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Efficacy of Fosmidomycin-Clindamycin for Treating Malaria in Gabonese Children

Primary Purpose

Malaria

Status

Completed

Phase

Phase 3

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, Chemotherapy, Gabon

Eligibility Criteria

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

Inclusion Criteria: Uncomplicated P. falciparum malaria P. falciparum asexual parasitaemia between 1,000/µL and 100,000/µL Body weight between 10 - 65 kg Ability to tolerate oral therapy Informed consent, oral assent of the child, if possible Residence in study area Exclusion Criteria: Adequate anti-malarial treatment within the previous 7 days Antibiotic treatment for the current infection Previous participation in this clinical trial Haemoglobin < 7 g/dl Haematocrit < 23 % Leucocyte count > 15,000 /µL Mixed plasmodial infection Severe malaria (as defined by WHO) Any other severe underlying disease (cardiac, renal, hepatic diseases, malnutrition, known HIV infection) Concomitant disease masking assessment of response History of allergy or intolerance against trial medication

Sites / Locations

Medical Research Unit, Lambaréné

Outcomes

Primary Outcome Measures

Clinical and parasitological cure rate by day 28

Secondary Outcome Measures

Safety and tolerability of the two treatments during the entire study period

Parasite clearance time

Fever clearance time

Full Information

NCT ID

NCT00214643

First Posted

September 11, 2005

Last Updated

February 3, 2009

Sponsor

Albert Schweitzer Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00214643

Brief Title

Efficacy of Fosmidomycin-Clindamycin for Treating Malaria in Gabonese Children

Official Title

A Comparative Assessment of the Efficacy of Fosmidomycin-Clindamycin Versus Sulfadoxine-Pyrimethamine for the Treatment of Children With Uncomplicated Plasmodium Falciparum Malaria

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Completed

Study Start Date

June 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

July 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Albert Schweitzer Hospital

4. Oversight

5. Study Description

Brief Summary

There is a necessity for the development of new malaria drugs. 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. Previous small studies have shown that in combination with clindamycin, an commonly used antibiotic, it is highly effective and safe when given for three days, leading to a total cure in most patients. The current study will evaluate its efficacy in a larger population in Gabon, and compare its effect with the generally used drug, sulfadoxine-pyrimethamine.

Detailed Description

Fosmidomycin-clindamycin (30 mg/kg and 10 mg/kg) given twice daily for three days is an effective and safe combination of antibiotics which demonstrated good activity against malaria parasite in previous phase II studies in African children. In this phase III trial, the efficacy and safety of the combination will be evaluated in African children with uncomplicated P. falciparum malaria. A single dose of sulfadoxine-pyrimethamine, the standard antimalarial in Gabon, is used as comparator.

6. Conditions and Keywords

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

Malaria

Keywords

Malaria, Fosmidomycin, Clindamycin, Chemotherapy, Gabon

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

160 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Fosmidomycin

Intervention Description

30 mg/kg

Intervention Type

Drug

Intervention Name(s)

clindamycin

Intervention Description

10 mg/kg

Primary Outcome Measure Information:

Title

Clinical and parasitological cure rate by day 28

Secondary Outcome Measure Information:

Title

Safety and tolerability of the two treatments during the entire study period

Title

Parasite clearance time

Title

Fever clearance time

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

14 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Saadou Issifou, MD

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

4066076

Citation

Kuemmerle HP, Murakawa T, Sakamoto H, Sato N, Konishi T, De Santis F. Fosmidomycin, a new phosphonic acid antibiotic. Part II: 1. Human pharmacokinetics. 2. Preliminary early phase IIa clinical studies. Int J Clin Pharmacol Ther Toxicol. 1985 Oct;23(10):521-8.

Results Reference

background

PubMed Identifier

4066075

Citation

Kuemmerle HP, Murakawa T, Soneoka K, Konishi T. Fosmidomycin: a new phosphonic acid antibiotic. Part I: Phase I tolerance studies. Int J Clin Pharmacol Ther Toxicol. 1985 Oct;23(10):515-20.

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

Citation

Kuzuyama T, Shizimu T, Takashi S and Seto H. Fosmidomycin, a specific inhibitor of 1-deoxy-D-xylulose 5-phosphate reductoisomerase in the nonmevalonate pathway of isoprenoid biosynthesis. Tetrahaedron Lett 1998;39:7913-6

Results Reference

background

Citation

Zeidler J, Schwender J, Müller C, et al. Inhibition of the non-mevalonate 1-deoxy-D-xylulose-5-phosphate pathway of plant isoprenoid biosynthesis by fosmidomycin. Z Naturforsch 1998;53:980-6

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

9707569

Citation

Takahashi S, Kuzuyama T, Watanabe H, Seto H. A 1-deoxy-D-xylulose 5-phosphate reductoisomerase catalyzing the formation of 2-C-methyl-D-erythritol 4-phosphate in an alternative nonmevalonate pathway for terpenoid biosynthesis. Proc Natl Acad Sci U S A. 1998 Aug 18;95(17):9879-84. doi: 10.1073/pnas.95.17.9879.

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

PubMed Identifier

9045615

Citation

Kohler S, Delwiche CF, Denny PW, Tilney LG, Webster P, Wilson RJ, Palmer JD, Roos DS. A plastid of probable green algal origin in Apicomplexan parasites. Science. 1997 Mar 7;275(5305):1485-9. doi: 10.1126/science.275.5305.1485.

Results Reference

background

PubMed Identifier

9389481

Citation

Fichera ME, Roos DS. A plastid organelle as a drug target in apicomplexan parasites. Nature. 1997 Nov 27;390(6658):407-9. doi: 10.1038/37132.

Results Reference

background

PubMed Identifier

14976608

Citation

Borrmann S, Adegnika AA, Matsiegui PB, Issifou S, Schindler A, Mawili-Mboumba DP, Baranek T, Wiesner J, Jomaa H, Kremsner PG. Fosmidomycin-clindamycin for Plasmodium falciparum Infections in African children. J Infect Dis. 2004 Mar 1;189(5):901-8. doi: 10.1086/381785. Epub 2004 Feb 16.

Results Reference

background

PubMed Identifier

15478056

Citation

Borrmann S, Issifou S, Esser G, Adegnika AA, Ramharter M, Matsiegui PB, Oyakhirome S, Mawili-Mboumba DP, Missinou MA, Kun JF, Jomaa H, Kremsner PG. Fosmidomycin-clindamycin for the treatment of Plasmodium falciparum malaria. J Infect Dis. 2004 Nov 1;190(9):1534-40. doi: 10.1086/424603. Epub 2004 Sep 21.

Results Reference

background

PubMed Identifier

10030329

Citation

Shulman CE, Dorman EK, Cutts F, Kawuondo K, Bulmer JN, Peshu N, Marsh K. Intermittent sulphadoxine-pyrimethamine to prevent severe anaemia secondary to malaria in pregnancy: a randomised placebo-controlled trial. Lancet. 1999 Feb 20;353(9153):632-6. doi: 10.1016/s0140-6736(98)07318-8.

Results Reference

background

PubMed Identifier

11377597

Citation

Schellenberg D, Menendez C, Kahigwa E, Aponte J, Vidal J, Tanner M, Mshinda H, Alonso P. Intermittent treatment for malaria and anaemia control at time of routine vaccinations in Tanzanian infants: a randomised, placebo-controlled trial. Lancet. 2001 May 12;357(9267):1471-7. doi: 10.1016/S0140-6736(00)04643-2.

Results Reference

background

PubMed Identifier

11103309

Citation

Severe falciparum malaria. World Health Organization, Communicable Diseases Cluster. Trans R Soc Trop Med Hyg. 2000 Apr;94 Suppl 1:S1-90. No abstract available.

Results Reference

background

Links:

URL

http://www.malaria.org

Description

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

URL

http://www.lambarene.org

Description

Homepage of the Medical Research Unit, Lambaréné

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Efficacy of Fosmidomycin-Clindamycin for Treating Malaria in Gabonese Children

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