Clinical trial NCT00217451: Treatment of Malaria in Gabon With Fosmidomycin-Clindamycin
Official title: Evaluation of Fosmidomycin in Combination With Clindamycin in Children With Acute Uncomplicated Plasmodium Falciparum Malaria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Malaria
Keywords: Malaria
Fosmidomycin
Clindamycin
Gabon
Lead sponsor: Albert Schweitzer Hospital
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 51
Sex: ALL
Minimum age (years): 12
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients cured by day 14
measure: Incidence of adverse events after the start of treatment
Secondary outcomes:
measure: Parasite clearance time
measure: Fever clearance time
measure: PCR corrected day 28 cure rate
Other outcomes:
Locations:
city: Lambaréné
country: Gabon
facility: Medical Research Unit, Lambaréné
state: Moyen Ogooué
Study officials:
affiliation: Kenya Medical Research Institute, Centre for Geographic Medicine Research, Coast, kilifi, Kenya
name: Steffen Borrmann, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Albert Schweitzer Hospital
name: Peter G. Kremsner, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
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