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.: PACTR201303000505764 Date of Registration: 19/02/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Impact of GneXpert MTB/RIF on TB outcomes in an ART clinic
Official scientific title Preventing TB-related adverse outcomes in patients initiating ART: the impact of Xpert MTB/RIF
Brief summary describing the background and objectives of the trial In December 2010, WHO recommended Xpert MTB/RIF as the first line TB diagnostic in HIV-infected patients. The impact of Xpert MTB/RIF on TB outcomes in patients initiating antiretroviral therapy(ART) is unknown.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS,Tuberculosis
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 25/07/2011
Actual trial start date 26/10/2011
Anticipated date of last follow up 29/06/2012
Actual Last follow-up date 19/07/2012
Anticipated target sample size (number of participants) 400
Actual target sample size (number of participants) 440
Recruitment status Completed
Publication URL http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1001760
Secondary Ids Issuing authority/Trial register
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
Parallel: different groups receive different interventions at same time during study Randomised permuted block randomisation with blocks of size four. Allocation was done in the laboratory. The code was placed in sealed opaque envelopes kept by the data manager and given to the laboratory manager in batches. The code was exposed only after specimens were assigned sequential lab numbers. Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Xpert MTB/RIF 220
Control Group Fluorescent microscopy 220
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- aged 18 years or older - HIV positive eligible for ART - on ART - on TB treatment/treated in the past 6 months - seriously ill (fever >38oC, respiratory rate >30 beats/minute and unable to walk unaided) 18 Year(s) 100 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 28/03/2011 Medical Research Council of Zimbabwe
Ethics Committee Address
Street address City Postal code Country
Josiah Tongogara/Mazoe Street Harare Zimbabwe
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Adverse outcome - delayed diagnosis: TB diagnosed 30 days after recruitment - IRIS: TB diagnosed after ART initiation - early mortality: any death within the three month period
Secondary Outcome -diagnostic yield of sputum induction At analysis
Secondary Outcome Risk factors for adverse outcome At analysis
Secondary Outcome Burden of TB in asymptomatic patients At analysis
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Beatrice Road Infectious Diseases Hospital Simon Mazorodze Road Harare 9999 Zimbabwe
FUNDING SOURCES
Name of source Street address City Postal code Country
Southern Africa Consortium for Research Excellence College of Health Sciences, University of Zimbabwe Harare Zimbabwe
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Professor Peter Mason Biomedical Research and Training Institute Harare Zimbabwe University
COLLABORATORS
Name Street address City Postal code Country
Reggie Mutetwa Biomedical Research and TrainingInstitute Harare Zimbabwe
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Lucy Mupfumi lmupfumi@gmail.com +263-4735000 4th Floor NICOZ Diamond House, Samora Machel Avenue
City Postal code Country Position/Affiliation
Harare 9999 Zimbabwe Research Fellow
Role Name Email Phone Street address
Public Enquiries Peter Mason pmason@brti.co.zw +263-4735000 4th floor NICOZ Diamond House, Samora Machel Avenue
City Postal code Country Position/Affiliation
Harare 9999 Zimbabwe Director
Role Name Email Phone Street address
Scientific Enquiries Reggie Mutetwa rmutetwa@gmail.com +263-4735000 4th Floor NICOZ Diamond House, Samora Machel Avenue
City Postal code Country Position/Affiliation
Harare 9999 Zimbabwe PhD fellow, Health Innovations Unit Coordinator
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