Sensitivity and Specificity of Xpert MTB/RIF Ultra

NCT ID: NCT06058065

Last Updated: 2023-10-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-11
• Study Completion Date: 2024-12-25

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.

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.

Conditions

Tuberculosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Hend Mohamed Sayed Mohamed

Lecture of chest diseases

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed yassen, MD

Role: STUDY_CHAIR

Assiut University

Abd-Elmalek Abd-Elmalek, MD

Role: STUDY_CHAIR

Assiut Chest Hospital

Central Contacts

Hend saleh, MD

Role: CONTACT

hend.m.saleh@gmail.com

01098988712

Mohamed Khalaf, MD

Role: CONTACT

dr.mga2011@aun.edu.eg

01026600071

References

Kay AW, Ness T, Verkuijl SE, Viney K, Brands A, Masini T, Gonzalez Fernandez L, Eisenhut M, Detjen AK, Mandalakas AM, Steingart KR, Takwoingi Y. Xpert MTB/RIF Ultra assay for tuberculosis disease and rifampicin resistance in children. Cochrane Database Syst Rev. 2022 Sep 6;9(9):CD013359. doi: 10.1002/14651858.CD013359.pub3.

Reference Type: RESULT

PMID: 36065889 (View on PubMed)

Park M, Kon OM. Use of Xpert MTB/RIF and Xpert Ultra in extrapulmonary tuberculosis. Expert Rev Anti Infect Ther. 2021 Jan;19(1):65-77. doi: 10.1080/14787210.2020.1810565. Epub 2020 Sep 24.

Reference Type: RESULT

PMID: 32806986 (View on PubMed)

Other Identifiers

Ultra Xpert® MTB/RIF

Identifier Type: -

Identifier Source: org_study_id