Efficacy of Fosmidomycin-Clindamycin for Treating Malaria in Gabonese Children

This study has been completed.
Sponsor:
Information provided by:
Albert Schweitzer Hospital
ClinicalTrials.gov Identifier:
NCT00214643
First received: September 11, 2005
Last updated: February 3, 2009
Last verified: February 2009
  Purpose

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.


Condition Intervention Phase
Malaria
Drug: Fosmidomycin
Drug: clindamycin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparative Assessment of the Efficacy of Fosmidomycin-Clindamycin Versus Sulfadoxine-Pyrimethamine for the Treatment of Children With Uncomplicated Plasmodium Falciparum Malaria

Resource links provided by NLM:


Further study details as provided by Albert Schweitzer Hospital:

Primary Outcome Measures:
  • Clinical and parasitological cure rate by day 28

Secondary Outcome Measures:
  • Safety and tolerability of the two treatments during the entire study period
  • Parasite clearance time
  • Fever clearance time

Estimated Enrollment: 160
Study Start Date: June 2005
Estimated Study Completion Date: July 2006
Intervention Details:
    Drug: Fosmidomycin
    30 mg/kg
    Drug: clindamycin
    10 mg/kg
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.

  Eligibility

Ages Eligible for Study:   3 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00214643

Locations
Gabon
Medical Research Unit, Lambaréné
Lambaréné, Moyen Ogooué, Gabon, B.P. 118
Sponsors and Collaborators
Albert Schweitzer Hospital
Investigators
Principal Investigator: Saadou Issifou, MD Albert Schweitzer Hospital
  More Information

Additional Information:
Publications:
Kuzuyama T, Shizimu T, Takashi S and Seto H. Fosmidomycin, a specific inhibitor of 1-deoxy-D-xylulose 5-phosphate reductoisomerase in the nonmevalonate pathway of isoprenoid biosynthesis. Tetrahaedron Lett 1998;39:7913-6
Zeidler J, Schwender J, Müller C, et al. Inhibition of the non-mevalonate 1-deoxy-D-xylulose-5-phosphate pathway of plant isoprenoid biosynthesis by fosmidomycin. Z Naturforsch 1998;53:980-6

ClinicalTrials.gov Identifier: NCT00214643     History of Changes
Other Study ID Numbers: 06/2005/FOS-CLIN/SP
Study First Received: September 11, 2005
Last Updated: February 3, 2009
Health Authority: Gabon: Ministry of Research

Keywords provided by Albert Schweitzer Hospital:
Malaria
Fosmidomycin
Clindamycin
Chemotherapy
Gabon

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Fosfomycin
Fanasil, pyrimethamine drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on August 21, 2014