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Treatment of Malaria in Gabon With Fosmidomycin-Clindamycin

NCT ID: NCT00217451

Last Updated: 2005-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2003-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Malaria

Keywords

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Malaria Fosmidomycin Clindamycin Gabon

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Fosmidomycin-clindamycin

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

12 Months

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Albert Schweitzer Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Steffen Borrmann, MD

Role: PRINCIPAL_INVESTIGATOR

Kenya Medical Research Institute, Centre for Geographic Medicine Research, Coast, kilifi, Kenya

Peter G. Kremsner, MD, FRCP

Role: PRINCIPAL_INVESTIGATOR

Albert Schweitzer Hospital

Locations

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Medical Research Unit, Lambaréné

Lambaréné, Moyen-Ogooué Province, Gabon

Site Status

Countries

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Gabon

References

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Beytia ED, Porter JW. Biochemistry of polyisoprenoid biosynthesis. Annu Rev Biochem. 1976;45:113-42. doi: 10.1146/annurev.bi.45.070176.000553. No abstract available.

Reference Type BACKGROUND
PMID: 9026 (View on PubMed)

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. doi: 10.1073/pnas.95.5.2105.

Reference Type BACKGROUND
PMID: 9482846 (View on PubMed)

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)(Pt 2):517-24. doi: 10.1042/bj2950517.

Reference Type BACKGROUND
PMID: 8240251 (View on PubMed)

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. doi: 10.1126/science.285.5433.1573.

Reference Type BACKGROUND
PMID: 10477522 (View on PubMed)

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

Reference Type BACKGROUND

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. doi: 10.1128/AAC.46.9.2889-2894.2002.

Reference Type BACKGROUND
PMID: 12183243 (View on PubMed)

Related Links

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http://www.malaria.org

General information on malaria at the website of the Malaria Foundation International

http://www.lambarene.org

Homepage of Medical Research Unit, Lambaréné

Other Identifiers

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06/2002/FOS-CLIN/JP006

Identifier Type: -

Identifier Source: org_study_id