NCT01002183

Brief Summary

The aim of this study is to evaluate the role of clindamycin and artesunate as possible combination partners for fosmidomycin to protect it from its susceptibility to recrudescent infections when used as monotherapy for acute Plasmodium falciparum malaria while retaining its excellent safety profile

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2009

Completed
Last Updated

September 27, 2011

Status Verified

August 1, 2010

First QC Date

October 26, 2009

Last Update Submit

September 26, 2011

Conditions

Malaria

Keywords

MalariaPlasmodium falciparumacute uncomplicated

Outcome Measures

Primary Outcomes (1)

  • Efficacy of fosmidomycin and clindamycin/artesunate when co-administered to adults with acute uncomplicated P.f. malaria.

    12 months

Secondary Outcomes (1)

  • To determine the viability and infectivity of gametocytes induced by the co-administration of fosmidomycin with clindamycin or with clindamycin plus artesunate to adult subjects with acute uncomplicated Plasmodium falciparum malaria.

    12 months

Study Arms (1)

single arm

NO INTERVENTION

Fos-clin/Arte

Drug: Fosmidomycin

Interventions

FosmidomycinDRUG

450 mg capsules, every 12 hrs for 3 days

single arm

Eligibility Criteria

Age15 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • male and female subjects aged 15 to 55 years
  • body mass index ≥ 18.5kg/M2
  • uncomplicated P falciparum malaria with acute manifestations
  • asexual parasitaemia between 500uL and 100,000uL
  • ability to tolerate oral therapy
  • able to give informed signed consent

You may not qualify if:

  • signs of severe malaria, according to WHO criteria
  • body mass index ≤ 18.5kg/M2
  • pregnancy by history or by positive urine test
  • lactation
  • mixed plasmodial infection
  • concomitant disease masking assessment of response, including diabetes,
  • uncontrolled hypertension, heart failure, hepatic dysfunction (alanine-amino transferase \>150 U/L), renal impairment (creatinine \>125umol/L or 3mg/dl)
  • haemoglobin \< 8g/dl
  • white cell count \> 12000/uL
  • anti-malarial treatment within previous 28 days
  • symptomatic AIDS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mahidol University

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

MalariaMalaria, Falciparum

Interventions

fosmidomycin

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Design

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

Study Record Dates

First Submitted

October 26, 2009

First Posted

October 27, 2009

Last Updated

September 27, 2011

Record last verified: 2010-08

Locations

TH(1)