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Trial no.:
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PACTR201510001189370 |
Date of Approval:
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03/07/2015 |
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Trial Status:
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Retrospective registration - This trial was registered after enrolment of the first participant |
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| TRIAL DESCRIPTION |
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Public title
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Drug therapeutic efficacy testing |
| Official scientific title |
Therapeutic efficacy of artemether-lumefantrine and artesunate-amodiaquine for the treatment of uncomplicated Plasmodium falciparum malaria in Nigerian children |
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Brief summary describing the background
and objectives of the trial
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The first Drug Therapeutic Efficacy Tests (DTET) on chloroquine and sulphadoxine-pyrimethamine were conducted between 1987 and 1999 in four sentinel sites situated in Calabar, Ibadan, Kaduna and Enugu. The most recent study of the two medicines conducted in six sentinel sites in 2002 showed a mean sensitivity of 39% and 57% for chloroquine and Sulphadoxine-pyrimethamine respectively as against the minimum of 75% recommended by WHO at that time. This abysmally high resistance demonstrated by the two medicines led to the search for immediate replacement. By 2001, the World Health Organization had recommended that all countries experiencing significant resistance to chloroquine and sulphadoxine-pyrimethamine should introduce artemisinin based combination medicines.
Between July and September 2004, efficacy trials were carried out using Artemether-Lumefantrine and Artesunate-Amodiaquine in the six Sentinel sites across the country. The outcome of this informed the adoption, in 2005, of the two medicines as the medicine of choice and the alternate medicines respectively in the country. In the past six years, over 60 million treatment courses of ACTs have been deployed to the public sector alone. With increasing use of these commodities, there is need for closer monitoring.
The primary objective is to determine the therapeutic efficacy of AL and AA in the treatment of uncomplicated Plasmodium falciparum malaria in Nigerian children aged 6¿59 months as described by the WHO protocol (2003) and using a 28-day follow-up period.
Secondary objectives include the following:
To determine the fever and parasite clearance times (where possible).
To assess gametocyte carriage before and after treatment in the study population.
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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 |
03/05/2009 |
| Actual trial start date |
03/05/2009 |
| Anticipated date of last follow up |
15/11/2010 |
| Actual Last follow-up date |
16/11/2010 |
| Anticipated target sample size (number of participants) |
0 |
| Actual target sample size (number of participants) |
747 |
| Recruitment status |
Completed |
| Publication URL |
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