Malaria
Conditions
Keywords
Malaria, Fosmidomycin, Clindamycin, Chemotherapy, Gabon
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.
Interventions
DRUGFosmidomycin
30 mg/kg
DRUGclindamycin
10 mg/kg
Sponsors
Albert Schweitzer Hospital
Albert Schweitzer Hospital, Netherlands
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 14 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical and parasitological cure rate by day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability of the two treatments during the entire study period | — |
| Parasite clearance time | — |
| Fever clearance time | — |
Countries
Gabon
Outcome results
None listed