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Trial registered on ANZCTR
Registration number
ACTRN12613000669796
Ethics application status
Approved
Date submitted
12/06/2013
Date registered
19/06/2013
Date last updated
15/01/2015
Type of registration
Prospectively registered
Titles & IDs
Public title
An Experimental Study To Characterise the in vivo Infectivity in Humans of the in vitro Expanded Blood Stage Plasmodium Falciparum Line QIMR3D7Pf
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Scientific title
An Experimental Study To Characterise the in vivo Infectivity in Humans of the in vitro Expanded Blood Stage Plasmodium Falciparum Line QIMR3D7Pf
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Secondary ID [1]
282660
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NIL
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Universal Trial Number (UTN)
NIL
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Trial acronym
NIL
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Malaria
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Condition category
Condition code
Infection
289697
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0
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Studies of infection and infectious agents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This is a single-centre, study using blood stage malaria infected red blood cells inoculum challenge in order to characterize the infectivity of the in vitro expanded Plasmodium falciparum QIMR3D7Pf in healthy volunteers. The study will be conducted in 2 individuals. Each participant in the cohort will be inoculated on Day 0 with ~1,800 viable Plasmodium falciparum-in vitro infected human erythrocytes administered intravenously. On an outpatient basis, participants will be monitored daily prior to detection of parasites or morning (AM) and evening (PM) (once PCR positive for presence of malaria parasites) from day 3 to day 7 for adverse events and the unexpected early onset of symptoms, signs or parasitological evidence of malaria. On the day designated for commencement of treatment, as determined by qPCR results (expected to be Day 7), participants will be admitted to the study unit and confined for safety monitoring and antimalarial treatment. The threshold for commencement of treatment will be when PCR quantification is confirmed to be approximately =1,000 parasites/mL when the participants will be administered antimalarial treatment. If clinical evidence of malaria (the onset of clinical features of malaria) occurs or PCR quantification of =1,000 parasites/mL is detected before day 7 morning, allocated treatment will begin at this time. Following treatment, participants will be followed up as inpatients for at least 36 hours, to ensure tolerance of the therapy and clinical response, then if clinically well on an outpatient basis for monitoring of, safety and clearance of malaria parasites via PCR.
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Intervention code [1]
287326
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Treatment: Drugs
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Comparator / control treatment
N/A
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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To characterize the in vivo infectivity of QIMR3D7Pf in healthy volunteers, following infection with in vitro expanded blood stage P. falciparum parasites.
This outcome is assessed though regular PCR blood tests
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Assessment method [1]
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Timepoint [1]
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Timepoints day 5- day 28
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Secondary outcome [1]
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To confirm the parasite growth curves after I.V. inoculation of healthy volunteers with in vitro expanded blood stage P. falciparum strain 3D7 malaria parasites; This outcome is assessed though regular PCR blood tests
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Assessment method [1]
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Timepoint [1]
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Timepoints day 5- day 28
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Secondary outcome [2]
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To establish the parasite clearance profiles by PCR after administration of antimalarial drug at a target parasitemia of =1,000 parasites/mL after inoculation with an experimental malaria challenge; This outcome is assessed though regular PCR blood tests
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Assessment method [2]
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Timepoint [2]
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Timepoints day 5- day 28
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Secondary outcome [3]
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To assess the safety of an experimental malaria challenge using in vitro expanded blood stage parasites. This outcome is assessed though clinical assessment (history, vital signs, and physical examination), as well as urinalysis, haematology biochemistry and red cell alloantibody evaluation
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Assessment method [3]
303247
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Timepoint [3]
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Timepoint 90 DAYS
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Eligibility
Key inclusion criteria
1. Participants will be adults (males or non pregnant females), aged between 18 and 45 years who do not live alone (from Day 1 until at least the end of the antimalarial drug treatment).
2. Participants must have a BMI within the range 18–30 kg/m2.
3. Participants must understand the procedures involved and agree to participate in the study by giving fully informed, written consent.
4. Be contactable and available for the duration of the trial (maximum of 4 weeks).
5. Participants must be non-smokers and in good health, as assessed during pre-study medical examination and by review of screening results.
6. Female participants of childbearing potential, should be surgically sterile or using an insertable, injectable, transdermal, or combination oral contraceptive approved by the US FDA or TGA combined with a barrier contraceptive through completion of the study and have negative results on a serum or urine pregnancy test done before administration of study medication.
7. Good peripheral venous access.
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Minimum age
18
Years
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Maximum age
45
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1. History of malaria or tavelled to or lived (greater than 2 weeks) in a malaria-endemic country during the past 12 months
2. Has evidence of increased cardiovascular disease risk
3. History of splenectomy.
4. History of a severe allergic reaction, anaphylaxis or convulsions following any vaccination or infusion.
5. Presence of current or suspected serious chronic diseases or significant intercurrent disease of any type
6. Unwilling to defer blood donations for 6 months.
7. Recent or current therapy with an antibiotic or drug with potential antimalarial activity (tetracycline, azthromycin, clindamycin, hydroxychloroquine etc.).
8. Concomitant use of any drug which is metabolised by the cytochrome enzyme CYP2D6
9. Use of corticosteroids, anti-inflammatory drugs, any immunomodulators or anticoagulants.
10. Presence of acute infectious disease or fever
15. Evidence of acute illness within the four weeks before trial prior to screening.
11. Alcohol consumption greater than community norms (i.e. more than 21 standard drinks per week for males).
12. A history of drug habituation, or any prior intravenous usage of an illicit substance.
13. Medical requirement for intravenous immunoglobulin or blood transfusions.
14. Participation in any investigational product study within the 8 weeks preceding the study.
15. Any clinically significant biochemical or haematologic abnormality
16. Vital signs outside the reference range and clinically significant.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
Descriptive statistical analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
30/06/2013
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Actual
31/07/2013
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Date of last participant enrolment
Anticipated
30/09/2013
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Actual
21/08/2013
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
2
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
Charities/Societies/Foundations
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Name
Queensland Institute of Medical Research
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Address
300 Herston Road, Herston, Brisbane, QLD, 4006
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
286186
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Country [1]
286186
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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The Queensland Institute of Medical Research
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Ethics committee address [1]
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The Queensland Institute of Medical Research HREC,
QIMR Central, 300 Herston Road, HERSTON, QLD, 4006
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Ethics committee country [1]
289417
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Australia
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Date submitted for ethics approval [1]
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Approval date [1]
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03/05/2013
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Ethics approval number [1]
289417
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P1528
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Summary
Brief summary
This is a single-centre study using a QIMR3D7Pf innoculum challenge to assess the infectivity of this recently collected isolate. The study will be a first in human study conducted in 2 participants. A sentinel volunteer will be dosed 24 h ahead of the remaining volunteer.
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Trial website
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Trial related presentations / publications
none to date
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Public notes
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Contacts
Principal investigator
Name
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Dr James McCarthy
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Address
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Queensland Institute of Medical Research
300 Herston Rd
Herston QLD 4006
Australia
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Country
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Australia
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Phone
40718
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+61 7 33620222
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Fax
40718
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+61 7 3845 3637
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Email
40718
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[email protected]
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Contact person for public queries
Name
40719
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Dr Silvana Sekuloski
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Address
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Queensland Institute of Medical Research
300 Herston Rd
Herston QLD 4006
Australia
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Country
40719
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Australia
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Phone
40719
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+61 7 38453856
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Fax
40719
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+61 7 38453507
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Email
40719
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[email protected]
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Contact person for scientific queries
Name
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Dr James McCarthy
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Address
40720
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Queensland Institute of Medical Research
300 Herston Rd
Herston QLD 4006
Australia
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Country
40720
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Australia
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Phone
40720
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+61 7 33620222
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Fax
40720
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+61 7 3845 3637
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Email
40720
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[email protected]
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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
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Dimensions AI
Infectivity of Plasmodium falciparum in Malaria-Naive Individuals Is Related to Knob Expression and Cytoadherence of the Parasite
2016
https://doi.org/10.1128/iai.00414-16
N.B. These documents automatically identified may not have been verified by the study sponsor.
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