African Patients (> 5 Years)
ng/mLA) Artefenomel 800mg: PQP 640mg, 960mg & 1440mg
Artefenomel Cday7 African Patients (> 5 Years)3.3 ± 141
Other pre-specifiedArtefenomel Cday7 African Patients (>2 to <= 5 Years)

Artefenomel concentration on Day 7 in African Patients \>2 to \<= 5 years. All Treatment arms.

Time frame:
Day 7
Reported as:
Geometric mean · ng/mL
Artefenomel Cday7 African Patients (>2 to <= 5 Years)
ng/mLA) Artefenomel 800mg: PQP 640mg, 960mg & 1440mg
Artefenomel Cday7 African Patients (>2 to <= 5 Years)3.3 ± 142
Other pre-specifiedArtefenomel Cday7 African Patients (>=0.5 to <= 2 Years)

Artefenomel concentration on Day 7 in African Patients \>= 0.5 to \<=2 years. All Treatment arms.

Time frame:
Day 7
Reported as:
Geometric mean · ng/mL
Artefenomel Cday7 African Patients (>=0.5 to <= 2 Years)
ng/mLA) Artefenomel 800mg: PQP 640mg, 960mg & 1440mg
Artefenomel Cday7 African Patients (>=0.5 to <= 2 Years)2.0 ± 147

Adverse events

Collected over From screening up to Day 63 post dose. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
A) Artefenomel 800mg: PQP 640mg—1/146 (0.7%)122/146 (83.6%)
B) Artefenomel 800mg: PQP 960mg—1/148 (0.7%)127/148 (85.8%)
C) Artefenomel 800mg: PQP 1440mg—2/143 (1.4%)115/143 (80.4%)
Most frequent serious events
Most frequent serious events
EventA) Artefenomel 800mg: PQP 640mgB) Artefenomel 800mg: PQP 960mgC) Artefenomel 800mg: PQP 1440mg
Transaminase elevationInvestigations0/1460/1481/143
AnemiaInvestigations0/1460/1481/143
Hemoglobin drop < 5 g/dLInvestigations1/1460/1480/143
Febrile convulsionNervous system disorders0/1461/1480/143
Most frequent other events
Showing 10 of 11
Most frequent other events
EventA) Artefenomel 800mg: PQP 640mgB) Artefenomel 800mg: PQP 960mgC) Artefenomel 800mg: PQP 1440mg
malariaInfections and infestations34/14645/14843/143
Electrocardiumgram QT prolongedInvestigations44/14641/14827/143
DiarrhoeaGastrointestinal disorders20/14621/14811/143
Haemoglobin decreasedInvestigations11/14620/1489/143
VomitingGastrointestinal disorders16/14620/14814/143
Neutrophil count decreasedInvestigations12/14611/14818/143
BronchitisInfections and infestations10/14613/14813/143
Abdominal painGastrointestinal disorders12/1468/1485/143
PyrexiaGeneral disorders9/14612/1485/143
RhinitisInfections and infestations10/1469/14811/143

Baseline characteristics

Age, Customized
Age, Customized(participants)A) Artefenomel 800mg: PQP 640mgB) Artefenomel 800mg: PQP 960mgC) Artefenomel 800mg: PQP 1440mgTotal
> 15 years414241124
> 5 to <= 15 years88925
> 2 to <= 5 years697270211
>= 0.5 to <= 2 years25262677
Sex: Female, Male
Sex: Female, Male(Participants)A) Artefenomel 800mg: PQP 640mgB) Artefenomel 800mg: PQP 960mgC) Artefenomel 800mg: PQP 1440mgTotal
Female838598266
Male606348171
08

Study locations

9 sites
  • Centre D'Étude Et de Recherchesur Le Paludisme Associé À La Grossesse Et À L'Enfance (Cerpage) Cerpage
    Cotonou, FSS 01 BP 188, Benin
  • Centre National de Recherche et de Formation sur le paludisme (CNRFP) Ouagadougou, Kadiogo
    Ouagadougou, Burkina Faso
  • Clinical research Unit of Nanoro (CRUN)/CMA Saint Camille de Nanoro, 11 BP 218 Ouagadougou CMS 11
    Ouagadougou, Burkina Faso
  • Kinshasa School of Public Health, School of Medicine University of Kinshasa
    Kinshasa, Congo, The Democratic Republic of the
  • Centre de Recherches Medicales de Lambarene, Albert Schweitzer Hospital
    Lambarene, Gabon
  • arielle K. Bouyou-Akotet, Department of Parasitology-Mycology and Tropical Medicine, Faculty of Medicine, Université des Sciences de la Santé, BP 4009, Libreville, Gabon
    Libreville, Gabon
  • MANHIÇA HEALTH RESEARCH CENTER, Rua 12, Vila da Manhica, Maputa,
    Chefe Maputa, Mozambique
  • Tororo District Hospital
    Tororo, Uganda
  • National Institute of Malariology, Parasitology and Entomology, 245 Luong The Vinh Street, Trung van, Tu Liem, Hanoi, Vietnam
    Hanoi, Vietnam
09

References and documents

Publications

  • Leroy D, Macintyre F, Adoke Y, Ouoba S, Barry A, Mombo-Ngoma G, Ndong Ngomo JM, Varo R, Dossou Y, Tshefu AK, Duong TT, Phuc BQ, Laurijssens B, Klopper R, Khim N, Legrand E, Menard D. African isolates show a high proportion of multiple copies of the Plasmodium falciparum plasmepsin-2 gene, a piperaquine resistance marker. Malar J. 2019 Apr 10;18(1):126. doi: 10.1186/s12936-019-2756-4. PubMed 30967148 ↗
  • Macintyre F, Adoke Y, Tiono AB, Duong TT, Mombo-Ngoma G, Bouyou-Akotet M, Tinto H, Bassat Q, Issifou S, Adamy M, Demarest H, Duparc S, Leroy D, Laurijssens BE, Biguenet S, Kibuuka A, Tshefu AK, Smith M, Foster C, Leipoldt I, Kremsner PG, Phuc BQ, Ouedraogo A, Ramharter M; OZ-Piperaquine Study Group. A randomised, double-blind clinical phase II trial of the efficacy, safety, tolerability and pharmacokinetics of a single dose combination treatment with artefenomel and piperaquine in adults and children with uncomplicated Plasmodium falciparum malaria. BMC Med. 2017 Oct 9;15(1):181. doi: 10.1186/s12916-017-0940-3. PubMed 28988541 ↗

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2014, a primary completion of Oct 2015 and a completion of Nov 2015. It does not say whether these dates are actual or estimated.

Results were first posted in Jan 2017, 1 year 3 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 7, 2014
First posted
Mar 11, 2014
Start
Jul 2014
Primary completionActual
Oct 2015
CompletionActual
Nov 2015
Results first posted
Jan 30, 2017
Last update
Mar 10, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 10, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02083380
Lead sponsor
Medicines for Malaria Venture
Responsible party
Sponsor
First posted
Mar 11, 2014
Start date
Jul 2014
Primary completion
Oct 2015
Completion
Nov 2015
Results posted
Jan 30, 2017
Last update
Mar 10, 2017

Study contacts

Fiona Macintyre, PhD
study director · Medicines for Malaria Venture
Michael Ramharter, MD
principal investigator · CERMEL (Centre de Recherches Médicale de Lambaréné)

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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