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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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PACTR |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
PACTR201107000309419 |
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Date of registration:
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07/07/2011 |
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Primary sponsor: |
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Public title:
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TBNEATXpertRCT
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Scientific title:
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TBNEAT Xpert MTB/RIF point-of-treatment (POT) randomised control trial (RCT) |
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Date of first enrolment:
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2011-03-07 |
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Target sample size:
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1200 |
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Recruitment status: |
Open to recruitment: actively recruiting participa |
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URL:
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HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201107000309419 |
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Study type:
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interventional |
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Study design:
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Factorial: participants randomly allocated to either no,one,some or all interventions simultaneously,
Randomised,
simple randomisation using a randomisation table created by a computer software program,
Central randomisation by phone/fax,
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Countries of recruitment
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South Africa
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Contacts
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Name:
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Keertan
Dheda |
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Address:
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UCT Lung Infection and Immunity unit H46.41 Old Main Building, Groote Schuur Hospital
7945
Cape Town
South Africa |
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Telephone:
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+27 (0) 21 406 6509 |
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Email:
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keertan.dheda@uct.ac.za |
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Affiliation:
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Professor, UCT |
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Name:
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Keertan
Dheda |
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Address:
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UCT Lung Infection and Immunity unit H46.41 Old Main Building, Groote Schuur Hospital
7945
Obervatory, Cape Town
South Africa |
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Telephone:
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+27 (0) 21 406 6509 |
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Email:
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keertan.dheda@uct.ac.za |
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Affiliation:
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Professor, UCT |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Able and willing to give informed consent
2.
Ambulant patient presenting to TB clinic
IF HIV negative requires 2 or more of the following:
* Cough ? 2 weeks
* loss of weight
* persistent fever ? 2 weeks and/or
* a single recorded temp b 38?C
* night sweats
* generalized fatigue
* hemoptysis or
* chest pain
OR if HIV positive - any one of the following:
* current cough
* night sweats
* fever
* loss of weight
3. Patient 18 years or above
Exclusion criteria: Exclusion Criteria:
1. Inability to provide informed consent (e.g. mentally impaired)
2. Unable to produce 2 sputa of ? 1ml
3. TB treatment within the last 60 days
4. Unable to potentially return for study follow-up at 2 and 6 months (i.e. leaving community)
5. Patient not meeting inclusion criteria
Age minimum:
18 Year
Age maximum:
80 Year
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Tuberculosis
null
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Primary Outcome(s)
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Mean difference in TB score at 2 and 6 months follow-up
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Time-to-initiation of treatment
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Secondary Outcome(s)
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Drop-out and lost-to-follow up rates
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Feasibility of clinic-based performance of Xpert MTB/RIF assay performed by nursing staff without formal research training
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Individual patient-level cost analysis, cost-effectiveness evaluation and quality of health indices evaluation
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Time-to-diagnosis
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Secondary ID(s)
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IP.09.32040.009
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Source(s) of Monetary Support
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EDCTP
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