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Trial registered on ANZCTR
Registration number
ACTRN12619001439134
Ethics application status
Approved
Date submitted
18/09/2019
Date registered
17/10/2019
Date last updated
22/10/2021
Date data sharing statement initially provided
17/10/2019
Date results information initially provided
22/10/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
A pilot study for universal testing and treatment of Latent Tuberculosis Infection (LTBI)
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Scientific title
A pilot study for universal testing and treatment of LTBI
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Secondary ID [1]
298300
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
ACT5
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Latent Tuberculosis Infection
312929
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Condition category
Condition code
Respiratory
311420
311420
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0
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Other respiratory disorders / diseases
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Infection
312921
312921
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0
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The initial treatment regimen will be 4RIF as this is currently approved and available. When 3HP is approved and available, we will switch to that regimen.
RIF regimen: 18 weeks of oral treatment with rifampicin (600mg/day for > 50 kg or 400mg/day < 50 kg body weight) as a single daily dose dispensed weekly at the participants home by a study team member.
If during the pilot study we receive approval for the use of a new treatment regimen we will commence new participants on this regimen.
3HP regimen: 12 weeks of oral treatment administered once a week with isoniazid (15mg/kg, with 900mg maximum dose) and rifapentine (900mg if greater than or equal to 50Kg, otherwise 15mg/kg if aged > 12 years)
Screening for LTBI will be performed as the part if the study. Screening involves implementation of an tuberculin skin test (TST) using the Mantoux technique. The TST is performed by injecting a small amount of tuberculin under the skin on the participants forearm. 48-72 hours after injection the test site is checked and the size of any lump will determine whether the test is positive or negative.
Participants who do not have a positive TST will not be offered any LTBI treatment. However, if they have symptoms of TB, they will be screened for TB disease.
TEST phase
Screening for LTBI infection
TREAT phase
Treatment of LTBI in those who screen positive for LTBI.
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Intervention code [1]
314533
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Treatment: Drugs
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
320139
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Proportion of eligible patients who complete at least 80% of doses of the required treatment, via record of drug delivery (directly observed therapy)
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Assessment method [1]
320139
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Timepoint [1]
320139
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18 weeks from treatment initiation for RIF regimen and 12 weeks from treatment initiation for 3HP regimen
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Secondary outcome [1]
370673
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Proportion of the census population that meet the eligibility criteria (for the screening phase)
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Assessment method [1]
370673
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Timepoint [1]
370673
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At completion of screening phase
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Secondary outcome [2]
370674
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The proportion of the eligible population in whom "Informed consent"" is obtained to participate in the study
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Assessment method [2]
370674
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Timepoint [2]
370674
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At completion of screening phase
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Secondary outcome [3]
370675
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The proportion of the eligible population in whom data on TB symptoms are acquired
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Assessment method [3]
370675
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Timepoint [3]
370675
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At completion of screening phase
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Secondary outcome [4]
370676
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The proportion of the eligible population in whom a TB skin test is placed
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Assessment method [4]
370676
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Timepoint [4]
370676
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At completion of the screening phase
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Secondary outcome [5]
370677
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The proportion of the eligible population in whom a TB skin test is read
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Assessment method [5]
370677
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Timepoint [5]
370677
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At completion of screening phase
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Secondary outcome [6]
370678
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The proportion of persons with a positive test for LTBI in whom screening for active TB disease is completed
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Assessment method [6]
370678
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Timepoint [6]
370678
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At completion of screening phase
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Secondary outcome [7]
370679
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The proportion of persons, who are eligible for treatment for LBTI, who provide consent to commence treatment
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Assessment method [7]
370679
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Timepoint [7]
370679
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At completion of the study
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Secondary outcome [8]
370680
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The proportion of persons, who are eligible for treatment for LBTI, who ingest at least one dose of treatment under observation
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Assessment method [8]
370680
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Timepoint [8]
370680
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At completion of the study
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Secondary outcome [9]
370681
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The proportion of persons, who are eligible for treatment for LBTI, who complete treatment
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Assessment method [9]
370681
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Timepoint [9]
370681
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At completion of study
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Secondary outcome [10]
370683
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The proportion of persons, who are eligible for treatment for LBTI, who were asked by the investigators to prematurely permanently discontinued treatment
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Assessment method [10]
370683
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Timepoint [10]
370683
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At completion of the study
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Secondary outcome [11]
370684
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The proportion of persons, who are eligible for treatment for LBTI, who permanently discontinue treatment prior to completion, without being asked to do so by the investigators
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Assessment method [11]
370684
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Timepoint [11]
370684
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At completion of the study
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Secondary outcome [12]
370685
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The proportion of persons, who are eligible for treatment for LBTI, who report Grade 3 or 4 adverse reactions. Information on adverse events will be acquired from a) pre-treatment symptom questionnaire; b) scheduled liver function tests and full blood count in individuals stratified as being at high risk; c) reports from patients or their carers or medical attendants.
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Assessment method [12]
370685
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Timepoint [12]
370685
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Participants followed up for adverse events for 18 weeks from treatment initiation for RIF regimen and 12 weeks from treatment initiation for 3HP regimen
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Eligibility
Key inclusion criteria
Resident in any of three selected Aps in Ca Mau Province, Vietnam
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Minimum age
15
Years
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Maximum age
No limit
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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
Exclusion criteria for the TEST phase;
No exclusion criteria for the test phase.
Exclusion criteria for the TREAT phase;
* Pregnant women or women planning and attempting to fall pregnant
* Active TB
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Study design
Purpose of the study
Prevention
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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 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/11/2019
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Actual
12/06/2020
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Date of last participant enrolment
Anticipated
1/05/2020
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Actual
31/12/2020
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Date of last data collection
Anticipated
1/08/2020
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Actual
15/06/2021
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Sample size
Target
3240
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Accrual to date
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Final
2834
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Recruitment outside Australia
Country [1]
21516
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Viet Nam
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State/province [1]
21516
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Ca Mau
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Funding & Sponsors
Funding source category [1]
302842
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Government body
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Name [1]
302842
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National Health and Medical Research Council
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Address [1]
302842
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Level 1
16 MARCUS CLARKE STREET,
Canberra, Australian Capital Territory, 2601
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Country [1]
302842
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Australia
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Primary sponsor type
Charities/Societies/Foundations
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Name
Woolcock Institute of Medical Research
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Address
431 Glebe Point Road,
Glebe, NSW, 2037
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Country
Australia
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Secondary sponsor category [1]
302790
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None
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Name [1]
302790
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Address [1]
302790
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Country [1]
302790
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
303420
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The University of Sydney, Human Research Ethics Committee
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Ethics committee address [1]
303420
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Research integrity and ethics
The University of Sydney
NSW 2006
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Ethics committee country [1]
303420
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Australia
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Date submitted for ethics approval [1]
303420
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31/05/2019
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Approval date [1]
303420
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16/07/2019
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Ethics approval number [1]
303420
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2019/515
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Summary
Brief summary
This study is a pilot study for a proposed community-based cluster-randomised controlled trial of universal testing and treatment for latent TB infection, together with active case finding for TB disease, to reduce the prevalence of TB. The aim of this pilot study is to develop the detailed procedures for implementing the universal testing for, and treatment of, LTBI infection and to demonstrate the feasibility, safety and acceptability in preparation for the RCT.
The study will be conducted in three Aps (sub-communes) in South Vietnam. All community members will be screened for LTBI infection and those who have evidence of LTBI will be offered drug treatment. The primary outcome will be the proportion of eligible participants with LTBI who completed at least 80% of the scheduled doses of drug treatment. Secondary outcomes include indices of participation and acceptability of the intervention.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
93618
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Prof Guy Marks
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Address
93618
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Woolcock Institute of Medical Research,
Box M77 Missenden Road Post Office
Camperdown, NSW, 2050
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Country
93618
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Australia
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Phone
93618
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+61419251565
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Fax
93618
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+61 2 9114 0011
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Email
93618
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[email protected]
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Contact person for public queries
Name
93619
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Prof Guy Marks
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Address
93619
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Woolcock Institute of Medical Research,
Box M77 Missenden Road Post Office
Camperdown, NSW, 2050
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Country
93619
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Australia
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Phone
93619
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+61419251565
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Fax
93619
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+61 2 9114 0011
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Email
93619
0
[email protected]
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Contact person for scientific queries
Name
93620
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Prof Guy Marks
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Address
93620
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Woolcock Institute of Medical Research,
Box M77 Missenden Road Post Office
Camperdown, NSW, 2050
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Country
93620
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Australia
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Phone
93620
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+61419251565
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Fax
93620
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+61 2 9114 0011
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Email
93620
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
4716
Study protocol
377640-(Uploaded-11-09-2019-15-25-10)-Study-related document.docx
4717
Informed consent form
This informed consent form is for the TEST phase o...
[
More Details
]
377640-(Uploaded-11-09-2019-15-23-58)-Study-related document.docx
4718
Informed consent form
This informed consent form is for the TREAT phase ...
[
More Details
]
377640-(Uploaded-11-09-2019-15-24-34)-Study-related document.docx
4719
Ethical approval
377640-(Uploaded-11-09-2019-15-27-28)-Study-related document.pdf
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF