A study comparing the efficacy of clindamycin plus quinine with coartem for treating Kenyan children with uncomplicated falciparum malaria
- Conditions
- Malaria
- Registration Number
- PACTR201209000419241
- Lead Sponsor
- Kenya Medical Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 384
1. Age 6-59 months
2. Axillary temperature equal to or above 37.5º C or history of fever in the past 48 hours
3. Body weight above 5.0 kg
4. Slide-confirmed infection with P. falciparum
5. Parasitaemia 2,000-200,000 asexual forms per microlitre
6. Parent/guardian provides informed consent
1. Presence of general danger signs or other signs of severe malaria and complicated falciparum malaria according to current WHO definitions.
2. Mixed or mono-infection with another Plasmodium species.
3. Presence of severe malnutrition, defined as weight-for-age below 3 standard deviations below the mean (NCHS/WHO normalized reference values).
4. Known hypersensitivity to any of the drugs being tested.
5. Presence of febrile conditions caused by diseases other than malaria.
6. Presence of other serious or chronic medical conditions (heart failure, sickle cell disease).
7. Plan to travel or leave the area within the next 3 months
8. Inability to swallow oral medication
9. Residence beyond 10km of the catchment area of the study hospital.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cure rate
- Secondary Outcome Measures
Name Time Method Fever resolution rate;parasite clearance rate;gametocyte carriage;haemoglobin