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

• Register: PACTR
• Last refreshed on: 29 April 2013
• Main ID: PACTR201209000419241
• Date of registration: 25/09/2012
• Primary sponsor: Kenya Medical Research Institute
• Public title: A study comparing the efficacy of clindamycin plus quinine with coartem for treating Kenyan children with uncomplicated falciparum malaria
• Scientific title: 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
• Date of first enrolment: 2012-11-01
• Target sample size: 384
• Recruitment status: Not yet recruiting
• URL: HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201209000419241
• Study type: interventional
• Study design: Parallel: different groups receive different interventions at same time during study,; Randomised,; permuted block randomisation,; Numbered containers,

Countries of recruitment

South Africa

Contacts

• Name: John Vulule
• Affiliation: Centre Director, KEMRI Kisumu

• Name: Charles Obonyo
• Affiliation: Scientist, KEMRI

Key inclusion & exclusion criteria

Inclusion criteria: 1. Age 6-59 months
2. Axillary temperature equal to or above 37.5? 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:
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.


Age minimum: 6 Month
Age maximum: 59 Month
Gender: Both

Health Condition(s) or Problem(s) studied

Malaria
null

Primary Outcome(s)

Cure rate

Secondary Outcome(s)

Fever resolution rate

gametocyte carriage

haemoglobin

parasite clearance rate

Secondary ID(s)

KEMRI SSC No 2357

Source(s) of Monetary Support

EDCTP