Trial no.:
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PACTR201709002064150 |
Date of Approval:
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01/03/2017 |
Trial Status:
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Retrospective registration - This trial was registered after enrolment of the first participant |
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TRIAL DESCRIPTION |
Public title
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Therapeutic efficacy testing of drug |
Official scientific title |
Therapeutic Efficacy of Artemether-Lumefantrine, Artesunate-Amodiaquine, and Dihydroartemisinin Piperaquine for the Treatment of Uncomplicated Plasmodium falciparum Malaria in Nigerian Children |
Brief summary describing the background
and objectives of the trial
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The combined use of two or more antimalarial drugs with different modes of action is a recommended strategy by the World Health Organization (WHO) to improve efficacy and slow down the development and spread of resistance by the malaria parasite. The use of artemisinin derivatives in combination with antimalarials possessing longer half-lives than artemisinin drugs is thought to be effective and to prevent the development of resistance by the parasite to the individual drug. Although studies of such combinations have been carried out in African children, there is a need to monitor the efficacy of artemisinin-based combination treatments (ACTs) generally in Africa, especially with the emergence of Plasmodium falciparum insensitive parasites in southeast Asia.
In Nigeria, a recent study has shown AA and AL are effective and safe treatments of uncomplicated Plasmodium falciparum malaria in under-five year olds in all geographical areas of the country. However, the recent inclusion of dihydroartemisinin-piperaquine (DHP) as a relatively new ACT for use in falciparum malaria1 has made it imperative to evaluate the efficacy and safety of DHP in Nigerian children. The present study is designed not only to monitor the efficacy of AA and AL in falciparum malaria in under-five year olds but also to evaluate the efficacy and safety of DHP and to compare the efficacy of DHP with AA and AL.
The primary objective is to determine the therapeutic efficacy of AL, AA and DHP in the treatment of uncomplicated Plasmodium falciparum malaria in Nigerian children aged 6¿59 months.
Secondary objectives include the following:
¿ To determine fever and parasite clearance times.
¿ To evaluate gametocyte carriage before and after treatment
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Type of trial |
RCT |
Acronym (If the trial has an acronym then please provide) |
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Disease(s) or condition(s) being studied |
Infections and Infestations |
Sub-Disease(s) or condition(s) being studied |
Malaria |
Purpose of the trial |
Treatment: Other |
Anticipated trial start date |
01/07/2014 |
Actual trial start date |
01/07/2014 |
Anticipated date of last follow up |
31/12/2015 |
Actual Last follow-up date |
31/12/2015 |
Anticipated target sample size (number of participants) |
0 |
Actual target sample size (number of participants) |
992 |
Recruitment status |
Completed |
Publication URL |
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