Clinical trial NCT00214643: Efficacy of Fosmidomycin-Clindamycin for Treating Malaria in Gabonese Children
Official title: A Comparative Assessment of the Efficacy of Fosmidomycin-Clindamycin Versus Sulfadoxine-Pyrimethamine for the Treatment of Children With Uncomplicated Plasmodium Falciparum Malaria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Malaria
Keywords: Malaria
Fosmidomycin
Clindamycin
Chemotherapy
Gabon
Lead sponsor: Albert Schweitzer Hospital
Sponsor class: OTHER
Collaborators: name: Albert Schweitzer Hospital
First posted: 2005-09-22
Enrollment: 160
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical and parasitological cure rate by day 28
Secondary outcomes:
measure: Safety and tolerability of the two treatments during the entire study period
measure: Parasite clearance time
measure: Fever clearance time
Other outcomes:
Locations:
city: Lambaréné
country: Gabon
facility: Medical Research Unit, Lambaréné
state: Moyen Ogooué
Study officials:
affiliation: Albert Schweitzer Hospital
name: Saadou Issifou, MD
role: PRINCIPAL_INVESTIGATOR
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