NCT01055002

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jan 2010

Typical duration for phase_1 healthy

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

January 1, 2010

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 25, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

June 27, 2011

Status Verified

June 1, 2011

Enrollment Period

6 months

First QC Date

January 21, 2010

Last Update Submit

June 23, 2011

Conditions

HealthyNon-smokers

Keywords

Health male volunteersMale volunteers aged 18-45 yearsNon-smokers and in good health

Outcome Measures

Primary Outcomes (1)

  • Parasite clearance rates by PCR

    1-7 days after drug treatment

Secondary Outcomes (1)

  • Parasite growth rates by PCR

    1-6 days after inoculation

Study Arms (2)

Artemether/lumefantrine tablets

ACTIVE COMPARATOR

Artemether (20 mg) and Lumefantrine (120 mg) tablets: Four tablets taken as a single dose twice a day with fatty food for three days (total dose of 24 tablets in 6 doses) on days 6-8

Biological: Blood stage parasite (BSP) inoculum

Atovaquone/Proguanil HCl tablets

ACTIVE COMPARATOR

Atovaquone (250 mg) and Proguanil HCl (100 mg) tablets: Four tablets taken as a single dose daily for 3 days (total dose of 12 tablets) on days 6-8

Biological: Blood stage parasite (BSP) inoculum

Interventions

Blood stage parasite (BSP) inoculumBIOLOGICAL

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

Artemether/lumefantrine tabletsAtovaquone/Proguanil HCl tablets

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males aged 18-45 years who do not live alone
  • BMI within 18-30
  • Understand the procedures and risks involved
  • Contactable for the duration of the study
  • Non-smokers and in good health
  • Good venous access

You may not qualify if:

  • History of malaria
  • Been in a malaria-endemic country within 12 months
  • Evidence of cardiovascular risk
  • Splenectomy
  • History of severe allergic reactions after vaccination of infusion
  • Any serious chronic illness
  • Inherited genetic anomaly
  • Any volunteers wishing to donate blood to the blood bank in the future
  • Retinal or visual field changes
  • Diagnosis of chronic severe psychiatric condition
  • Hospitalisation within 5 years for psychiatric illness, suicide attempt or danger to self or others
  • Receiving psychiatric drugs (some exceptions)
  • Known QTc prolongation
  • Family history of cardiac anomalies
  • Recent or current therapy with an antibiotic or drug with potential antimalarial activity
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Q-Pharm Clinics, Royal Brisbane and Women's Hospital

Brisbane, Queensland, 4006, Australia

Location

Related Publications (1)

  • McCarthy JS, Sekuloski S, Griffin PM, Elliott S, Douglas N, Peatey C, Rockett R, O'Rourke P, Marquart L, Hermsen C, Duparc S, Mohrle J, Trenholme KR, Humberstone AJ. A pilot randomised trial of induced blood-stage Plasmodium falciparum infections in healthy volunteers for testing efficacy of new antimalarial drugs. PLoS One. 2011;6(8):e21914. doi: 10.1371/journal.pone.0021914. Epub 2011 Aug 22.

    PMID: 21887214DERIVED

Study Officials

  • James McCarthy, MD FRACP

    Queensland Institute of Medical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 21, 2010

First Posted

January 25, 2010

Study Start

January 1, 2010

Primary Completion

July 1, 2010

Study Completion

August 1, 2010

Last Updated

June 27, 2011

Record last verified: 2011-06

Locations

AU(1)