A Phase 2/3 interventional study of ACT and TACT in Malaria, Falciparum, sponsored by University of Oxford. Completed at 20 sites in 8 countries. Open to participants aged 6 Months to 65 Years. Per ClinicalTrials.gov, last updated 2018-05-09.
Sponsored by University of Oxford · Phase 2/3, Interventional, and Treatment
This study is an open-label randomised trial comparing standard ACT treatment with matching triple artemisinin-based combination therapies (TACTs), evaluating efficacy in safety and tolerability. The estimated total sample size is 2040 patients from 16 sites in Asia and 1 site in Africa. There are 2 arm study groups that have 2 treatment arms each.
Study group A:
A.1: Artemether-lumefantrine for 3 days. versus: A.2: Artemether-lumefantrine for 3 days plus Amodiaquine for 3 days.
Study group B:
B.1: Dihydroartemisinin-piperaquine for 3 days. versus: B.2: Dihydroartemisinin-piperaquine for 3 days plus Mefloquine hydrochloride for 3 days.
Study group C:
C.1: Artesunate-mefloquine for 3 days versus: C.2: Dihydroartemisinin-piperaquine for 3 days plus Mefloquine hydrochloride for 3 days.
According to the WHO guideline, all patients except for children under the age of 1 year or a weight below 10 kilograms will also be treated with a single dose of low dose primaquine.
In Laos, Myanmar, Bangladesh, India and DRC, the following two combinations will be used:
In Myanmar and Vietnam the following two combinations will be used:
In Cambodia and Thailand the following two combinations will be used:
455 studies on the registry are indexed under Malaria, Falciparum; 37 are open to participants now.
This study's enrollment of 1,110 is above the median of 126 across 376 interventional studies indexed under Malaria, Falciparum.
Browse Malaria, Falciparum studies →University of Oxford is the lead sponsor of 812 studies on the registry; 119 are open to participants now.
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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.
Exclusion Criteria:
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.
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.
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).
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1.1 Artemether-lumefantrine for 3 days. 1.2 Dihydroartemisinin-piperaquine for 3 days 1.3 Artesunate-Mefloquine for 3 days
Drug: ACT
2.1: Artemether-lumefantrine for 3 days.plus: Amodiaquine for 3 days. 2.2: Dihydroartemisinin-piperaquine for 3 days. plus: Mefloquine hydrochloride for 3 days. 2.3 Dihydroartemisinin-piperaquine for 3 days. plus: Mefloquine hydrochloride for 3 days.
Drug: TACT
1. Artemether-lumefantrine for 3 days 2. Dihydroartemisinin-piperaquine for 3 days. 3. Artesunate-mefloquine for 3 days
1. Artemether-lumefantrine for 3 days plus Amodiaquine for 3 days. 2. Dihydroartemisinin-piperaquine for 3 days plus Mefloquine hydrochloride for 3 days. 3. Dihydroartemisinin-piperaquine for 3 days plus Mefloquine hydrochloride for 3 days.
PCR corrected efficacy defined as adequate clinical and parasitological response (ACPR)
Time frame: 42 days
Parasite clearance half-life
Parasite clearance half-life assessed by microscopy as primary parameter to de-termine parasite clearance
Time frame: 42 days
Parasite reduction rates and ratios at 24 and 48 hours assessed by microscopy
Time frame: at 24 and 48 hours
Time for parasite count to fall to 50% of initial parasite density
Time frame: 42 days
Time for parasite count to fall to 90% of initial parasite density
Time frame: 42 days
Time for parasite count to fall to 99% of initial parasite density
Time frame: 42 days
Fever clearance time
Time frame: 42 days
Incidence of adverse events and serious adverse events
Time frame: 42 days
Incidence of adverse events concerning markers of hepatic toxicity
Total billirubin, ALT, AST and Alkaline Phosphatase will be measured
Time frame: 42 days
Incidence of adverse events concerning markersof renal toxicity
Creatinine will be measured
Time frame: 42 days
Incidence of prolongation of the QTc-interval
Incidence of prolongation of the Qtc-interval above 500 ms or \> 60ms above baseline values
Time frame: 3 days
Change in hemoglobin/hematocrit
Change in hemoglobin/hematocrit on day 1 to 7, 14, 21, 28, 35 and 42 according to geographical location and study arm, stratified for G6PD status
Time frame: 42 days
Proportion of patients that reports completing a full course of observed TACT or ACT without withdrawal of consent or exclusion from study
Time frame: 42 days
Prevalence of Kelch13 mutations of known functional significance
Time frame: 42 days
Prevalence/incidence of other genetic markers of antimalarial drug resistance
Time frame: 42 days
Genome wide association with in vivo/in vitro sensitivity parasite phenotype
Time frame: 42 days
Correlation between SNPs measured in dry blood spots and whole genome sequencing in leukocyte depleted blood samples
Time frame: 42 days
Transcriptomic patterns at t=0 and t=6h comparing sensitive and resistant parasites
Time frame: 6hrs after start of treatment
Correlation between qPCR based versus microscopy based assessments of parasite clearance dynamics
Time frame: 14 days
Proportion of patients with gametocytemia before,after treatment with Primaquine
Time frame: assessed at admission, up to day 14
Levels of RNA transcription coding for male or female specific gametocytes
Time frame: at admission up to day 14
In vitro sensitivity (expressed in IC50 values among others) of P. falciparum to artemisinins and partner drugs
Time frame: 42 days
• Pharmacokinetic profiles and interactions of artemisinin-derivatives and partner drugs (half-life, Cmax, AUC, Tmax) in 20 ACT treated and 20 TACT treated patients of both study arms
Time frame: 42 days
Day 7 drug levels of partner drugs in association with treatment efficacy and treatment arm
Time frame: Day 7
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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