Treatment of Malaria in Gabon With Fosmidomycin-Clindamycin

Albert Schweitzer Hospital

Status and phase: Completed; Phase 2

Conditions: Malaria

Treatments: Drug: Fosmidomycin-clindamycin

Study type: Interventional

Funder types: Other

Identifiers

NCT00217451

06/2002/FOS-CLIN/JP006

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 12 months to 14 years old

Volunteers: No Healthy Volunteers

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

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)