Xpert for Tuberculosis: Evaluating a New Diagnostic (XTEND)
| ISRCTN | ISRCTN68905568 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68905568 |
| Secondary identifying numbers | XTEND - Xpert MTB/RIF - TB |
- Submission date
- 25/10/2011
- Registration date
- 04/11/2011
- Last edited
- 30/03/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Tuberculosis (TB) is an infection that mainly affects the lungs, caused by a type of bacterium called Mycobacterium tuberculosis. The Xpert MTB/RIF is an automated diagnostic test that can identify Mycobacterium tuberculosis (MTB) DNA and resistance to the anti-tuberculosis drug rifampicin (RIF). The aim of this study is to find out whether using Xpert MTB/Rif reduces early mortality (death) in patients suspected of having TB, and its cost-effectiveness when used in a routine setting. The overall goal is to better understand how Xpert MTB/RIF should be best used when rolled out nationally in South Africa.
Who can participate?
Patients aged 18 and over suspected of having TB
What does the study involve?
Participating laboratories are randomly allocated to one of two groups. Laboratories in one group test patients’ sputum (phlegm) using a routine TB test (smear) and the other group use the new Xpert MTB/RIF test. Patients who are found to have multi-drug-resistant TB are given the appropriate treatment. After a 6-month follow-up period, the outcomes of the TB patients are compared and the costs and effectiveness of the MTB/RIF test are calculated.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
The Aurum Institute (South Africa)
When is the study starting and how long is it expected to run for?
November 2011 to February 2014
Who is funding the study?
Bill and Melinda Gates Foundation (USA)
Who is the main contact?
Prof. Gavin Churchyard
gchurchyard@auruminstitute.org
Contact information
Scientific
The Aurum Institute
29 Queens Road
The Ridge
Parktown
Johannesburg
2193
South Africa
| Phone | +27 (0)10 590 1300 |
|---|---|
| gchurchyard@auruminstitute.org |
Study information
| Study design | Pragmatic randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Xpert MTB/RIF for diagnosis of tuberculosis: evaluating impact and cost-effectiveness in the routine roll-out in South Africa |
| Study acronym | XTEND |
| Study objectives | The overall goal of the project is to better understand how Xpert Mycobacterium tuberculosis/ resistance to rifampicin (MTB/RIF) should be best used under conditions of national roll-out by determining its effectiveness and cost effectiveness, and modelling these data to project the impact at population level in South Africa. |
| Ethics approval(s) | 1. University of the Witwatersrand, 10/10/2011, ref: M110827 2. The National South African Department of Health (SANCTR, DoH), ref: DOH-27-1011-3849 3. The London School of Hygiene and Tropical Medicine, 07/10/2011, ref: 6041 4. University of Cape Town, 20/10/2010, ref: 363/2011 |
| Health condition(s) or problem(s) studied | Tuberculosis |
| Intervention | The intervention is the implementation of the GeneXpert MTB/RIF Diagnostic Instrument at randomised laboratories. The intervention laboratories will receive Xpert MTB/RIF, with one Xpert MTB/RIF test replacing the two smears at diagnosis. Patients that are sputum Xpert MTB/RIF positive (rifampicin-sensitive) will have a second sputum specimen collected for smear microscopy, to enable reporting of treatment outcomes according to World Health Organisation (WHO) definitions. Patients that are sputum Xpert MTB/RIF rifampicin resistant will be initiated on treatment for Multi-drug-resistant tuberculosis (MDR-TB) pending confirmation of drug susceptibility testing (DST) on positive cultures. The control laboratories will continue to operate the existing standard of care, as per South African National Guideline, with two smears done for all TB suspects, and culture done if smear negative and symptomatic, if high MDR-risk. |
| Intervention type | Other |
| Primary outcome measure | The effectiveness of Xpert MTB/RIF in reducing early mortality in TB suspects |
| Secondary outcome measures | 1. The primary default rate among newly diagnosed TB cases 2. The time from enrolment to start of treatment for drug susceptible TB and appropriate treatment for drug-resistant TB 3. The incremental cost per life saved and disability-adjusted life year (DALY) averted, including reductions in transmission of drug susceptible and drug resistant TB, from a provider and client perspective |
| Overall study start date | 01/11/2011 |
| Completion date | 28/02/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 4400 |
| Key inclusion criteria | 1. The laboratories are placed in four Provinces geographically separate in serving a mix of clinics that have been allocated a GX16 Machine 2. Tuberculosis (TB) suspected participants contribute towards samples evaluated in the laboratories 3. Male and female participants 4. Aged 18 and above |
| Key exclusion criteria | 1. The laboratories part of other TB Xpert MTB/RIF evaluations 2. Laboratories which already have an Xpert MTB/RIF instrument 3. Laboratories which do not comply with standard of care TB diagnostics |
| Date of first enrolment | 01/11/2011 |
| Date of final enrolment | 28/02/2014 |
Locations
Countries of recruitment
- South Africa
Study participating centre
2193
South Africa
Sponsor information
Charity
East Coast Office
PO Box 6176
Ben Franklin Station
Washington DC
20044
United States of America
| Website | http://www.gatesfoundation.org |
|---|---|
"ROR" |
https://ror.org/0456r8d26 |
Funders
Funder type
Charity
Government organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Bill & Melinda Gates Foundation, Gates Foundation, BMGF, B&MGF, GF
- Location
- United States of America
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2015 | Yes | No |
Editorial Notes
30/03/2017: Plain English summary added.
