NCT00217451

Treatment of Malaria in Gabon With Fosmidomycin-Clindamycin

Evaluation of Fosmidomycin in Combination With Clindamycin in Children With Acute Uncomplicated Plasmodium Falciparum Malaria

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (planned)
• Sponsor: Albert Schweitzer Hospital · Academic / Other
• Sex: All
• Age: 12 Months – 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malaria

Interventions

Type	Name	Description
DRUG	Fosmidomycin-clindamycin

Timeline

• Start date: 2002-06-01
• Completion: 2003-03-01
• First posted: 2005-09-22
• Last updated: 2005-09-22

Locations

1 site across 1 country: Gabon