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Sensitivity and Specificity of Xpert MTB/RIF Ultra

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ClinicalTrials.gov Identifier: NCT06058065
Recruitment Status : Not yet recruiting
First Posted : September 28, 2023
Last Update Posted : October 4, 2023
Sponsor:
Information provided by (Responsible Party):
Hend Mohamed Sayed Mohamed, Assiut University

Study Description
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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
Tuberculosis

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Sensitivity and Specificity of Xpert MTB/RIF Ultra [ Time Frame: 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 [ Time Frame: base line ]
    from results


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients referred to Assiut University Hospital with suspected Tuberculosis from July 2023 to June 2024 will be included in the study.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06058065


Contacts
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Contact: Hend saleh, MD 01098988712 hend.m.saleh@gmail.com
Contact: Mohamed Khalaf, MD 01026600071 dr.mga2011@aun.edu.eg

Sponsors and Collaborators
Assiut University
Investigators
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Study Chair: Mohamed yassen, MD Assiut University
Study Chair: Abd-Elmalek Abd-Elmalek, MD Assiut Chest Hospital
More Information
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Publications of Results:

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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: September 28, 2023    Key Record Dates
Last Update Posted: October 4, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
 Bacterial Infections
Bacterial Infections and Mycoses
Infections