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Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834     Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za     Website: www.pactr.org

Trial no.: PACTR201107000309419 Date registered: 2011/07/07
TRIAL DESCRIPTION
Public title TBNEATXpertRCT
Official scientific title TBNEAT Xpert MTB/RIF point-of-treatment (POT) randomised control trial (RCT)
Brief summary describing the background
and objectives of the trial
Xpert MTB/RIF assay is a novel automated molecular tool for the diagnosis of TB. There is limited data on the impact of Xpert on time-to-treatment and TB-related patient morbidity in primary care clinics. No studies have evaluated POT Xpert. Our study objectives are to assess the feasibility and impact of a single sputum Xpert, performed at the POT, to improve time-to-diagnosis, time-to-treatment and TB-related patient morbidity in a primary care high HIV TB prevalence settings.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) TBNEATXpertRCT
Disease(s) or condition(s) being studied Tuberculosis ,
Purpose of the trial Diagnosis
Anticipated trial start date 2011-01-07
Actual trial start date 2011-03-07
Anticipated date of last follow up 2012-03-05
Actual date of last follow up
Anticipated target sample size (number of participants) 1200   
Actual target sample size (number of participants)   
Recruitment status Open to recruitment: actively recruiting participants
Secondary Ids Issuing authority/Trial register Links to Secondary ID
IP.09.32040.009 EDCTP

STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person
allocating the participants to the intervention arms
Masking If masking / blinding was used
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 Open-label (masking not used)

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental group Xpert MTB/RIF assay single automated nucleic-acid amplification test for Mtb 600
Control group Smear micrsocopy 2 same day smears sputum smear microscopy for TB diagnosis 600 Active

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
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 > 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: 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 18 Years 80 Years Both

ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval
Name of the ethics committee
Yes University of Cape Town, Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
E56 Old Main Building, Groote Schuur Hospital Cape Town 7945 South Africa

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Time-to-initiation of treatment exact number of days will be documented up till 6 months after enrollment
Primary Outcome Mean difference in TB score at 2 and 6 months follow-up Baseline 2 months 6 months
Secondary Outcome Time-to-diagnosis Up to 6 months
Secondary Outcome Drop-out and lost-to-follow up rates Up to 6 months post enrollment
Secondary Outcome Feasibility of clinic-based performance of Xpert MTB/RIF assay performed by nursing staff without formal research training Up to 6 months after enrollment
Secondary Outcome Individual patient-level cost analysis, cost-effectiveness evaluation and quality of health indices evaluation Baseline 2 month 6 month

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Zimbabwe Harare Zimbabwe
University of Zambia Lusaka Zambia
University of Cape Town Old Main Building, Groote Schuur hospital Cape Town 7945 South Africa
Medical Research Council Durban South Africa

FUNDING SOURCES
Name of source Street address City Postal code Country
EDCTP P.O. Box 93015 The Hague 2509A Netherlands

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Greg Hussey H46.41 Old Main Building, Groote Schuur Hospital, Observatory Cape Town 7945 South Africa University

COLLABORATORS
Name Street address City Postal code Country
Peter Mwaba Lusaka Zambia
Lynn Zijenah Harare Zimbabwe
Peter Mason Harare Zimbabwe
Alexander Pym Durban South Africa
other members TBNEAT Consortium

CONTACT PEOPLE
Role Name Email Phone Fax
Public Enquiries Prof Keertan Dheda keertan.dheda@uct.ac.za +27 (0) 21 406 6509 +27 (0) 21 448 6815
Street address City Postal code Country Position / Affiliation
UCT Lung Infection and Immunity unit H46.41 Old Main Building, Groote Schuur Hospital Obervatory, Cape Town 7945 South Africa Professor, UCT
Role Name Email Phone Fax
Scientific Enquiries Prof Keertan Dheda keertan.dheda@uct.ac.za +27 (0) 21 406 6509 +27 (0) 21 448 6815
Street address City Postal code Country Position / Affiliation
UCT Lung Infection and Immunity unit H46.41 Old Main Building, Groote Schuur Hospital Cape Town 7945 South Africa Professor, UCT
Role Name Email Phone Fax
Principal Investigator Prof Lynn Zijenah lzijenah@gmail.com +263 479 294
Street address City Postal code Country Position / Affiliation
Harare Zimbabwe
Role Name Email Phone Fax
Principal Investigator Dr Keertan Dheda Keertan.Dheda@uct.ac.za +27214067650 +27214047650
Street address City Postal code Country Position / Affiliation
H46.41 Old Main Building, Groote Schuur Hospital Cape Town 7945 South Africa University of Cape Town
Role Name Email Phone Fax
Principal Investigator Prof Peter Mason pmason@brti.co.zw +2634735 000
Street address City Postal code Country Position / Affiliation
Harare Zimbabwe University of Zimbabwe
Role Name Email Phone Fax
Principal Investigator Dr Alexander Pym alexander.pym@mrc.ac.za +27312034771
Street address City Postal code Country Position / Affiliation
Durban South Africa Medical Research Council
Role Name Email Phone Fax
Principal Investigator Dr Peter Mwaba pbmwaba2000@yahoo.com +260 211 251 499
Street address City Postal code Country Position / Affiliation
Lusaka Zambia