Phase 3
N=816
Artemisinin-Based Combination Therapy: Clinical Trials in Cameroon
Malaria
Bottom Line
View on ClinicalTrials.gov: NCT00297882 ↗Enrolled (actual)
816
Serious AEs
1.1%
Results posted
Jun 2021
Primary outcome: Primary: Cure Rate on Day 28 — 197; 603 Participants — p=>0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 1. Artemether-Lumefantrine (AL) (Drug); 2. Amodiaquine-Artesunate (AQ-AS) (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- London School of Hygiene and Tropical Medicine
- Primary completion
- Apr 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cure Rate on Day 28 |
197; 603 | >0.05 |
| SECONDARY Cure Rate Day 14 |
192; 563 | >0.05 |
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.
Eligibility Criteria
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
- 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.
Data sourced from ClinicalTrials.gov (NCT00297882). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.