Evaluation of GeneXpert Ultra and digital chest radiography for diagnosing tuberculosis

Not Applicable

Completed

• Conditions: Tuberculosis; Infections and Infestations

• Registration Number: ISRCTN77241966
• Lead Sponsor: ondon School of Hygiene and Tropical Medicine

Brief Summary

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35963826/ (added 09/09/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-02
• Study Completion: 2021-08-01
• Last Update Posted: 19 September 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 640

Inclusion Criteria

1. Aged = 18 years
2. Having TB symptoms (cough of any duration, fever, night sweats or weight loss)
3. Able to submit sputum
4. Willing and able to provide informed consent

Exclusion Criteria

1, Presence of clinical danger signs (unable to walk unaided, confused or agitated, breathless when speaking or at rest)
2. Already taking TB treatment, or taken TB treatment within the last 60 days
3. Unable to submit sputum and refuses offer of sputum induction
4. Previously been enrolled in the trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients initiating TB treatment within 28 days of enrolment compared between standard of care Xpert and Xpert Ultra arms

Secondary Outcome Measures

Name	Time	Method
<br> 1. Proportion of patients diagnosed with TB initiating TB treatment within 28 days of enrolment between Standard Of Care and Xpert Ultra arms<br> 2. Time from enrolment to TB treatment initiation between Standard Of Care and Xpert Ultra arms<br> 3. All-cause mortality risk between Standard Of Care and Xpert Ultra arms<br> 4. Proportion of patients diagnosed with bacteriologically-confirmed TB initiating TB treatment within 28 days of enrolment between chest radiography and no chest radiography arms<br>