Tuberculosis, PulmonaryNCT03072576
Accuracy and Feasibility of Xpert Ultra
An observational study of Tuberculosis, Pulmonary, run by Foundation for Innovative New Diagnostics, Switzerland at 6 sites in 4 countries.
Trial summary
Consenting adults presenting with signs and symptoms compatible with pulmonary tuberculosis will be interviewed for demographic and medical information, and then will be asked to provide 3-4 expectorated sputum specimens. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis, Pulmonary
- What is being tested?
- Xpert MTB/RIF Ultra
- Type of treatment
- Medical device
- How many people
- 1,400 participants
- Where
- 6 sitesin 4 countries
- Study dates
- Mar 2016to Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals who have symptoms consistent with pulmonary TB presenting to participating centres. Two groups of participants will be recruited, namely a 'Case Detection Group' and a 'Drug-Resistant TB Group'.
Who may be able to join
- 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)
- Age 18 years or above;
Show all 9Show fewer
- 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)
Who cannot join
- 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
- none
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
India3 sites
National Institute for Research in Tuberculosis
Madras
Dept of Microbiology, Hinduja Hospital
Mumbai
New Delhi Tuberculosis Centre
New Delhi
Belarus1 site
Republican Research and Practical Centre for Pulmonology and Tuberculosis
Minsk
Georgia1 site
Clinical Research Unit, National Center for Tuberculosis and Lung Diseases
Tbilisi
South Africa1 site
Department of Molecular Medicine and Haematology, School of Pathology, Faculty of Health Science, University of the Witwatersrand, and The National Priority Program of the National Health Laboratory Service
Johannesburg
About this study
Official title: 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
Consenting adults presenting with signs and symptoms compatible with pulmonary tuberculosis will be interviewed for demographic and medical information, and then will be asked to provide 3-4 expectorated sputum specimens. In the study laboratory, sputa will be tested using conventional and investigational diagnostic tests for tuberculosis and rifampin resistance.
- Conditions
- Tuberculosis, Pulmonary
- Being tested
- Xpert MTB/RIF Ultra
- Keywords
- Diagnosis, Xpert MTB/RIF, Ultra Xpert MTB/RIF
- Medical subject headings
- Tuberculosis, Pulmonary, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xpert MTB/RIF UltraDevice
Also called Cepheid Ultra
Next generation Xpert MTB/RIF assay, this cartridge is intended for the detection of M. tuberculosis in sputum as well as the detection of M. tuberculosis mutations associated with resistance to rifampin
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Day 1
Secondary outcomes (4)
Sensitivity of Xpert Ultra for MTB detection (ability to correctly identify those with TB i.e. true positives), stratified by smear status
Measured: Day 1
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
Measured: Day 1
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
Measured: Day 1
Proportion of test attempts that do not yield a determinate result for Xpert Ultra and for Xpert MTB/RIF
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study startMar 2016
- Primary completionMar 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis, PulmonaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claudia M Denkinger, MD, PhD, Principal investigator, Find
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03072576
- Sponsor's protocol ID
- 7210-04-2/1
- Status last verified
- Feb 2018
- First submitted
- 2 Mar 2017
- Last updated
- 8 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03072576
- Acronym / sponsor ID
- 7210-04-2/1
- Conditions
- Tuberculosis, Pulmonary
- Keywords
- Diagnosis, Xpert MTB/RIF, Ultra Xpert MTB/RIF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,400 participants (actual)
- Lead sponsor
- Foundation for Innovative New Diagnostics, SwitzerlandUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 7 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Consenting adults presenting with signs and symptoms compatible with pulmonary tuberculosis will be interviewed for demographic and medical information, and then will be asked to provide 3-4 expectorated sputum specimens. In the study laboratory, sputa will be tested using conventional and investigational diagnostic tests for tuberculosis and rifampin resistance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who have symptoms consistent with pulmonary TB presenting to participating centres. Two groups of participants will be recruited, namely a 'Case Detection Group' and a 'Drug-Resistant TB Group'.
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xpert MTB/RIF UltraAlso: Cepheid UltraNext generation Xpert MTB/RIF assay, this cartridge is intended for the detection of M. tuberculosis in sputum as well as the detection of M. tuberculosis mutations associated with resistance to rifampin | Device | – |
Primary outcome
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
4 secondary outcomes
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
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
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
Proportion of test attempts that do not yield a determinate result for Xpert Ultra and for Xpert MTB/RIF
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia M Denkinger, MD, PhD principal investigator
Find
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, Pulmonary, run by Foundation for Innovative New Diagnostics, Switzerland at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in India, Belarus, Georgia, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2018.