Condition category
Infections and Infestations
Date applied
25/10/2011
Date assigned
04/11/2011
Last edited
20/07/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 3

Trial website

Contact information

Type

Scientific

Primary contact

Prof Gavin Churchyard

ORCID ID

Contact details

The Aurum Institute
29 Queens Road
The Ridge
Parktown
Johannesburg
2193
South Africa
+27 (0)10 590 1300
gchurchyard@auruminstitute.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

XTEND - Xpert MTB/RIF - TB

Study information

Scientific title

Xpert MTB/RIF for diagnosis of tuberculosis: evaluating impact and cost-effectiveness in the routine roll-out in South Africa

Acronym

XTEND

Study hypothesis

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

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

Study design

Pragmatic randomised trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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 (22), with two smears done for all TB suspects, and culture done if smear negative and symptomatic, if high MDR-risk.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

To measure the effctiveness Xpert MTB/RIF in reducing early mortality in TB suspects

Secondary outcome measures

1. Compare the primary default rate among newly diagnosed TB cases in the intervention arm to the control arm
2. Compare the time from enrolment to start of treatment for drug susceptible TB and appropriate treatment for drug-resistant TB
3. Model 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 trial start date

01/11/2011

Overall trial end date

28/02/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. The laboratories are placed in four Provinces geographically seperate 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

4400

Participant 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

Recruitment start date

01/11/2011

Recruitment end date

28/02/2014

Locations

Countries of recruitment

South Africa

Trial participating centre

The Aurum Institute
Johannesburg
2193
South Africa

Sponsor information

Organisation

Bill and Melinda Gates Foundation (USA)

Sponsor details

East Coast Office
PO Box 6176
Ben Franklin Station
Washington DC
20044
United States of America

Sponsor type

Charity

Website

http://www.gatesfoundation.org

Funders

Funder type

Charity

Funder name

Bill and Melinda Gates Foundation (USA)

Alternative name(s)

Bill & Melinda Gates Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United States of America

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26187490

Publication citations

Additional files

Editorial Notes