Malaria Clinical Trial
— IPTi DRWGOfficial title:
Efficacy of Amodiaquine-artesunate in the Treatment of Symptomatic, Uncomplicated Plasmodium Falciparum Malaria Among 6-59 Month Old Children at an IPTi Site in Rural Western Kenya
We will be studying the clinical efficacy of amodiaquine-artesunate currently being studied in an intermittent preventive therapy in infants (IPTi)trial in the same area in order to correlate preventive efficacy seen in IPTi with efficacy for treatment of symptomatic malaria for each regimen.
Status | Completed |
Enrollment | 110 |
Est. completion date | August 2007 |
Est. primary completion date | August 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Months to 59 Months |
Eligibility |
Inclusion Criteria: - age 6-59 months - axillary temperature = 37.5º C, or history of fever in previous 24 hours - weight = 5.0 kg - slide-confirmed infection with P. falciparum - parasitemia 2000-200,000 asexual forms per µl - ability and willingness to attend stipulated follow-up visits Exclusion Criteria: - signs or symptoms of severe disease - weight-for-age = 3rd percentile on Kenya growth charts - slide confirmed infection with any other Plasmodium spp., besides falciparum - severe anemia, defined as Hb < 7 g/dl - known hypersensitivity to any of the drugs being tested - enrolled in IPTi trial - known chronic disease |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Kenya | Bondo District Hospital | Kisumu |
Lead Sponsor | Collaborator |
---|---|
Centers for Disease Control and Prevention | Kenya Medical Research Institute, London School of Hygiene and Tropical Medicine |
Kenya,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 28 Day Adequate Clinical and Parasitological Response, Early Treatment Failure, Late Clinical Failure, Late Parasitological | |||
Secondary | Side effects | |||
Secondary | Molecular markers of drug resistance |
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