CompletedNCT00297882Updated Jun 8, 2021Results posted

Artemisinin-Based Combination Therapy: Clinical Trials in Cameroon

A Phase 3 interventional study of 1. Artemether-Lumefantrine (AL) and 2. Amodiaquine-Artesunate (AQ-AS) in Malaria, sponsored by London School of Hygiene and Tropical Medicine. Completed. Open to participants aged 6 Months to 120 Months. Per ClinicalTrials.gov, last updated 2021-06-08.

Sponsored by London School of Hygiene and Tropical Medicine · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 816
Allocation: Randomized
Ages: 6 Months to 120 Months
Sex: All

Study summary

This proposal aims to evaluate the safety and efficacy of artemisinin-based anti-malaria combination drugs (ACTs) for the treatment of children aged 6-120 months in different locations in Cameroon. Randomized clinical trials will provide local data on the safety of the test drugs, and on putative marker mutations of the development of resistance to ACT. The study will involve three centers, namely, Banso (Guinea-Savannah region), Limbe(Littoral Forest), and Garoua(Sahel-Savannah). The trial will compare the efficacy and safety of Amodiaquine(AQ)-Artesunate(Art) with Coartem®(Artemether-Lumefantrine). Drug efficacy will be determined using a WHO standardized 28-day protocol. Safety will be monitored through clinical examination and biochemical and hematological indices. Molecular markers of artemisinin resistance will be investigated by molecular sequencing and comparison of parasite profiles of the PfATP6 gene in drug failure cases, . Recrudescences or re-infections will be assessed by analysis of the msp1 and msp2 genes. The impact of these combinations on generation of gametocytes will be determined from gametocyte carriage rates measured by microscopy.

Read the detailed description

Outpatients will be screened for malaria by blood film examination
Malaria-positive children will be examined by the physician for inclusion or exclusion(see below)
Informed consent will be sought from the guardians of potential patients
Patients or guardians will be interviewed and a case record form completed
Patients will be randomized into one of the two arms in the ratio 4:1 AQ/Art: CoArtem and issued a study card
Filter paper and 5ml venous blood samples will be collected
Patients will be hospitalised for three days to allow completion of therapy under observation
The patient will be asked to return on days 7, 14 and 28 for assessment of clearance or recrudescence of parasites
Patient will be examined for parasites and evaluated for early treatment failure (ETF), late treatment failure (LTF), late parasitological failure (LPF) or adequate clinical and parasitological response.(ACPR).
If a patient does not appear for follow up, a community health worker will try to trace them and will collect blood onto filter paper and a microscope slide should the patient have a temperature ≥ 37.5°C
Patients whose parents opt out of the study will be administered quinine sulphate if parasitaemic
Filter paper samples will be air dried and stored with dessicant until required.
Whole blood samples collected into citrate as anticoagulant will be processed for plasma, aliquoted into 300µl lots and stored at -70°C.
Patient information will be entered at the close of each day into laptops and collectively sent to Yaounde at the end of the first month of study and thereafter at the end of each week, along with the hard copies of the case report forms.
Analysis will be performed on the samples within three months of collection for molecular markers of resistance, genetic structure of parasites and for blood drug levels of medications used in the trial

Conditions studied

Malaria

Browse trials for

Malaria 1,299

Keywords

Efficacy
Safety
Children
Cameroon

In context

Malaria

1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.

This study's enrollment of 816 is above the median of 220 across 1,027 interventional studies indexed under Malaria.

Browse Malaria studies →

Lead sponsor

London School of Hygiene and Tropical Medicine is the lead sponsor of 296 studies on the registry; 15 are open to participants now.

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

Who can participate

Ages eligible: 6 Months to 120 Months
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

children aged 6-120 months;
axillary temperature ≥ 37.5°C and/or history of fever within past 24 hours;
P. falciparum asexual parasitemia between 1000 and 100000/µl;
ability to attend follow-up visits.

Exclusion criteria

Exclusion criteria:

co-infections;
underlying chronic disease;
severe malaria as indicated by hyperparasitemia, severe anemia (PCV 15%, Hb 5g/ml), respiratory distress, inability to drink, persistent vomiting in past 24 hours;
recent history of multiple convulsions;
jaundice;
the inability to stand or sit;
history of allergy to study drugs.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 816 participants (actual)

Study arms

Active comparator
1 Artemether-Lumefantrine (AL)
Study group 1. Subjects in this group received treatment with Artemether-Lumefantrine. Children received 2 mg/kg Artemether and 12 mg/kg Lumefrantrine with milk twice daily (or every 12 hours for 3 days.
Drug: 1. Artemether-Lumefantrine (AL)
Active comparator
2 Amodiaquine-Artesunate (AQ-AS)
Study group 2. Subjects in this group received treatment with Amodiaquine-Artesunate. Children received a co-administered combination of 30 mg/kg Amodiaquine (AQ) plus 4 mg/kg Artesunate (AS) daily for 3 days.
Drug: 2. Amodiaquine-Artesunate (AQ-AS)

Interventions

Drug1. Artemether-Lumefantrine (AL)
Artemether-Lumefantrine(Co-Artem)=Artemether, 2mg/kg x 2(12h apart) and Lumefantrine, 12mg/kgx2 (12h apart).
Also known as: CoArtem
Drug2. Amodiaquine-Artesunate (AQ-AS)
Amodiaquine-Artesunate (0H),D1(24H),D2(48H)= Artesunate 4mg/kg and Amodiaquine at 10mg/kg
Also known as: Arsucam

What researchers measure

Primary outcomes

Cure Rate on Day 28
To evaluate the safety and antimalarial efficacy of two drug combinations: Artemether-Lumefantrine (AL) and Amodiaquine-Artesunate (AQ - AS) in Camaroonian patients in Mutengene, Bangolan and Garoua
Time frame: Day 0 - 28

Secondary outcomes

Cure Rate Day 14
To evaluate antimalarial efficacy of AL and AQ-AS on day 14 post-treatment
Time frame: Day 0-14

Results

Posted Jun 8, 2021

Limitations and caveats

There were no limitations or caveats that prevented completion of the trial as planned

Participant flow

Eight hundred and sixteen children aged 6-120 months with uncomplicated falciparum malaria were studied in three ecological different regions of Cameroon - Mutengene (Littoral equatorial forest), Bangolan (Rice farming guinea-savanna) and Garoua (Guinea-savannah).

Day 14

Participant flow — Day 14
Milestone	1 Artemether-Lumefantrine	2 Amodiaquine- Artesunate
Started	204	612
Completed	192	563
Not completed	12	49
Withdrew: Lack of efficacy	12	49

Day 28

Participant flow — Day 28
Milestone	1 Artemether-Lumefantrine	2 Amodiaquine- Artesunate
Started	192	563
Completed	176	540
Not completed	16	23
Withdrew: Lost to follow-up	13	23
Withdrew: Lack of efficacy	3	0

Outcome measures

PrimaryCure Rate on Day 28

To evaluate the safety and antimalarial efficacy of two drug combinations: Artemether-Lumefantrine (AL) and Amodiaquine-Artesunate (AQ - AS) in Camaroonian patients in Mutengene, Bangolan and Garoua

Time frame:: Day 0 - 28
Reported as:: Count of participants · Participants

Cure Rate on Day 28
Participants	1 Artemether-Lumefantrine AL	2 Amodiaquine-Artesunate AQ-AS
Cure Rate on Day 28	197	603

Statistical analysis

1 Artemether-Lumefantrine AL vs 2 Amodiaquine-Artesunate AQ-AS · t-test, 2 sided · p = >0.05

SecondaryCure Rate Day 14

To evaluate antimalarial efficacy of AL and AQ-AS on day 14 post-treatment

Time frame:: Day 0-14
Reported as:: Count of participants · Participants

Cure Rate Day 14
Participants	1 Artemether-Lumefantrine	2 Amodiaquine-Artesunate
Cure Rate Day 14	192	563

Statistical analysis

1 Artemether-Lumefantrine vs 2 Amodiaquine-Artesunate · t-test, 2 sided · p = >0.05

Adverse events

Collected over 28 days following treatment.. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
1 Artemether-Lumefantine (AL)	2/204 (1%)	6/204 (2.9%)	105/204 (51.5%)
2 Amodiaquine-Artesunate (AQ-AS)	2/612 (0.3%)	3/612 (0.5%)	272/612 (44.4%)

Most frequent serious events

Most frequent serious events
Event	1 Artemether-Lumefantine (AL)	2 Amodiaquine-Artesunate (AQ-AS)
HemoglobinuriaHepatobiliary disorders	3/204	0/612
Event leading to deathInfections and infestations	2/204	2/612
Blackwater feverInfections and infestations	1/204	0/612
HepatitisHepatobiliary disorders	0/204	1/612

Most frequent other events

Most frequent other events
Event	1 Artemether-Lumefantine (AL)	2 Amodiaquine-Artesunate (AQ-AS)
LeucopeniaBlood and lymphatic system disorders	53/204	139/612
AnorexiaGastrointestinal disorders	31/204	123/612
DiarrheaGastrointestinal disorders	32/204	21/612
LymphopeniaBlood and lymphatic system disorders	29/204	93/612
Abdominal painGastrointestinal disorders	25/204	63/612
NeutropeniaBlood and lymphatic system disorders	15/204	20/612
VomitingGastrointestinal disorders	15/204	23/612
ThrombocytopeniaBlood and lymphatic system disorders	9/204	20/612
Cuteneous eruptionsSkin and subcutaneous tissue disorders	3/204	21/612
ItchingSkin and subcutaneous tissue disorders	3/204	12/612

Baseline characteristics

Age, Continuous
Age, Continuous(months)	1 Artemether-Lumefantrine	2 Amodiaquine-Artemether	Total
Mean	52.87 ± 28.4	50.77 ± 27.33	51.82 ± 27.87

Sex: Female, Male
Sex: Female, Male(Participants)	1 Artemether-Lumefantrine	2 Amodiaquine-Artemether	Total
Female	104	302	406
Male	100	310	410

Region of Enrollment
Region of Enrollment(participants)	1 Artemether-Lumefantrine	2 Amodiaquine-Artemether	Total
Cameroon	204	612	816

Study locations

No study locations are listed for this record.

References and documents

Individual participant data

Plan to share: Yes — Database available on request of Prof Wilfred Mbacham wfmbacham@yahoo.com

Supporting information: Study protocol, Sap, Icf, Csr

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00297882
Lead sponsor: London School of Hygiene and Tropical Medicine
Collaborators: University of Yaounde, Cameroon Baptist Convention Health
Responsible party: Brian Greenwood (Professor, London School of Hygiene and Tropical Medicine) — Principal investigator
First posted: Mar 1, 2006
Start date: Jul 2006
Primary completion: Apr 2009
Completion: Jul 2009
Results posted: Jun 8, 2021
Last update: Jun 8, 2021

Study contacts

Wilfred F Mbacham, ScD

principal investigator · University of Yaounde

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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