Evaluation of a Malaria Transmission Target Strategy Based on the Periodic Treatment With Sulfadoxine-Pyrimethamine vs. Early Case Management
Sponsor study identifier
interventional
262
1 country
1
Study Start
July 2002
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2003
Actual (reported)Study Completion
January 2004
Actual (reported)Recent, randomized controlled trials conducted in areas of perennial malaria transmission have shown that intermittent preventive treatment (IPT) given at the time of vaccination reduced the incidence of the first episode of malaria and severe anaemia during the first year of life by more than 50% without there being any rebound in the subsequent year. However, in countries such as Mali, where malaria is highly seasonal and prevalent in older children, IPT in infants may not be the optimum way in which to use antimalarial drugs to prevent malaria. An alternative approach is to give intermittent preventive treatment to children at risk just during the rainy season. Here we propose (i) to evaluate the impact of two seasonal IPT (sIPT) with Sulfadoxine-pyrimethamine (SP) given at 8 weeks interval on the incidence of malaria disease in children of 6 months to 10 years in an area of seasonal transmission, in Kambila, Mali; (ii) to assess the impact of this strategy on the in vivo response of P. falciparum to SP; (iii) to assess the potential rebound effect of this strategy on the subsequent transmission season after the cessation. Children 6 months-10 years in Kambila, Mali will randomized to receive either IPT with SP twice at 8 weeks interval or no IPT during the transmission season and will followed up for 12 months. Subjects will be also followed during the subsequent transmission season to assess possible rebound effect. Clinical malaria cases will be treated with SP and followed for 28 days to assess the in vivo response during both periods.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2004
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2002
Date type not reportedThis date has not been verified as actual or estimated.
July 2003
Actual (reported)January 2004
Actual (reported)February 14, 2008
Actual (reported)February 25, 2008
Actual (reported)incidence rate of clinical malaria
in vivo adequate clinical and parasitological response of P. falciparum to SP
Control group
Test group
Subjecs randomized to receive two intermittent preventive treatments with standard recommended treatment doses of Sulfadoxine-pyrimethamine at 8 weeks interval during the peak malaria transmission season.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Malaria Research and Training Center, Faculty of Medicine Pharmacy and Dentistry, University of Bamako
Bamako, Mali
Dicko A, Sagara I, Sissoko MS, Guindo O, Diallo AI, Kone M, Toure OB, Sacko M, Doumbo OK. Impact of intermittent preventive treatment with sulphadoxine-pyrimethamine targeting the transmission season on the incidence of clinical malaria in children in Mali. Malar J. 2008 Jul 8;7:123. doi: 10.1186/1475-2875-7-123.
Ogobara Doumbo, MD
University of Bamako
Alassane Dicko, MD
University of Bamako
262 participants (actual enrollment reported by the registry).
First Submitted
February 14, 2008
First Posted
February 25, 2008
Study Start
July 2002
Date type not reportedThis date has not been verified as actual or estimated.
Combination Antimalarials in Uncomplicated Malaria
Contact the study team to confirm eligibility.
Primary Completion
July 2003
Actual (reported)Study Completion
January 2004
Actual (reported)Last Updated
February 25, 2008
Record last verified: 2002-09
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Source: ClinicalTrials.gov.
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