Efficacy of Amodiaquine-artesunate in Children Aged 6-59 Months With Uncomplicated P. Falciparum Malaria

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centers for Disease Control and Prevention
• Collaborators: Kenya Medical Research Institute; London School of Hygiene and Tropical Medicine
• Treatments: Amodiaquine; Artesunate

Criteria

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