Treatment of Malaria in Gabon With Fosmidomycin-Clindamycin

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Malaria

Intervention / Treatment
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* Drug: Fosmidomycin-clindamycin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fosmidomycin-clindamycin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients cured by day 14 |  |  | 
| Incidence of adverse events after the start of treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parasite clearance time |  |  | 
| Fever clearance time |  |  | 
| PCR corrected day 28 cure rate |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malaria, Fosmidomycin, Clindamycin, Gabon