Xpert MTB/RIF Ultra Trial

NCT07135622 | Completed

• 1 other identifier: req-2019-00422
• Study Type: interventional
• Target: 778
• Locations: 1 country
• Sites: 1

Brief Summary

Tuberculosis (TB) is the leading cause of death caused by infectious agent globally. Estimated 10 million people get ill with TB every year and in 2022 globally there was an increase in Tuberculosis cases, first time since 2010. While in previous years, the decrease in TB numbers was reflecting the impact of disruptions to essential TB services during the COVID-19 pandemic, the increase in numbers in following years have highlighted how severe this disruptions impacted essential TB services. Access to early diagnosis, including drug resistance testing, is essential in the cascade of care. Early diagnosis enables a timely and adequate start of treatment, reducing TB transmission and increasing the likelihood of favorable outcomes of treatment. Most of the tests that are used today to diagnose TB are slow and difficult to use. A few years ago, a new simple and sensitive test for detection of TB was introduced, the Xpert MTB/RIF. A new version of this, Xpert Ultra (Ultra) has been developed. National Center for Tuberculosis and Lung Diseases in collaboration with Swiss Tropical and Public Health Institute is investigating whether new test Xpert / Ultra, when carried out at the Primary Health Care facilities, would help patients in getting a fast and reliable TB diagnosis in the country of Georgia. The study will involve approximately 1600 participants. The study was approved by the local Ethics Committee of the National Center for Tuberculosis and Lung Diseases.

Conditions

Tuberculosis (TB); Pulmonary TB

Keywords

Tuberculosis; Rapid Diagnosis; Xpert/Ultra; RR/MDR-TB; COVID-19

Outcome Measures

Primary Outcomes (2)

• Time from enrolment to TB diagnosis

  Time interval between first approach to PHC and positive TB diagnosis based on laboratory results (i.e. smear, culture, Xpert, Ultra) or clinical judgement

  Time interval between first approach to PHC and TB diagnosis

• Proportion of participants who have bacteriologically confirmed TB and have TB therapy initiated within 7 (30) days of enrolment

  Numerator: Participants with positive smear, culture, Xpert or Ultra result and who are on TB treatment 7 (30) days after enrolment Denominator: All participants of the study arm.

  At 7 (30) days from bacteriological confirmation

Secondary Outcomes (5)

• Number of presumptive TB cases at the PHC facility

  At baseline

• Proportion of patients with early stage TB disease

  From the onset of TB symptoms till the date of diagnostic procedures (X-ray and microscopy) at specialized TB clinics

• Time from onset of symptoms to diagnosis

  Time interval between first TB symptom and TB diagnosis

• Proportion of patients with unfavorable outcomes

  Unfavorable outcomes after enrolment and loss to follow up measured at 6 months

• All-course mortality

  Within 12 months from the end of last patients enrolment

Study Arms (2)

Interventional

EXPERIMENTAL

Presumptive TB cases enrolled at PHC facilities (clusters) randomized in interventional arm

Diagnostic Test: Xpert® MTB/RIF Ultra

Control

ACTIVE COMPARATOR

Presumptive TB cases enrolled at PHC facilities (clusters) randomized in the control arm

Other: Referral to the specialized TB clinics

Interventions

Xpert® MTB/RIF Ultra DIAGNOSTIC_TEST

Xpert® MTB/RIF Ultra test introduced for tuberculosis diagnosis at clinical trial sites randomized to interventional arm

Interventional

Referral to the specialized TB clinics OTHER

No intervention introduced at clinical trial sites randomized to control arm, patients follow standard care: referral to specialized TB clinics

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presumptive pulmonary TB patients, as defined by the NTP treatment guidelines.
• Adults 18 years old and above

You may not qualify if:

• Patients with symptoms which are only attributable to extra-pulmonary TB
• Patients below the age of 18 years

Sponsors & Collaborators

• Nestani Tukvadze: lead
• National Center for Tuberculosis and Lung Disease, Tbilisi, Georgia: collaborator

Study Sites (1)

National Center for Tuberculosis and Lung Diseases

Tbilisi, 0101, Georgia

Location

MeSH Terms

Conditions

Tuberculosis; Tuberculosis, Pulmonary; COVID-19

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD. Principal Investigator

Model Details: Pragmatic, prospective, parallel cluster randomized trial.

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 22, 2025
• Study Start: May 27, 2019
• Primary Completion: February 1, 2023
• Study Completion: February 24, 2023
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GE (1)