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: pactr.samrc.ac.za
Trial no.: PACTR201107000309419 Date of Approval:
Trial Status:
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 Infections and Infestations
Sub-Disease(s) or condition(s) being studied Tuberculosis
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 07/01/2011
Actual trial start date 07/03/2011
Anticipated date of last follow up 05/03/2012
Actual Last follow-up date
Anticipated target sample size (number of participants) 1200
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum 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 Year(s) 80 Year(s) 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 Zambia Lusaka Zambia
University of Cape Town Old Main Building, Groote Schuur hospital Cape Town 7945 South Africa
Medical Research Council Durban South Africa
University of Zimbabwe Harare Zimbabwe
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
Lynn Zijenah Harare Zimbabwe
Peter Mason Harare Zimbabwe
Peter Mwaba Lusaka Zambia
Alexander Pym Durban South Africa
other members TBNEAT Consortium
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Keertan Dheda Keertan.Dheda@uct.ac.za +27214067650 H46.41 Old Main Building, Groote Schuur Hospital
City Postal code Country Position/Affiliation
Cape Town 7945 South Africa University of Cape Town
Role Name Email Phone Street address
Principal Investigator Peter Mason pmason@brti.co.zw +2634735 000
City Postal code Country Position/Affiliation
Harare Zimbabwe University of Zimbabwe
Role Name Email Phone Street address
Principal Investigator Lynn Zijenah lzijenah@gmail.com +263 479 294
City Postal code Country Position/Affiliation
Harare Zimbabwe
Role Name Email Phone Street address
Principal Investigator Alexander Pym alexander.pym@mrc.ac.za +27312034771
City Postal code Country Position/Affiliation
Durban South Africa Medical Research Council
Role Name Email Phone Street address
Principal Investigator Peter Mwaba pbmwaba2000@yahoo.com +260 211 251 499
City Postal code Country Position/Affiliation
Lusaka Zambia
Role Name Email Phone Street address
Public Enquiries Keertan Dheda keertan.dheda@uct.ac.za +27 (0) 21 406 6509 UCT Lung Infection and Immunity unit H46.41 Old Main Building, Groote Schuur Hospital
City Postal code Country Position/Affiliation
Obervatory, Cape Town 7945 South Africa Professor, UCT
Role Name Email Phone Street address
Scientific Enquiries Keertan Dheda keertan.dheda@uct.ac.za +27 (0) 21 406 6509 UCT Lung Infection and Immunity unit H46.41 Old Main Building, Groote Schuur Hospital
City Postal code Country Position/Affiliation
Cape Town 7945 South Africa Professor, UCT
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information