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Sponsors and Collaborators: |
London School of Hygiene and Tropical Medicine Centre National de Recherche et de Formation sur le Paludisme, Burkina Faso Malaria Research and Training Centre, Mali |
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Information provided by: | London School of Hygiene and Tropical Medicine |
ClinicalTrials.gov Identifier: | NCT00738946 |
An investigation will be made of the combined impact of insecticide-treated nets and intermittent preventive treatment with amodiaquine + sulfadoxine-pyrimethamine on malaria morbidity in children in Burkina Faso and Mali.Three rounds of treatment will be given during the malaria season in one year and the follow-up will be extended into the second year by passive surveillance.
Condition | Intervention |
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Malaria |
Drug: Intermittent preventive treatment with AQ+ SP |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment |
Official Title: | A Trial of the Combined Impact of Intermittent Preventive Treatment and Insecticide Treated Bednets in Reducing Morbidity From Malaria in African Children |
Estimated Enrollment: | 6000 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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2: Experimental
Amodiaquine+pyrimethamine versus placebo
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Drug: Intermittent preventive treatment with AQ+ SP
Amodiaquine (10 mg/kg over 3 days) and Sulfadoxine Pyrimethamine (25 mg of sulfadoxine + 1.25 mg of pyrimethamine per kg in a single dose) or placebo administered over 3 rounds of one month interval
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The trial will be conducted in 6000 children in Burkina Faso and Mali in 2008 and 2009. Each site will enroll 3,000 children. All children will be allocated a long lasting insecticide-treated net and randomized to receive to treatment (amodiaquine + sulfadoxine-pyrimethamine (AQ+SP)) or placebo (AQ-placebo + SP-placebo. Treatment will be administered over 3 rounds during the high malaria transmission season, with one month interval between rounds. Full course treatment of AQ and SP will be administered on each occasion. Treatment will not be given in the second year. Passive surveillance of malaria will be implemented for the monitoring of malaria morbidity and to assess whether children who received intermittent preventive treatment (IPT) are at increased risk of malaria.
Adverse events will be monitored during each round of IPT administration. To assess the effect of IPTc on the prevalence of malaria infection, a random sample of 150 children will be visited every week during the high malaria transmission period. This number will be increased to 300 during the low transmission season, but the survey will be reduced to monthly visits. Baseline prevalence of genetic markers of resistance to SP and AQ will be estimated. A second cross-sectional survey will be conducted at the end of the malaria transmission season to assess the effect of IPT on the prevalence of genetic markers of resistance to SP and AQ, on the prevalence of anaemia and on nutritional indicators.
Ages Eligible for Study: | 3 Months to 59 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Burkina Faso, Kadiogo | |
Centre National de Recherche et de Formation sur le Paludisme | Recruiting |
Ouagadougou, Kadiogo, Burkina Faso, BP 2208 | |
Contact: Amadou T Konaté, MD, PhD +226 70 262965 a.konate.cnlp@fasonet.bf | |
Principal Investigator: Amadou T Konaté, MD, PhD | |
Mali | |
Malaria Research and Training Centre | Recruiting |
Bamako, Mali | |
Contact: Alassane Dicko, MD, MSc +2236742296 adicko@mrtcbko.org | |
Principal Investigator: Alassane Dicko, MD, MSc |
Study Director: | Brian M Greenwood, MD, FRCP | London School of Hygiene and Tropical Medicine |
Responsible Party: | London School of Hygiene and Tropical Medicine ( Professor Brian Greenwood ) |
Study ID Numbers: | IPTCVP17 |
Study First Received: | August 20, 2008 |
Last Updated: | August 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00738946 History of Changes |
Health Authority: | United Kingdom: Research Ethics Committee; Mali: Ministry of Health; Burkina Faso: Ministry of Health |
Intermittent Preventive treatment insecticide treated bednets malaria |
Pyrimethamine Protozoan Infections Amodiaquine Sulfadoxine-pyrimethamine |
Parasitic Diseases Malaria Sulfadoxine |
Protozoan Infections Coccidiosis Parasitic Diseases Malaria |