Efficacy of Fosmidomycin-Clindamycin for Treating Malaria in Gabonese Children

Phase 3

Completed

• Conditions: Malaria

• Registration Number: NCT00214643
• Lead Sponsor: Albert Schweitzer Hospital

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 malaria, although it cannot achieve a total cure in all patients. Previous small studies have shown that in combination with clindamycin, an commonly used antibiotic, it is highly effective and safe when given for three days, leading to a total cure in most patients. The current study will evaluate its efficacy in a larger population in Gabon, and compare its effect with the generally used drug, sulfadoxine-pyrimethamine.

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 previous phase II studies in African children. In this phase III trial, the efficacy and safety of the combination will be evaluated in African children with uncomplicated P. falciparum malaria. A single dose of sulfadoxine-pyrimethamine, the standard antimalarial in Gabon, is used as comparator.

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-09-11
• Study First Submitted QC: 2005-09-19
• Study First Posted: 2005-09-22
• Study Completion: 2006-07
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-03
• Last Update Posted: 2009-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical and parasitological cure rate by day 28

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability of the two treatments during the entire study period
Parasite clearance time
Fever clearance time

Trial Locations

Locations (1)

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