Malaria
Conditions
Keywords
Malaria, Fosmidomycin, Clindamycin, Gabon
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.
Interventions
DRUGFosmidomycin-clindamycin
Sponsors
Albert Schweitzer Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Months to 14 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients cured by day 14 | — |
| Incidence of adverse events after the start of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Parasite clearance time | — |
| Fever clearance time | — |
| PCR corrected day 28 cure rate | — |
Countries
Gabon
Outcome results
None listed