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Efficacy of Fosmidomycin-Clindamycin for Treating Malaria in Gabonese Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00214643
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : February 4, 2009
Information provided by:
Albert Schweitzer Hospital

Tracking Information
First Submitted Date  ICMJE September 11, 2005
First Posted Date  ICMJE September 22, 2005
Last Update Posted Date February 4, 2009
Study Start Date  ICMJE June 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2005)
Clinical and parasitological cure rate by day 28
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00214643 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2005)
  • Safety and tolerability of the two treatments during the entire study period
  • Parasite clearance time
  • Fever clearance time
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Efficacy of Fosmidomycin-Clindamycin for Treating Malaria in Gabonese Children
Official Title  ICMJE A Comparative Assessment of the Efficacy of Fosmidomycin-Clindamycin Versus Sulfadoxine-Pyrimethamine for the Treatment of Children With Uncomplicated Plasmodium Falciparum Malaria
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Malaria
Intervention  ICMJE
  • Drug: Fosmidomycin
    30 mg/kg
  • Drug: clindamycin
    10 mg/kg
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 19, 2005)
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE July 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 14 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Gabon
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00214643
Other Study ID Numbers  ICMJE 06/2005/FOS-CLIN/SP
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Albert Schweitzer Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Saadou Issifou, MD Albert Schweitzer Hospital
PRS Account Albert Schweitzer Hospital
Verification Date February 2009

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