Efficacy of Fosmidomycin-Clindamycin for Treating Malaria in Gabonese Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Comparative Assessment of the Efficacy of Fosmidomycin-Clindamycin Versus Sulfadoxine-Pyrimethamine for the Treatment of Children With Uncomplicated Plasmodium Falciparum Malaria

Conditions
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Malaria

Intervention / Treatment
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* Drug: Fosmidomycin
* Drug: clindamycin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fosmidomycin|30 mg/kg|
|Drug: clindamycin|10 mg/kg|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical and parasitological cure rate by day 28 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of the two treatments during the entire study period |  |  | 
| Parasite clearance time |  |  | 
| Fever clearance time |  |  | 

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