Sensitivity and Specificity of Xpert MTB/RIF Ultra
Value of Xpert® MTB/RIF Ultra in Cases With Suspected Tuberculosis
1 other identifier
observational
200
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2023
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2023
CompletedFirst Posted
Study publicly available on registry
September 28, 2023
CompletedStudy Start
First participant enrolled
December 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 25, 2024
CompletedOctober 4, 2023
October 1, 2023
12 months
September 22, 2023
October 1, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Sensitivity and Specificity of Xpert MTB/RIF Ultra
By compare with other test
Baseline
Secondary Outcomes (1)
Prevalence of rifampicin resistance among patients with TB active infection presented to Chest Department in Assiut University Hospital
base line
Eligibility Criteria
Patients referred to Assiut University Hospital with suspected Tuberculosis from July 2023 to June 2024 will be included in the study.
You may qualify if:
- \- Patients presented to Chest Department with suspected pulmonary or extrapulmonary Tuberculosis will be sequentially included
You may not qualify if:
- Age: less than 18 years. Patients who received anti tuberculous drugs in the past 6 months. Unstable patients or need for ICU admission
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
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.
PMID: 36065889RESULTPark 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.
PMID: 32806986RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Mohamed yassen, MD
Assiut University
- STUDY CHAIR
Abd-Elmalek Abd-Elmalek, MD
Assiut Chest Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecture of chest diseases
Study Record Dates
First Submitted
September 22, 2023
First Posted
September 28, 2023
Study Start
December 11, 2023
Primary Completion
November 28, 2024
Study Completion
December 25, 2024
Last Updated
October 4, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share