Efficacy of Artesunate-amodiaquine and Artemether-lumefantrine for Uncomplicated Malaria in South Kivu, DR Congo
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|ClinicalTrials.gov Identifier: NCT02741024|
Recruitment Status : Completed
First Posted : April 18, 2016
Last Update Posted : April 18, 2016
This will be an open-randomised non-inferiority study to test the hypothesis that the risk of recurrent parasitaemia after 42 days is not worse in the group receiving the Artesunate-Amodiaquine (ASAQ) regimen than in the group receiving the Artemether-Lumefantrine (Coartem®) regimen. Children with uncomplicated malaria meeting the inclusion criteria will be enrolled (after their parent/caretaker has given informed consent), treated on site with the drugs under evaluation and followed-up for a period of 42 days. Drugs will be given under direct supervision, either at the clinic or at home. Follow-up shall consist of a fixed schedule of clinical and laboratory examinations. Based on clinical and laboratory findings, children will be classified as therapeutic failures (early or late) or adequate responders.
The proportion of cases experiencing an in vivo therapeutic failure during the follow-up period will provide an estimate of the efficacy of the drug regimens. A Polymerase Chain Reaction (PCR) analysis will be carried out to differentiate true recrudescence due to treatment failure from episodes of re-infection. This proposal is compliant with the latest WHO recommendations for anti-malarial efficacy monitoring in high, medium or low transmission zones11.
|Condition or disease||Intervention/treatment||Phase|
|Malaria||Drug: Amodiaquine-Artesunate (ASAQ) Drug: Artemether-Lumefantrine (AL)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||288 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||In Vivo Efficacy of Artesunate-amodiaquine and Artemether-lumefantrine for the Treatment of Uncomplicated Falciparum Malaria: an Open-randomised, Non-inferiority Clinical Trial in South Kivu, DR Congo|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Active Comparator: Amodiaquine-Artesunate (ASAQ)
Treatment regimen consisted of Amodiaquine-Artesunate (ASAQ) fixed dose (FD) (Winthrop Sanofi Aventis), given as 1 tablet/day 3 days (5-8 kg 1 tab of 25mg artesunate/67.5 mg amodiaquine base, 9-17 kg 50 mg artesunate/135 mg amodiaquine base)
Drug: Amodiaquine-Artesunate (ASAQ)
Treatment on site with Amodiaquine-Artesunate according to the manufacturer's dose and instruction and follow-up for a period of 42 days. Drugs will be given under direct supervision, either at the clinic or at home
Other Name: coarsucam
Active Comparator: Artemether-Lumefantrine (AL)
Treatment consisted of Artemether-Lumefantrine (AL) (Coartem, Novartis) given as six twice/daily doses over three days (5-14 kg 1tab of 20mg artemether/120mg lumefantrine BD, 15-24 kg 2tabs of 20mg artemether/120mg lumefantrine BD with fatty food).
Drug: Artemether-Lumefantrine (AL)
Treatment on site with Artemether-lumefantrine combination according to the manufacturer's dose and instruction and follow-up for a period of 42 days.
Other Name: coartem
- Percentage of children with adequate parasitological clearance after treatment of artesunate-amodiaquine (ASAQ) and artemether-lumefantrine (AL) [ Time Frame: 42 days ]In a Kaplan Meyer survival curve it will be shown what the parasitological free period is for children treated with ASAQ or AL, uncorrected for PCR (reinfection and recrudescence) and PCR corrected (recrudescence only).
- The proportion of early therapeutic failures, late clinical failures and late parasitological failures in a period of 42 days after treatment initiation [ Time Frame: 42 days ]
- Recommendations to MoH on choice of antimalarial first line drugs [ Time Frame: 42 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02741024
|Principal Investigator:||Marit de Wit, MD, MIH||Medecins sans Frontieres, Operational Centre Amsterdam|