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NCT Number: NCT00214643

Efficacy of Fosmidomycin-Clindamycin for Treating Malaria in Gabonese Children

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.

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Key information

Conditions

Malaria Infections Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

3 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medical Research Unit, Lambaréné

Lambaréné, Moyen-Ogooué Province, B.P. 118, Gabon

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fosmidomycin

Drug

30 mg/kg

Clindamycin

Drug

10 mg/kg

Primary outcomes

  1. Clinical and parasitological cure rate by day 28

Secondary outcomes

  1. Safety and tolerability of the two treatments during the entire study period

  2. Parasite clearance time

  3. Fever clearance time

Sponsors and collaborators

Lead sponsor

Albert Schweitzer Hospital, Netherlands

Unknown

Collaborators

  • Albert Schweitzer Hospital

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2006
First posted
Sep 22, 2005
Registry last updated
Feb 4, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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