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Treatment of Malaria in Gabon With Fosmidomycin-Clindamycin
This study has been completed.
Study NCT00217451   Information provided by Albert Schweitzer Hospital
First Received: September 12, 2005   Last Updated: September 19, 2005   History of Changes

September 12, 2005
September 19, 2005
June 2002
 
  • Proportion of patients cured by day 14
  • Incidence of adverse events after the start of treatment
Same as current
Complete list of historical versions of study NCT00217451 on ClinicalTrials.gov Archive Site
  • Parasite clearance time
  • Fever clearance time
  • PCR corrected day 28 cure rate
Same as current
 
Treatment of Malaria in Gabon With Fosmidomycin-Clindamycin
Evaluation of Fosmidomycin in Combination With Clindamycin in Children With Acute Uncomplicated Plasmodium Falciparum Malaria

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.

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.

Phase II
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Malaria
Drug: Fosmidomycin-clindamycin
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
51
March 2003
 

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.
Both
12 Months to 14 Years
No
Contact information is only displayed when the study is recruiting subjects
Gabon
 
NCT00217451
 
06/2002/FOS-CLIN/JP006
Albert Schweitzer Hospital
Medical Research Unit, Lambaréné
Principal Investigator: Steffen Borrmann, MD Kenya Medical Research Institute, Centre for Geographic Medicine Research, Coast, kilifi, Kenya
Principal Investigator: Peter G. Kremsner, MD, FRCP Medical Research Unit, Lambaréné
Albert Schweitzer Hospital
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP