Status:
COMPLETED
Efficacy of Fosmidomycin-Clindamycin for Treating Malaria in Gabonese Children
Lead Sponsor:
Albert Schweitzer Hospital, Netherlands
Collaborating Sponsors:
Albert Schweitzer Hospital
Conditions:
Malaria
Eligibility:
All Genders
3-14 years
Phase:
PHASE3
Brief Summary
There is a necessity for the development of new malaria drugs. Some antibiotics are also effective against malaria parasites. Fosmidomycin is an antibiotic that has been shown to be effective against ...
Detailed Description
Fosmidomycin-clindamycin (30 mg/kg and 10 mg/kg) given twice daily for three days is an effective and safe combination of antibiotics which demonstrated good activity against malaria parasite in previ...
Eligibility Criteria
Inclusion
- Uncomplicated P. falciparum malaria
- P. falciparum asexual parasitaemia between 1,000/µL and 100,000/µL
- Body weight between 10 - 65 kg
- Ability to tolerate oral therapy
- Informed consent, oral assent of the child, if possible
- Residence in study area
Exclusion
- Adequate anti-malarial treatment within the previous 7 days
- Antibiotic treatment for the current infection
- Previous participation in this clinical trial
- Haemoglobin \< 7 g/dl
- Haematocrit \< 23 %
- Leucocyte count \> 15,000 /µL
- Mixed plasmodial infection
- 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
- History of allergy or intolerance against trial medication
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
End Date :
July 1 2006
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00214643
Start Date
June 1 2005
End Date
July 1 2006
Last Update
February 4 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Medical Research Unit, Lambaréné
Lambaréné, Moyen-Ogooué Province, Gabon, B.P. 118