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Sensitivity and Specificity of Xpert MTB/RIF Ultra

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06058065
Collaborator
(none)
200
Enrollment
12.5
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

To estimate diagnostic accuracy of Xpert Ultra and Xpert MTB/RIF for extrapulmonary tuberculosis and rifampicin resistance in adults suspected to be infected with mycobacterium tuberculosis. In addition, this study will estimate the pattern of rifampicin resistance among TB cases in Assiut population.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Xpert MTB/RIF was introduced recently and added great benefit in management of TB. Xpert MTB/RIF revolutionized the management of Mycobacterium tuberculosis (MTB) infections by providing faster and more accurate MTB diagnosis that detects MTB and rifampicin (RIF) resistance simultaneously. Following World Health Organization (WHO) endorsement in 2010, Xpert MTB/RIF has helped improve TB programs in over 130 countries5.

    Building on this success, faster and more accurate detection of MTB from the first point of encounter in the community is critical. Partnered with GeneXpert® Systems, Xpert MTB/RIF Ultra was delivered with the advantages of improved performance and faster time to result (results within 80 minutes). It has higher sensitivity especially in smear-negative TB cases. The processing of the new assay is easy to use and does not need special expertise5. Xpert MTB/RIF Ultra has increased accuracy of Rifampicin results and improved detection of mixed infections. Recently published recommendations by global experts demonstrate the efficiency of using Xpert MTB/RIF Ultra as a frontline test over smear microscopy or line probe assays followed by culture-based methods for drug susceptibility testing. Thus, a single modification of the diagnostic algorithm to detect smear-positive and smear-negative TB patients improves active case management, is more cost-efficient and could potentially reduce the relative rate of transmission. Using Xpert MTB/RIF Ultra has the potential to reduce the number of missed smear-negative TB patients and may lead to a decrease in total costs of patient care due to the detection of MTB in patient specimens and RIF-resistance in a single test. There is great need for further research to assess the diagnostic value of Xpert MTB/RIF Ultra in patients with pulmonary tuberculosis.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Value of Xpert® MTB/RIF Ultra in Cases With Suspected Tuberculosis
    Anticipated Study Start Date :
    Dec 11, 2023
    Anticipated Primary Completion Date :
    Nov 28, 2024
    Anticipated Study Completion Date :
    Dec 25, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Sensitivity and Specificity of Xpert MTB/RIF Ultra [Baseline]

      By compare with other test

    Secondary Outcome Measures

    1. Prevalence of rifampicin resistance among patients with TB active infection presented to Chest Department in Assiut University Hospital [base line]

      from results

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients presented to Chest Department with suspected pulmonary or extrapulmonary Tuberculosis will be sequentially included
    Exclusion Criteria:
    • Age: less than 18 years. Patients who received anti tuberculous drugs in the past 6 months. Unstable patients or need for ICU admission

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Study Chair: Mohamed yassen, MD, Assiut University
    • Study Chair: Abd-Elmalek Abd-Elmalek, MD, Assiut Chest Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hend Mohamed Sayed Mohamed, Lecture of chest diseases, Assiut University
    ClinicalTrials.gov Identifier:
    NCT06058065
    Other Study ID Numbers:
    • Ultra Xpert® MTB/RIF
    First Posted:
    Sep 28, 2023
    Last Update Posted:
    Oct 4, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Tuberculosis

    Study Results

    No Results Posted as of Oct 4, 2023