Treatment of Malaria in Gabon With Fosmidomycin-Clindamycin - Full Text View

Sponsors and Collaborators:	Albert Schweitzer Hospital, Netherlands Medical Research Unit, Lambaréné
Information provided by:	Albert Schweitzer Hospital, Netherlands
ClinicalTrials.gov Identifier:	NCT00217451

Purpose

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.

Condition	Intervention	Phase
Malaria	Drug: Fosmidomycin-clindamycin	Phase II

MedlinePlus related topics: Antibiotics Malaria

Drug Information available for: Clindamycin Clindamycin hydrochloride Clindamycin palmitate Clindamycin Palmitate Hydrochloride Clindamycin phosphate Fosmidomycin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Evaluation of Fosmidomycin in Combination With Clindamycin in Children With Acute Uncomplicated Plasmodium Falciparum Malaria

Further study details as provided by Albert Schweitzer Hospital, Netherlands:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	51
Study Start Date:	June 2002
Estimated Study Completion Date:	March 2003

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.

Eligibility

Ages Eligible for Study:	12 Months to 14 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00217451

Locations

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

Sponsors and Collaborators

Albert Schweitzer Hospital, Netherlands

Medical Research Unit, Lambaréné

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	Medical Research Unit, Lambaréné

More Information

General information on malaria at the website of the Malaria Foundation International This link exits the ClinicalTrials.gov site

Homepage of Medical Research Unit, Lambaréné This link exits the ClinicalTrials.gov site

Publications:

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.

Study ID Numbers:	06/2002/FOS-CLIN/JP006
Study First Received:	September 12, 2005
Last Updated:	September 19, 2005
ClinicalTrials.gov Identifier:	NCT00217451
Health Authority:	Gabon: Ministry of Research

Keywords provided by Albert Schweitzer Hospital, Netherlands:

Malaria
Fosmidomycin
Clindamycin
Gabon

Study placed in the following topic categories:

Protozoan Infections
Clindamycin
Clindamycin-2-phosphate

Parasitic Diseases
Malaria
Malaria, Falciparum

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Protein Synthesis Inhibitors
Molecular Mechanisms of Pharmacological Action

Coccidiosis
Therapeutic Uses
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009