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.: PACTR201106000288379 Date of Approval: 12/04/2011
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title "Bridging the gap". Evaluating new rapid diagnostic tests for Mycobacterium tuberculosis (MTB) disease
Official scientific title Preventing adverse outcomes in smear negative TB suspects in the era of collaborative TB and HIV programmes: the contribution of new TB diagnostics
Brief summary describing the background and objectives of the trial TB control suffers from lack of rapid and sensitive diagnostic tests for TB. Smear microscopy is the most available TB tests and suffers from poor sensitivity and chest radiography with clinical management suffer from both lack of specificity and sensitivity markedly in people living with HIV. This trial is evaluating the impact of introducing sensitive Genexpert molecular TB testing as a second line test on adverse outcomes in smear negative TB patients and on programatic TB control outcomes.
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 07/04/2011
Actual trial start date 07/04/2011
Anticipated date of last follow up 14/11/2011
Actual Last follow-up date 14/11/2011
Anticipated target sample size (number of participants) 496
Actual target sample size (number of participants) 766
Recruitment status Not yet recruiting
Publication URL
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Block randomization using a computer software program The randomization list was generated on lab ID numbers for sputum specimens. received specimens are allocated lab IDs and the technologist processing specimens is given the randomization list after allocating specimen IDs Masking/blinding used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Block randomization using a computer software program The randomization list was generated on lab ID numbers for sputum specimens. received specimens are allocated lab IDs and the technologist processing specimens is given the randomization list after allocating specimen IDs Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group second line TB testing with Genexpert test single test 3 months Smear negative TB suspects from primary care health clinics tested for TB with single GeneXpert test. GeneXpert positive patients referred for TB treatment initiation. Genexpert negative smear negative TB suspects referred back to routine health services for continued TB investigations 383 Active-Treatment of Control Group
Control Group Second line fluorescent microscopy in smear negative TB suspects single test 1 day Spot sputum specimens will be collected from smear negative TB suspects randomized to the control group will be tested with direct fluorescence microscopy. Participants with smear positive results will be referred for TB treatment. Smear negative participants will be asked to continue with their routine TB investigations and followed up at 2 months 383 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria for the trial: ¿ TB suspect with cough for 2 or more weeks; ¿ Age 16 years or above; ¿ Usual residence within catchment area for local clinic; ¿ Able and willing to participate in answering questions, and providing sputum and blood specimen for storage and HIV testing; ¿ Willing to consent to study follow-up at 3 months, with a home visit if necessary; ¿ Able and willing to provide informed written consent. ¿ Age 15 years or younger ¿ Usual residence anywhere other than in catchment area of local clinic ¿ Unable to unwilling to answer questions ¿ Unable or unwilling to provide written informed consent or samples 18 Year(s) 99 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 03/06/2010 Medical Research Council of Zimbabwe
Ethics Committee Address
Street address City Postal code Country
Cnr Josiah Tongogara and Mazowe str Harare 00000 Zimbabwe
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Risk for adverse events (death, IRIS and delayed TB diagnosis) 60 days
Secondary Outcome Time to treatment initiation 60 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Budiriro primary health clinic Budiriro, Harare 00000 Zimbabwe
Highfields clinic Harare 000 Zimbabwe
Dzivarasekwa Clinic Dzivarasekwa, Harare 00000 Zimbabwe
Kuwadzana clinic Harare 00000 Zimbabwe
Kambuzuma clinic Harare 0000 Zimbabwe
Mbare primary health clinic Mbare, Harare 00000 Zimbabwe
FUNDING SOURCES
Name of source Street address City Postal code Country
Clinical Infectious Disease Research Initiative, University of Capetown Room 3.03.5, Wolfson Pavilion, IIDMM, Faculty of Health Sciences, University of Cape Town Capetown 00000 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Peter Robert Mason 4th floor Nicoz Diamond House, cnr Samora Machel and Park street Harare P.O. Box CY1753 Zimbabwe Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Elizabeth Corbett Malawi Liverpool Welcome Trust Clinical research program Blantyre 00000 Malawi
Mark Nicol Room 3.03.5, Wolfson Pavilion, IIDMM, Faculty of Health Sciences, University of Cape Town Capetown 00000 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Reggie Mutetwa rmutetwa@gmail.com 002634735000/2 4th Floor Nicoz Diamond House cnr Samora Machel and park street
City Postal code Country Position/Affiliation
Harare 00000 Zimbabwe Researcher
Role Name Email Phone Street address
Public Enquiries Lucy Mupfumi lmupfumi@gmail.com 002634735000/2 4th Floor Nicoz Diamond House cnr Samora Machel and park street
City Postal code Country Position/Affiliation
Harare 00000 Zimbabwe researcher
Role Name Email Phone Street address
Scientific Enquiries Reggie Mutetwa rmutetwa@gmail.com 002634735000/2 4th Floor Nicoz Diamond House cnr Samora Machel and park street
City Postal code Country Position/Affiliation
harare 00000 Zimbabwe Researcher
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information