Treatment of Malaria in Gabon With Fosmidomycin-Clindamycin

September 19, 2005 updated by: Albert Schweitzer Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment

51

Phase

  • Phase 2

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 months to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Proportion of patients cured by day 14
Incidence of adverse events after the start of treatment

Secondary Outcome Measures

Outcome Measure
Parasite clearance time
Fever clearance time
PCR corrected day 28 cure rate

Collaborators and Investigators

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

Sponsor

Albert Schweitzer Hospital

Investigators

  • Principal Investigator: Steffen Borrmann, MD, Kenya Medical Research Institute, Centre for Geographic Medicine Research, Coast, kilifi, Kenya
  • Principal Investigator: Peter G. Kremsner, MD, FRCP, 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, 2002

Study Completion

March 1, 2003

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 19, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

September 22, 2005

Last Update Submitted That Met QC Criteria

September 19, 2005

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06/2002/FOS-CLIN/JP006

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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