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ISRCTN
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ISRCTN54261005
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ClinicalTrials.gov identifier
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Public title
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Treatment of uncomplicated falciparum malaria in Bobo-Dioulasso,
Burkina Faso: comparison of amodiaquine sulfadoxine-pyrimethamine with Coartem
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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The efficacy of amodiaquine sulfadoxine pyrimethamine and artemether lumefantrine for the treatment of uncomplicated falciparum malaria in Bobo-Dioulasso, Burkina Faso will be equivalent
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Lay summary
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Ethics approval
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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
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Study design
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Randomized, single-blinded, controlled trial
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Countries of recruitment
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Burkina Faso
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Disease/condition/study domain
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Malaria
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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02/08/2005
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Anticipated end date
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22/12/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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521
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Interventions
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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.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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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
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Sources of funding
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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
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Trial website
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Publications
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http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=17292769
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Contact name
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Prof
Ouedraogo
Jean Bosco
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Address
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399 Avenue de la Liberte
P O Box 545
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City/town
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Bobo-Dioulasso
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Zip/Postcode
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01
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Country
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Burkina Faso
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Tel
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+226 20981880
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Fax
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+226 20974868
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Email
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jbouedraogo.irss@fasonet.bf
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Sponsor
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Institute of Research in Health Sciences (Institut de Recherches en Sciences de la Sante [IRSS]) (Burkina Faso)
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Address
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399 Avenue de la Liberte
P O Box 545
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City/town
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Bobo-Dioulasso
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Zip/Postcode
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01
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Country
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Burkina Faso
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Tel
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+226 20981880
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Fax
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+226 20974868
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Email
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jbouedraogo.irss@fasonet.bf
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Date applied
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24/03/2006
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Last edited
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16/02/2007
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Date ISRCTN assigned
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05/05/2006
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