Status:
COMPLETED
Kintampo Trial of Combination Therapy for Malaria
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Collaborating Sponsors:
Kintampo Health Research Centre, Ghana
Conditions:
Malaria
Eligibility:
All Genders
6-10 years
Phase:
PHASE4
Brief Summary
Case management is one of the key strategies for malaria control in most endemic countries. Plasmodium falciparum malaria is becoming resistant to commonly used and cheap antimalarial drugs such as ch...
Detailed Description
A study funded by the GMP-LSHTM in the Kintampo district of Ghana is currently assessing the efficacy of SP as part of a comprehensive process of characterising the site into the patterns of seasonal ...
Eligibility Criteria
Inclusion
- Age 6 months to 10 years
- Body weight \>5 kg
- Uncomplicated P. falciparum malaria
- Mono-infection with P. falciparum
- Asexual parasite density 2,000 to 200,000 parasites/µl
- Haemoglobin ≥7.0 g/dL
- Axillary temperature ≥37.5ºC or history of fever in preceding 24 hr
- Ability to tolerate oral therapy
- Residence in study area
Exclusion
- Haemoglobin \<7.0 g/dL
- Leucocyte count: \>15,000/µL
- G6PD deficiency
- Mixed malaria infections
- Danger signs (unable to drink; repeated vomiting; recent history of convulsions; lethargic or unconscious state; unable to stand up or to sit) and signs of severe malaria as defined by WHO
- Any other severe underlying disease (cardiac, renal, hepatic diseases, malnutrition, known HIV infection)
- Concomitant disease masking assessment of response, e.g. known or suspected hearing impairments
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2006
Estimated Enrollment :
510 Patients enrolled
Trial Details
Trial ID
NCT00119145
Start Date
June 1 2005
End Date
May 1 2006
Last Update
January 12 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Kintampo Health Research Centre
Kintampo, Brong Ahafo Region, Ghana