Xpert for Tuberculosis: Evaluating a New Diagnostic (XTEND)

Not Applicable

Completed

• Conditions: Tuberculosis; Infections and Infestations; Respiratory tuberculosis, bacteriologically and histologically confirmed

• Registration Number: ISRCTN68905568
• Lead Sponsor: Bill and Melinda Gates Foundation (USA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-04
• Last Update Posted: 24 April 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 4400

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The effectiveness of Xpert MTB/RIF in reducing early mortality in TB suspects

Secondary Outcome Measures

Name	Time	Method
1. The primary default rate among newly diagnosed TB cases<br>2. The time from enrolment to start of treatment for drug susceptible TB and appropriate treatment for drug-resistant TB<br>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