Malaria | Evaluation of Fosmidomycin and Clindamycin in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria
Malaria research study
What is the primary objective of this study?
Few efficient drugs for malaria treatment are available so far. Due to increased exposure of these drugs and due to the high risk of development of drug resistant strains of Plasmodium falciparum, new drug combinations have to be actively investigated. The investigators will test the efficiency, safety and tolerance of combined fosmidomycin and clindamycin treatment in acute uncomplicated malaria in children aged 3-10 years.
Who is eligible to participate?
Inclusion Criteria: - Male or female subjects aged three to ten years - Body weight ≥12kg - Acute (symptoms lasting less than 14 days) uncomplicated P falciparum malaria - Asexual parasitaemia between 1,000/µL and 200,000/µL - Ability to tolerate oral therapy - Willingness of the parent or guardian to provide informed signed consent Exclusion Criteria: - Symptoms/signs of severe malaria, according to WHO criteria (see appendix I) - Body weight <12kg - Other concomitant plasmodial infections (P vivax, P ovale, P malariae) - Severe malnutrition with weight for height <70% (according to WHO tables) or clinical kwashiorkor - Gastro-intestinal disturbance with persistent vomiting (> three episodes within previous 24 hours) and/or diarrhoea (> 5 loose stools in the preceding 24 hours) - Concomitant disease masking assessment of response including sickle cell disease and severe cardiac, hepatic or renal impairment - Packed cell volume (PCV) on arrival <22% - Adequate anti-malarial treatment within previous 7 days - Inability to tolerate oral therapy - Parent or guardian deemed to be unsupportive - On co-trimoxazole prophylaxis - Any known allergies to the investigational products
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Fosmidomycin and clindamycinThe study drugs will be co-administered under supervision by a study physician or nurse in doses of fosmidomycin 30mg/kg/dose + clindamycin 10mg/kg/dose twice daily for three days (total daily dose fosmidomycin 60mg/kg, clindamycin 20mg/kg).
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Fosmidomycin and clindamycin treatmentAll the subject will be given fosmidomycin 30mg/kg/dose + clindamycin 10mg/kg/dose twice daily for three days (total daily dose fosmidomycin 60mg/kg, clindamycin 20mg/kg).
Start Date: June 2011
Completed Date: December 2011
Phase: Phase 2
Primary Outcome: Cure rate
Secondary Outcome: cure rate
Study sponsors, principal investigator, and references
Principal Investigator: Saadou Issifou, MD PhD
Lead Sponsor: Zentopharm GmbH
Collaborator: Albert Schweitzer Hospital