A Phase 4 interventional study of Artesunate-amodiaquine and Artemether-lumefantrine in Malaria, sponsored by Centre Muraz. Completed at 1 site in Burkina Faso. Open to participants aged 6 Months to 15 Years. Per ClinicalTrials.gov, last updated 2015-08-03.
Sponsored by Centre Muraz · Phase 4, Interventional, and Treatment
Resistance to antimalarial drugs represents a major obstacle for controlling malaria in endemic countries, so that most sub-Saharan countries have changed their antimalarial drug policy to the new Artemisinin Containing Therapies. Burkina Faso has changed its policy for uncomplicated malaria to Artemether-Lumefantrine (AL) and Artesunate-Amodiaquine (AQ+AS), but there are still little available data on safety and efficacy of these treatments in Burkina Faso; both treatments have shown to be efficacious, but AL seems to have higher occurrence of recurrent malaria infections during a 28-day follow up period. Thus, this study aims at comparing the safety and efficacy of AL and AS-AQ (42-day follow-up), AND also at comparing their in vitro sensitivity, in patients with recurrent infection, with the results obtained in vivo.
Plasmodium falciparum resistance to antimalarial drugs represents the major drawback and obstacle for controlling malaria in endemic countries; that's why most sub-Saharan countries have changed their antimalarial drug policy to Artemisinin Containing Therapies (ACT), which produce a rapid clinical and parasitological cure, reduce gametocyte carriage rate and are generally well tolerated. Burkina Faso has recently changed its policy for the treatment of uncomplicated malaria, from Chloroquine to Artemether-Lumefantrine (AL) and Artesunate-Amodiaquine (AQ+AS). However, there are still little available data on safety and efficacy of these treatments in Burkina Faso; a recent study carried out in Bobo Dioulasso showed that both treatments were extremely efficacious (adjusted treatment failure less than 5%) but with AL showing significantly high occurrence of recurrent infections during the 28-day follow up period. The higher risk for recurrent infections for AL was confirmed in a subsequent trial comparing AL with AQ-SP and dihydroartemisinin-piperaquine, but so far no direct comparison between AQ+AS and AL has been completed, though a study in Nanoro, near Ouagadougou, is ongoing. Thus, the present study aims at comparing the in vivo safety and efficacy of AL and AS-AQ (42-day follow-up),AND at comparing the in vitro sensitivity of the different ACT components, in patients with recurrent infection, with the results obtained in vivo.
1,315 studies on the registry are indexed under Malaria; 86 are open to participants now.
This study's enrollment of 440 is above the median of 220 across 1,041 interventional studies indexed under Malaria.
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Exclusion Criteria:
Treatment of malaria with Artemether-lumefantrine (AL), according to one of the two options given by national protocol in Burkina Faso
Drug: Artemether-lumefantrine
Treatment of malaria with Artesunate-amodiaquine(AS-AQ), according to one of the two options given by national protocol in Burkina Faso
Drug: Artesunate-amodiaquine
Drug pages: Artesunate · Amodiaquine
Coformulated AQ+AS by Sanofi-Aventis has been pre-qualified by WHO in 2008. It is administered once daily for three consecutive days, and it is available in three different dosages (25mg/67.5mg; 50mg/135mg; 100mg/270mg)
Also known as: ASAQ, Coarsucam
Artemether-lumefantrine by Novartis was the first fixed-dose ACT that was prequalified by WHO in April 2004. A 3-day, 6-dose regimen of AL is recommended for infants and children weighing 5-35 kg and adults weighing \> 35 kg.
Also known as: AL, Coartem(R), Riamet(R)
PCR unadjusted treatment failure (regardless of genotyping).
Time frame: 42 days
PCR adjusted treatment failure
Time frame: 42 days
PCR unadjusted treatment failure
Time frame: 28 days
PCR adjusted treatment failure
Time frame: 28 days
Fever clearance time
Time frame: day 1, 2, 3
Asexual parasite clearance time
Time frame: day 7, 14, 21, 28, 35, 42
Gametocytaemia (prevalence and density)
Time frame: Day 7, 14, 21, 28, 35 and 42
Safety profiles of the two treatments
Time frame: 42 days overall
Parasites in vitro sensitivity to the drugs tested and their relationship with the in vivo results
Time frame: before treatment and at the day of reccurrente parasitemia
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Artesunate · Amodiaquine
Centre Muraz