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A Pilot Study to Test Activity of Antimalarial Drugs Against an Induced Malaria Infection in Healthy Volunteers

NCT01055002 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2011-06-27

No results posted yet for this study

Summary

This is a pilot study of a protocol for inducing a falciparum malaria infection in healthy volunteers in order to test the activity of novel agents being developed as drugs for the treatment of uncomplicated malaria. In this pilot study, 16 healthy male volunteers will be administered a low level malaria infection via infected human red blood cells. After 6 days they will be administered one of two registered antimalarial treatments (8 volunteers for each treatment) in order to define the rate of clearance of the infection. This information will be used to design similar future studies for the initial assessment of the efficacy of novel antimalarial drugs in development.

Conditions

  • Healthy
  • Non-smokers

Interventions

BIOLOGICAL

Blood stage parasite (BSP) inoculum

Inoculum of human red blood cells infected with falciparum malaria administered intravenously on Day 1

Sponsors & Collaborators

  • Queensland Institute of Medical Research

    collaborator OTHER

  • Q-Pharm Pty Limited

    collaborator INDUSTRY

  • Trident Clinical Research Pty Ltd

    collaborator INDUSTRY

  • Medicines for Malaria Venture

    lead OTHER

Principal Investigators

  • James McCarthy, MD FRACP · Queensland Institute of Medical Research

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-07-31
Completion
2010-08-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01055002 on ClinicalTrials.gov