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A study comparing the efficacy of clindamycin plus quinine with coartem for treating Kenyan children with uncomplicated falciparum malaria

An open-label randomized controlled trial of the efficacy and safety of clindamycin plus quinine compared with artemether-lumefantrine for the treatment of children with uncomplicated falciparum malaria in western Kenya

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR201209000419241
Enrollment
384
Registered
2012-09-25
Start date
2012-11-01
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria

Interventions

Clindamycin
Artemether-lumefantrine

Sponsors

Kenya Medical Research Institute
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Cure rate

Secondary

MeasureTime frame
Fever resolution rate;parasite clearance rate;gametocyte carriage;haemoglobin

Countries

Kenya

Contacts

Public ContactJohn Vulule

Centre Director, KEMRI Kisumu

JVulule@yahoo.com+254 722679547

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Mar 2, 2026