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NCT Number: NCT00217451

Treatment of Malaria in Gabon With Fosmidomycin-Clindamycin

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.

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Key information

Conditions

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

Age range

12 month–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medical Research Unit, Lambaréné

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Fosmidomycin-clindamycin

Drug

Primary outcomes

  1. Proportion of patients cured by day 14

  2. Incidence of adverse events after the start of treatment

Secondary outcomes

  1. Parasite clearance time

  2. Fever clearance time

  3. PCR corrected day 28 cure rate

Sponsors and collaborators

Lead sponsor

Albert Schweitzer Hospital

Other

Registry information

Official study title

Evaluation of Fosmidomycin in Combination With Clindamycin in Children With Acute Uncomplicated Plasmodium Falciparum Malaria

Important dates

Study start
2002
Study completion
2003
First posted
Sep 22, 2005
Registry last updated
Sep 22, 2005

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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