NCT00217451

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2002

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

September 22, 2005

Status Verified

September 1, 2005

First QC Date

September 12, 2005

Last Update Submit

September 19, 2005

Conditions

Malaria

Keywords

MalariaFosmidomycinClindamycinGabon

Outcome Measures

Primary Outcomes (2)

  • Proportion of patients cured by day 14

  • Incidence of adverse events after the start of treatment

Secondary Outcomes (3)

  • Parasite clearance time

  • Fever clearance time

  • PCR corrected day 28 cure rate

Interventions

Fosmidomycin-clindamycinDRUG

Eligibility Criteria

Age12 Months - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Research Unit, Lambaréné

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

Location

Related Publications (6)

  • 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.

    PMID: 9026BACKGROUND

  • 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.

    PMID: 9482846BACKGROUND

  • 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.

    PMID: 8240251BACKGROUND

  • 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.

    PMID: 10477522BACKGROUND

  • 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

    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.

    PMID: 12183243BACKGROUND

Related Links

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Steffen Borrmann, MD

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

    PRINCIPAL INVESTIGATOR

  • Peter G. Kremsner, MD, FRCP

    Albert Schweitzer Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 22, 2005

Study Start

June 1, 2002

Study Completion

March 1, 2003

Last Updated

September 22, 2005

Record last verified: 2005-09

Locations

GA(1)