Malaria Clinical Trial
— IPTc/ITNsOfficial title:
A Trial of the Combined Impact of Intermittent Preventive Treatment and Insecticide Treated Bednets in Reducing Morbidity From Malaria in African Children
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.
Status | Completed |
Enrollment | 6000 |
Est. completion date | December 2009 |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 3 Months to 59 Months |
Eligibility |
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Burkina Faso | Centre National de Recherche et de Formation sur le Paludisme | Ouagadougou | Kadiogo |
Mali | Malaria Research and Training Centre | Bamako |
Lead Sponsor | Collaborator |
---|---|
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 |
Burkina Faso, Mali,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of clinical malaria | 2008-2009 | No | |
Secondary | 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 | Yes |
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