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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01055002




Registration number
NCT01055002
Ethics application status
Date submitted
21/01/2010
Date registered
25/01/2010
Date last updated
27/06/2011

Titles & IDs
Public title
A Pilot Study to Test Activity of Antimalarial Drugs Against an Induced Malaria Infection in Healthy Volunteers
Scientific title
A Pilot Phase II Study of the Efficacy of Antimalarial Drugs Against Plasmodium Falciparum by Experimental Challenge With a Low Dose of Blood Stage Parasites in Healthy Male Volunteers
Secondary ID [1] 0 0
QP09C08
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Non-smokers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Blood stage parasite (BSP) inoculum

Active comparator: Artemether/lumefantrine tablets - 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

Active comparator: Atovaquone/Proguanil HCl tablets - 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


Treatment: Other: Blood stage parasite (BSP) inoculum
Inoculum of human red blood cells infected with falciparum malaria administered intravenously on Day 1
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Parasite clearance rates by PCR
Timepoint [1] 0 0
1-7 days after drug treatment
Secondary outcome [1] 0 0
Parasite growth rates by PCR
Timepoint [1] 0 0
1-6 days after inoculation

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
* 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
* Known hypersensitivity to artemether or lumefantrine, atovaquone or proguanil hydrochloride or any of the excipients
* Concomitant use of any drug which is metabolised by the cytochrome enzyme CYP2D6 OR drugs that are known to prolong the QTc interval
* Use of corticosteroids, anti-inflammatory drugs, any immunomodulators or anticoagulants. Currently receiving or have previously received immunosuppressive therapy, including systemic steroids including ACTH or inhaled steroids in dosages which are associated with hypothalamicpituitary- adrenal axis suppression such as 1mg/kg/day of prednisone or its equivalent or chronic use of inhaled high potency corticosteroids
* Presence of acute infectious disease or fever
* Evidence of acute illness within the four weeks before trial prior to screening
* Significant intercurrent disease of any type, in particular liver, renal, cardiac, pulmonary, neurologic, rheumatologic, or autoimmune disease by history, physical examination, and/or laboratory studies including urinalysis
* Alcohol consumption greater than community norms
* A history of drug habituation, or any prior intravenous usage of an illicit substance
* Medical requirement for intravenous immunoglobulin or blood transfusions
* Participation in any investigational product study within the 8 weeks preceding the study
* Participation in any research study involving significant blood sampling, or blood donation to a blood bank during the 8 weeks preceding the study
* Have ever received a blood transfusion
* Positive test for HIV, Hepatitis B, hepatitis C, Human T-cell Lymphotropic Virus I & II (HTLVI & HTLVII), and syphilis
* Any clinically significant biochemical or haematologic abnormality (Hb must be =13.5g/dL)
* Ingestion of any poppy seeds within the 48 hours prior to the screening blood test
* Detection of any recreational drug listed in the urine drug screen

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2010
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Q-Pharm Clinics, Royal Brisbane and Women's Hospital - Brisbane
Recruitment postcode(s) [1] 0 0
4006 - Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
Medicines for Malaria Venture
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Queensland Institute of Medical Research
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Q-Pharm Pty Limited
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/industry
Name [3] 0 0
Trident Clinical Research Pty Ltd
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
James McCarthy, MD FRACP
Address 0 0
Queensland Institute of Medical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01055002