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Xpert MTB/RIF Ultra Trial

NCT07135622 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 778

Last updated 2025-08-22

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Xpert® MTB/RIF Ultra

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

OTHER

Referral to the specialized TB clinics

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

Sponsors & Collaborators

  • National Center for Tuberculosis and Lung Disease, Tbilisi, Georgia

    collaborator OTHER

  • Nestani Tukvadze

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-27
Primary Completion
2023-02-01
Completion
2023-02-24

Countries

  • Georgia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07135622 on ClinicalTrials.gov