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...
Date First Received: September 12, 2005
Last Updated: September 19, 2005
Verified by: Albert Schweitzer Hospital, Netherlands, September 2005
Clinical Trial Phase: Phase 2 | Start Date: June 2002
Overall Status: Completed
Estimated Enrollment: 51
Brief Summary
Official Title: “Evaluation of Fosmidomycin in Combination With Clindamycin in Children With Acute Uncomplicated Plasmodium Falciparum Malaria”
Condition Keyword(s):
Intervention(s):
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 Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: Fosmidomycin-clindamycin
Outcome Measures for this Clinical Trial
Primary Measures
- Proportion of patients cured by day 14
- Incidence of adverse events after the start of treatment
Secondary Measures
- Parasite clearance time
- Fever clearance time
- PCR corrected day 28 cure rate
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 12 Months
Maximum Age for this Clinical Trial: 14 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Albert Schweitzer Hospital, Netherlands
Overall Clinical Trial Officials and Contacts
Steffen Borrmann, MD Principal Investigator Kenya Medical Research Institute, Centre for Geographic Medicine Research, Coast, kilifi, Kenya
Related Publications
References
Beytia ED, Porter JW. Biochemistry of polyisoprenoid biosynthesis. Annu Rev Biochem. 1976;45:113-42. Review. No abstract available.
Lois LM, Campos N, Putra SR, Danielsen K, Rohmer M, Boronat A. Cloning and characterization of a gene from Escherichia coli encoding a transketolase-like enzyme that catalyzes the synthesis of D-1-deoxyxylulose 5-phosphate, a common precursor for isoprenoid, thiamin, and pyridoxol biosynthesis. Proc Natl Acad Sci U S A. 1998 Mar 3;95(5):2105-10.
Rohmer M, Knani M, Simonin P, Sutter B, Sahm H. Isoprenoid biosynthesis in bacteria: a novel pathway for the early steps leading to isopentenyl diphosphate. Biochem J. 1993 Oct 15;295 ( Pt 2):517-24.
Jomaa H, Wiesner J, Sanderbrand S, Altincicek B, Weidemeyer C, Hintz M, Turbachova I, Eberl M, Zeidler J, Lichtenthaler HK, Soldati D, Beck E. Inhibitors of the nonmevalonate pathway of isoprenoid biosynthesis as antimalarial drugs. Science. 1999 Sep 3;285(5433):1573-6.
Clinical study report for Protocol JP 001 – Evaluation of fosmidoymcin in adult patients with acute uncomplicated Plasmodium falciparum malaria. 2001. World Health Organisation, Geneva, Switzerland and Jomaa Pharmaka GmbH, Germany
Wiesner J, Henschker D, Hutchinson DB, Beck E, Jomaa H. In vitro and in vivo synergy of fosmidomycin, a novel antimalarial drug, with clindamycin. Antimicrob Agents Chemother. 2002 Sep;46(9):2889-94.
Additional Information
Information obtained from ClinicalTrials.gov on December 03, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00217451
Study ID Number: 06/2002/FOS-CLIN/JP006
ClinicalTrials.gov Identifier: NCT00217451
Health Authority: Gabon: Ministry of Research
General information on malaria at the website of the Malaria Foundation International
Clinical Trials Authorship and Review
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