Treatment of uncomplicated falciparum malaria in Bobo-Dioulasso, Burkina Faso: comparison of amodiaquine sulfadoxine-pyrimethamine with Coartem

ISRCTN	ISRCTN54261005
DOI	https://doi.org/10.1186/ISRCTN54261005
Protocol serial number	N/A
Sponsor	Institute of Research in Health Sciences (Institut de Recherches en Sciences de la Sante [IRSS]) (Burkina Faso)
Funders	Fogarty International Center (part of the National Institutes of Health (FIC-NIH), D43 TW01506-05 (subcontract TW/8420599), National Budget of Institut de Recherches en Sciences de la Sante (IRSS) and International Atomic Energy Agency (IAEA) RAF 6/025

Submission date: 24/03/2006
Registration date: 05/05/2006
Last edited: 16/02/2007

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Ouedraogo Jean Bosco
Scientific

399 Avenue de la Liberte
P O Box 545
Bobo-Dioulasso
01
Burkina Faso

Phone	+226 20981880
Email	jbouedraogo.irss@fasonet.bf

Study information

Primary study design	Interventional
Study design	Randomized, single-blinded, controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	The efficacy of amodiaquine sulfadoxine pyrimethamine and artemether lumefantrine for the treatment of uncomplicated falciparum malaria in Bobo-Dioulasso, Burkina Faso will be equivalent
Ethics approval(s)	Approved by the Institutional Review Board (IRB) Centre Muraz, University of California San Francisco Committee for Human Research, reference number: H2397-2758-01 and by the IRB Institute for Resource and Security Studies (IRSS), reference number: 019-2005/CE-CM
Health condition(s) or problem(s) studied	Malaria
Intervention	Subjects will be randomized to receive treatment with amodiaquine sulfadoxine pyrimethamine or artemether lumefantrine. Subjects in amodiaquine group will receive placebo to ensure the same number of doses in the two groups. Repeated therapy will be quinine.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Amodiaquine sulfadoxine pyrimethamine and artemether lumefantrine
Primary outcome measure(s)	The risk of clinical and parasitological treatment failure after 28 days of follow-up. Pairwise comparisons between regimens will be made on based on a per protocol analysis.
Key secondary outcome measure(s)	1. Risk of clinical failure after 14 days of follow-up 2. Risk of rescue therapy after 28 days of follow-up 3. Risk of fever during the first 3 days of follow-up: presence or absence of objective fever (axillary temperature >37.5 °C) or patient report of fever on days 1, 2, 3 4. Risk of parasitemia on follow-up days 2 and 3: proportion of positive versus negative thick blood smears on days 2 and 3 5. Change in mean hemoglobin from day 0 to 28 or day of repeat therapy 6. Proportion gametocytemic: presence versus absence of gametocytes on any follow-up thick blood smear; proportion gametocytemic on days 2, 3, 7, 14, 21, and 28 7. Risk of serious adverse events: proportion of patients experiencing any serious adverse event in each treatment group during the 28-day follow-up period, excluding treatment failures 8. Risk of adverse events of moderate or greater severity, at least possibly related to the study medications, excluding treatment failures
Completion date	22/12/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	521
Key inclusion criteria	1. Age ≥6 months 2. Fever (≥37.5 or history of fever in the last 24 hours) 3. Provision of informed consent 4. P. falciparum mono infection 5. Parasite density >2000 microliters and ≥200,000 microliters
Key exclusion criteria	1. Evidence of severe malaria 2. History of side effects to the investigational product 3. Pregnancy 4. Repeated vomiting of study medication on day 0 5. Hemoglobin <5 g/Dl 6. Evidence of concomitant febrile illness
Date of first enrolment	02/08/2005
Date of final enrolment	22/12/2005

Locations

Countries of recruitment

Burkina Faso

Study participating centre

399 Avenue de la Liberte

Bobo-Dioulasso
01
Burkina Faso

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Abstract results		10/02/2007		No	No