A Trial of the Combined Impact of Intermittent Preventive Treatment and Insecticide Treated Bednets in Reducing Morbidity From Malaria in African Children

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Trial of the Combined Impact of Intermittent Preventive Treatment and Insecticide Treated Bednets in Reducing Morbidity From Malaria in African Children

Conditions
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Malaria

Intervention / Treatment
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* Drug: Intermittent preventive treatment with AQ+ SP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Permanent residence in the study area with no intention of leaving during the surveillance period. Obtention of informed consent. Exclusion Criteria: Temporary residence in the study area. Absence of informed consent. Presence of a severe, chronic illness such as severe malnutrition (Kwashiorkor or marasmus) or AIDS, likely to interfere with evaluation of the trial results. A history of a previous, significant adverse reaction to either of the study drugs.

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 59 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2<br>Amodiaquine+pyrimethamine versus placebo | Drug: Intermittent preventive treatment with AQ+ SP<br>* 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<br>* Other names: IPTc;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of clinical malaria |  | 2008-2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of severe malaria, Incidence of anemia, Prevalence of anemia, Prevalence of parasitemia, Proportion of children with parasites carrying resistance markers to AQ and SP, Incidence of hospital admissions due to malaria. |  | 2008-2009 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intermittent Preventive treatment, insecticide treated bednets, malaria