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.: PACTR201010000255244 Date of Approval: 12/10/2010
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title GeneXpert Demonstration Study MTB/RIF
Official scientific title The impact of rapid molecular diagnosis of tuberculosis on tuberculosis services and patient care ¿ a cluster randomized trial
Brief summary describing the background and objectives of the trial GeneXpert MTB/Rif is a simple automated real-time PCR test for the diagnosis of TB and identification of rifampicin resistance, performed directly on sputum samples. In a recently completed evaluation study GeneXpert showed high sensitivity for both smear negative and positive disease. We aim to evaluate the impact of this diagnostic test on time to treatment and proportion of patients with undiagnosed TB two months after initial presentation to the health care facility.
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 Tuberculosis
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 07/09/2010
Actual trial start date 07/09/2010
Anticipated date of last follow up 09/12/2011
Actual Last follow-up date
Anticipated target sample size (number of participants) 1700
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
REC366/2009 University of Cape Town Research Ethics Committee
REC366/2009 University of Cape Town Research Ethics Committee
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 Independent statistician No concealment - weekly randomization blocks to either intervention or control arms Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised Independent statistician No concealment - weekly randomization blocks to either intervention or control arms Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Xpert arm Two sputum samples: 1. Single smear (concentrated); 2 GeneXpert (direct) 850
Control Group Control arm Two sputum samples: 1. Mycobacterial smear (concentrated); 2. Mycobacterial smear (concentrated) plus MGIT culture 850 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All adult patients presenting to the study clinics for TB investigation, including both: 1. Patients with suspected TB; and 2. Patients with suspected drug-resistant TB, including patients suspected of failing TB treatment Patients currently on TB therapy and undergoing testing for treatment monitoring purposes. 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 20/05/2009 Health Sciences Faculty Research Ethics Committee, University of Cape Town
Ethics Committee Address
Street address City Postal code Country
Room E52-24 Groote Schuur Hospital Old Main Building, Observatory Cape Town 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of patients with untreated TB two months after enrolment (untreated TB defined as patients with TB diagnosed by smear or culture at the 2 month follow up visit, but not before, or patients in whom the diagnosis of TB had been confirmed (smear, culture or Xpert) previously but who had not yet commenced TB treatment at the 2 month follow up visit. 2 months after enrolment
Secondary Outcome Time to appropriate TB treatment (defined as time between enrolment and commencement of appropriate first line or drug-resistant TB treatment) 2 months 6 months
Secondary Outcome Mortality (all cause) 2 months 6 months
Secondary Outcome Time to diagnosis (defined as the time between enrolment and a confirmed diagnosis of TB based on smear, culture or Xpert) 2 months 6 months
Secondary Outcome Number of clinic visits prior to appropriate TB treatment 2 months 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Site B clinic, Khayelitsha Lwandle Road, Site B, Khayelithsa Cape Town South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Foundation for Innovative New Diagnostics 16 Avenue de Bude Geneva 1202 Switzerland
Foundation for Innovative New Diagnostics 16 Avenue de Bude Geneva 1202 Switzerland
The Wellcome Trust 215 Euston Road London NW1 2BE United Kingdom
The Wellcome Trust 215 Euston Road London NW1 2BE United Kingdom
EDCTP 334 Laan van Nieuw Oost Indië, The Hague 2593CE Netherlands
EDCTP 334 Laan van Nieuw Oost Indië, The Hague 2593CE Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Cape Town 5.28 Falmouth, Faculty of Health Sciences, Anzio Road, Observatory Cape Town 7925 South Africa University
Primary Sponsor University of Cape Town 5.28 Falmouth, Faculty of Health Sciences, Anzio Road, Observatory Cape Town 7925 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Foundation for Innovative New Diagnostics 16 Avenue de Bude Geneva 1202 Switzerland
Foundation for Innovative New Diagnostics 16 Avenue de Bude Geneva 1202 Switzerland
Medecins sans Frontieres, Khayelitsha Town One Properties, Site B, Sulani Drive, Khayelitsha Cape Town South Africa
Medecins sans Frontieres, Khayelitsha Town One Properties, Site B, Sulani Drive, Khayelitsha Cape Town South Africa
National Health Laboratory Service 1 Modderfontein Road, Sandringham Johannesburg South Africa
National Health Laboratory Service 1 Modderfontein Road, Sandringham Johannesburg South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mark Nicol Mark.Nicol@uct.ac.za 27 21 406 6083 5.28 Falmouth, Faculty of Health Sciences, Anzio Road, Observatory
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa
Role Name Email Phone Street address
Public Enquiries Mark Nicol Mark.Nicol@uct.ac.za 27 21 406 6083 5.28 Falmouth, Faculty of Health Sciences, Anzio Road, Observatory
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa
Role Name Email Phone Street address
Scientific Enquiries Mark Nicol Mark.Nicol@uct.ac.za 27 21 406 6083 5.28 Falmouth, Faculty of Health Sciences, Anzio Road, Observatory
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information