TBNEATXpertRCT

Not Applicable

Recruiting

• Conditions: Tuberculosis

• Registration Number: PACTR201107000309419
• Lead Sponsor: Greg Hussey

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-07
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

1. Able and willing to give informed consent
2.

Ambulant patient presenting to TB clinic

IF HIV negative requires 2 or more of the following:
* Cough ¿ 2 weeks
* loss of weight
* persistent fever ¿ 2 weeks and/or
* a single recorded temp > 38°C
* night sweats
* generalized fatigue
* hemoptysis or
* chest pain

OR if HIV positive - any one of the following:
* current cough
* night sweats
* fever
* loss of weight
3. Patient 18 years or above

Exclusion Criteria

Exclusion Criteria:

1. Inability to provide informed consent (e.g. mentally impaired)
2. Unable to produce 2 sputa of ¿ 1ml
3. TB treatment within the last 60 days
4. Unable to potentially return for study follow-up at 2 and 6 months (i.e. leaving community)
5. Patient not meeting inclusion criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time-to-initiation of treatment;Mean difference in TB score at 2 and 6 months follow-up

Secondary Outcome Measures

Name	Time	Method
Time-to-diagnosis;Drop-out and lost-to-follow up rates;Feasibility of clinic-based performance of Xpert MTB/RIF assay performed by nursing staff without formal research training;Individual patient-level cost analysis, cost-effectiveness evaluation and quality of health indices evaluation