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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03072576 |
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Date of registration:
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02/03/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Accuracy and Feasibility of Xpert Ultra
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Scientific title:
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A Multicentre Study of the Diagnostic Accuracy and Feasibility of the Xpert Ultra for Detection of TB and Rifampin Resistance in Adults Suspected of Having Pulmonary TB |
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Date of first enrolment:
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March 2016 |
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Target sample size:
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1400 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03072576 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Belarus
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Georgia
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India
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South Africa
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Contacts
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Name:
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Claudia M Denkinger, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Find |
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Key inclusion & exclusion criteria
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Case Detection Group
Inclusion Criteria:
- Age 18 years or above;
- Provision of informed consent;
- Willingness to provide 4 sputum specimens at enrolment;
- Willingness to have a study follow-up visit approximately 42 to 70 days after
enrolment
- Clinical suspicion of pulmonary TB (including cough =2 weeks and at least 1 other
symptom typical of TB)
Exclusion Criteria:
- Receipt of any dose of TB treatment within 6 months prior to enrolment
- Participants for whom, at the time of enrolment, the follow-up visit is judged to be
poorly feasible (e.g. individuals planning to relocate)
Drug-Resistant TB Group
Inclusion Criteria:
- Age 18 years or above;
- Provision of informed consent;
- Willingness to provide 4 sputum specimens at enrolment;
- Non-converting pulmonary TB cases (category I and category II failures) or multi-drug
resistant (MDR) suspect* (based on World Health Organization definition), i.e. at
least one of the following: i) retreatment cases, ii) active TB cases that are
MDR-contacts and iii) patients at high risk for MDR-TB as determined by local program
(e.g. prisoners)
Exclusion Criteria:
• none
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Tuberculosis, Pulmonary
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Intervention(s)
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Device: Xpert MTB/RIF Ultra
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Primary Outcome(s)
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Difference in sensitivity and specificity (ability to correctly identify those with TB and those without TB) between Xpert Ultra and Xpert MTB/ for Mycobacterium tuberculosis (MTB) detection (non-inferiority endpoint)
[Time Frame: Day 1]
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Secondary Outcome(s)
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Proportion of test attempts that do not yield a determinate result for Xpert Ultra and for Xpert MTB/RIF
[Time Frame: Day 1]
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Sensitivity of Xpert Ultra for MTB detection (ability to correctly identify those with TB i.e. true positives), stratified by smear status
[Time Frame: Day 1]
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Difference in sensitivity and specificity (ability to correctly identify those with TB resistant to Rifampin and those with TB susceptible to Rifampin) of Xpert Ultra and Xpert MTB/RIF for detection of RIF resistance
[Time Frame: Day 1]
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Sensitivity and specificity (ability to correctly identify those with TB resistant to Rifampin and those with TB susceptible to Rifampin) of Xpert Ultra for detection of Rifampin (RIF) resistance
[Time Frame: Day 1]
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Secondary ID(s)
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7210-04-2/1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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