Efficacy of Fosmidomycin-Clindamycin for Treating Malaria in Gabonese Children

February 3, 2009 updated by: Albert Schweitzer Hospital

A Comparative Assessment of the Efficacy of Fosmidomycin-Clindamycin Versus Sulfadoxine-Pyrimethamine for the Treatment of Children With Uncomplicated Plasmodium Falciparum Malaria

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment

160

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Gabon
    • Moyen Ogooué
      • Lambaréné, Moyen Ogooué, Gabon, B.P. 118
        • Medical Research Unit, Lambaréné

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Clinical and parasitological cure rate by day 28

Secondary Outcome Measures

Outcome Measure
Parasite clearance time
Fever clearance time
Safety and tolerability of the two treatments during the entire study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albert Schweitzer Hospital

Investigators

  • Principal Investigator: Saadou Issifou, MD, Albert Schweitzer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Study Completion

July 1, 2006

Study Registration Dates

First Submitted

September 11, 2005

First Submitted That Met QC Criteria

September 19, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

February 4, 2009

Last Update Submitted That Met QC Criteria

February 3, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06/2005/FOS-CLIN/SP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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