Efficacy of Fosmidomycin-Clindamycin for Treating Malaria in Gabonese Children
Information source: Albert Schweitzer Hospital, Netherlands
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Malaria
Intervention: Fosmidomycin-clindamycin (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Albert Schweitzer Hospital, Netherlands
Official(s) and/or principal investigator(s):
Saadou Issifou, MD, Principal Investigator, Affiliation: Medical Research Unit, Lambaréné
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.
Official title: A Comparative Assessment of the Efficacy of Fosmidomycin-Clindamycin Versus Sulfadoxine-Pyrimethamine for the Treatment of Children With Uncomplicated Plasmodium Falciparum Malaria
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Clinical and parasitological cure rate by day 28
Safety and tolerability of the two treatments during the entire study period
Parasite clearance time
Fever clearance time
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.
Minimum age: 3 Years.
Maximum age: 14 Years.
- 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
- 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
Locations and Contacts
Medical Research Unit, Lambaréné, Lambaréné, Moyen Ogooué B.P. 118, Gabon
General information on malaria at the website of the Malaria International Foundation
Homepage of the Medical Research Unit, Lambaréné
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Starting date: June 2005
Ending date: July 2006
Last updated: May 22, 2006