Treatment of Malaria in Gabon With Fosmidomycin-Clindamycin

Phase 2

Completed

• Conditions: Malaria

• Registration Number: NCT00217451
• Lead Sponsor: Albert Schweitzer Hospital

Brief Summary

Some antibiotics are also effective against malaria parasites. Fosmidomycin is an antibiotic that has been shown to be effective against malaria, although it cannot achieve a total cure in all patients. A previous small study has shown that in combination with clindamycin, an commonly used antibiotic, it is highly effective and safe, in asymptomatic carriers of malaria parasites. The current study will evaluate the efficacy and safety of the combination given for three days in children with uncomplicated malaria in Gabon.

Detailed Description

The treatment of malaria is becoming increasingly difficult due to the development of Plasmodium falciparum strains resistant to commonly used antimalarials. Fosmidomycin was shown to be well tolerated and fast-acting in paediatric outpatients and adults, but late recrudescences preclude its use as monotherapy. Clindamycin was identified as a suitable combination partner following the demonstration of synergistic inhibition of plasmodial growth by in vitro and animal studies.

In this study, the safety and efficacy of fosmidomycin-clindamycin (30 mg/kg plus 10 mg/kg) twice daily for three days is assessed in children with acute uncomplicated P. falciparum malaria.

Study Timeline

• Study Start: 2002-06
• Study Completion: 2003-03
• Status Verified: 2005-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-19
• Last Update Submitted: 2005-09-19
• Study First Posted: 2005-09-22
• Last Update Posted: 2005-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• Uncomplicated P. falciparum malaria with acute manifestation
• Asexual parasitemia between 1,000-100,000/μL
• Body weight between 5-65 kg
• Ability to tolerate oral therapy
• Informed consent, oral agreement of the child if appropriate
• Residence in the study area for the duration of at least 4 weeks

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Exclusion Criteria

• Adequate anti-malarial treatment within the previous 7 days
• Antibiotic treatment for a concurrent infection
• Haemoglobin <7g/dL
• Hematocrit <25%
• Leukocyte count >15,000/μL
• Mixed plasmodial infection
• Severe malaria, any other severe underlying disease
• Concomitant disease masking assessment of treatment response
• Inflammatory bowel disease, and any other disease causing fever.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Proportion of patients cured by day 14
Incidence of adverse events after the start of treatment

Secondary Outcome Measures

Name	Time	Method
Parasite clearance time
Fever clearance time
PCR corrected day 28 cure rate

Trial Locations

Locations (1)

Medical Research Unit, Lambaréné; 🇬🇦 Lambaréné, Moyen Ogooué, Gabon