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Treatment of Malaria in Gabon With Fosmidomycin-Clindamycin

Primary Purpose

Malaria

Status

Completed

Phase

Phase 2

Locations

Gabon

Study Type

Interventional

Intervention

Fosmidomycin-clindamycin

About this trial

This is an interventional treatment trial for Malaria focused on measuring Malaria, Fosmidomycin, Clindamycin, Gabon

Eligibility Criteria

12 Months - 14 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Medical Research Unit, Lambaréné

Outcomes

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

Full Information

NCT ID

NCT00217451

First Posted

September 12, 2005

Last Updated

September 19, 2005

Sponsor

Albert Schweitzer Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00217451

Brief Title

Treatment of Malaria in Gabon With Fosmidomycin-Clindamycin

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Completed

Study Start Date

June 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

March 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Albert Schweitzer Hospital

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malaria

Keywords

Malaria, Fosmidomycin, Clindamycin, Gabon

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

51 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Fosmidomycin-clindamycin

Primary Outcome Measure Information:

Title

Proportion of patients cured by day 14

Title

Incidence of adverse events after the start of treatment

Secondary Outcome Measure Information:

Title

Parasite clearance time

Title

Fever clearance time

Title

PCR corrected day 28 cure rate

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Months

Maximum Age & Unit of Time

14 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steffen Borrmann, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Peter G. Kremsner, MD, FRCP

Organizational Affiliation

Albert Schweitzer Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical Research Unit, Lambaréné

City

Lambaréné

State/Province

Moyen Ogooué

ZIP/Postal Code

B.P. 118

Country

Gabon

12. IPD Sharing Statement

Citations:

PubMed Identifier

9026

Citation

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.

Results Reference

background

PubMed Identifier

9482846

Citation

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.

Results Reference

background

PubMed Identifier

8240251

Citation

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.

Results Reference

background

PubMed Identifier

10477522

Citation

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.

Results Reference

background

Citation

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

Results Reference

background

PubMed Identifier

12183243

Citation

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.

Results Reference

background

Links:

URL

http://www.malaria.org

Description

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

URL

http://www.lambarene.org

Description

Homepage of Medical Research Unit, Lambaréné

Learn more about this trial

Treatment of Malaria in Gabon With Fosmidomycin-Clindamycin

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