Status:
COMPLETED
Efficacy of Amodiaquine-artesunate in Children Aged 6-59 Months With Uncomplicated P. Falciparum Malaria
Lead Sponsor:
Centers for Disease Control and Prevention
Collaborating Sponsors:
London School of Hygiene and Tropical Medicine
Kenya Medical Research Institute
Conditions:
Malaria
Eligibility:
All Genders
6-59 years
Phase:
PHASE4
Brief 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 preventi...
Detailed Description
We propose to conduct an amodiaquine-artesunate efficacy trial at Bondo District Hospital in Kenya. The results will enable us to better interpret the results of the main IPTi trial. We will assess th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00425763
Start Date
May 1 2007
End Date
August 1 2007
Last Update
April 5 2012
Active Locations (1)
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1
Bondo District Hospital
Kisumu, Kenya