TuberculosisNCT04567368
TB-CAPT MTB/XDR Study
An observational study of Tuberculosis and Resistance Bacterial, run by Foundation for Innovative New Diagnostics, Switzerland at 2 sites in South Africa.
Trial summary
The Cepheid Xpert MTB/XDR cartridge, which runs on the same platform as Xpert MTB/RIF Ultra, has been developed to detect additional resistance to isoniazid, fluoroquinolones and second-line injectable anti-tuberculosis drugs and provides results within 2 hours and on primary samples. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis, Resistance Bacterial, Diagnoses Disease
- What is being tested?
- Xpert MTB/XDR
- How many people
- 753 participants
- Where
- 2 sitesSouth Africa
- Study dates
- 14 May 2021to 30 Dec 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Respiratory specimens testing rifampicin-resistant Mtb positive on Xpert MTB/RIF Ultra. The proposed study procedures would not affect the usual care of patients as we will utilise specimens that would ordinarily be discarded. Similarly, the reference standard tests (next generation sequencing) are non-routine tests not currently utilised for patient care in South Africa. These tests will be performed post hoc with patient identifiers removed. For these reasons, we are proposing a waiver of informed consent for this diagnostic accuracy and feasibility study.
Who may be able to join
- Mtb-positive, rifampicin-resistant respiratory specimen identified on Xpert MTB/RIF Ultra
Who cannot join
- Residual SR-sputum mix not retained or not found
- Patient previously included in the study
- Exclusion for diagnostic accuracy and time-to-result endpoints:
- Insufficient residual SR-sputum mix remaining for Xpert MTB/XDR (<2 ml)
- Xpert MTB/XDR unsuccessful
- No second / follow-up specimen received
Show all 10Show fewer
- Second / follow-up specimen culture-negative, contaminated or not available
- Reference standard uninterpretable (phenotyping or WGS)
- Where phenotypic susceptibility testing results are uninterpretable, specimens will still be included in WGS comparison
- Where WGS results are uninterpretable, specimens will still be included in phenotypic susceptibility testing comparison
Trial locations and contacts
2 sites in 1 country.
South Africa2 sites
University of Cape Town
Cape Town
University of the Witwatersrand
Johannesburg
About this study
Official title: Two-site Laboratory-based Diagnostic Accuracy and Feasibility Study of the Xpert MTB/XDR Assay for Detection of Isoniazid, Fluoroquinolone, Ethionamide and Second-line Injectable Anti-tuberculosis Drug Resistance
The Cepheid Xpert MTB/XDR cartridge, which runs on the same platform as Xpert MTB/RIF Ultra, has been developed to detect additional resistance to isoniazid, fluoroquinolones and second-line injectable anti-tuberculosis drugs and provides results within 2 hours and on primary samples. An evaluation of the the Xpert MTB/XDR assay is currently underway in clinical settings in South Africa, India and Moldova. The TB-CAPT MTB/XDR Study will add further diagnostic accuracy and feasibility data to the evidence base for the Xpert MTB/XDR assay.
- Conditions
- Tuberculosis, Resistance Bacterial, Diagnoses Disease
- Being tested
- Xpert MTB/XDR
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xpert MTB/XDRDiagnostic test
Cepheid Xpert MTB/XDR assay for detection of resistance to INH, FQ and SLID
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of Xpert MTB/XDR assay
Sensitivity and specificity of Xpert MTB/XDR assay vs. the composite reference standard for detection of resistance to Isoniazid, Fluoroquinolones, Ethionamide, Second-line injectable anti-tuberculosis drugs
Measured: enrolment
Secondary outcomes (1)
Sensitivity and specificity of Xpert MTB/XDR assay compared to phenotypic anti-tuberculosis drug susceptibility testing and WGS separately
Sensitivity and specificity of Xpert MTB/XDR assay for detection of resistance to Isoniazid, Fluoroquinolones, Ethionamide, Second-line injectable anti-tuberculosis drugs compared to phenotypic anti-tuberculosis drug susceptibility testing and WGS separately
Measured: enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start14 May 2021
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 753 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cape Town, Wits Health Consortium (Pty) Ltd, Ludwig-Maximilians - University of Munich, Ospedale San Raffaele, Swiss Tropical & Public Health Institute, Heidelberg University, African Society for Laboratory Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04567368
- Sponsor's protocol ID
- TB042
- Status last verified
- Sep 2024
- First submitted
- 23 Sep 2020
- Last updated
- 1 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-site Laboratory-based Diagnostic Accuracy and Feasibility Study of the Xpert MTB/XDR Assay for Detection of Isoniazid, Fluoroquinolone, Ethionamide and Second-line Injectable Anti-tuberculosis Drug Resistance
- ClinicalTrials.gov ID
- NCT04567368
- Acronym / sponsor ID
- TB042
- Conditions
- Tuberculosis, Resistance Bacterial, Diagnoses Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 753 participants (actual)
- Lead sponsor
- Foundation for Innovative New Diagnostics, SwitzerlandUniversity, hospital or other
- Collaborators
- University of Cape Town, Wits Health Consortium (Pty) Ltd, Ludwig-Maximilians - University of Munich, Ospedale San Raffaele, Swiss Tropical & Public Health Institute, Heidelberg University, African Society for Laboratory Medicine
- Study start
- 14 May 2021 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 28 Sep 2020 (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.
The Cepheid Xpert MTB/XDR cartridge, which runs on the same platform as Xpert MTB/RIF Ultra, has been developed to detect additional resistance to isoniazid, fluoroquinolones and second-line injectable anti-tuberculosis drugs and provides results within 2 hours and on primary samples. An evaluation of the the Xpert MTB/XDR assay is currently underway in clinical settings in South Africa, India and Moldova. The TB-CAPT MTB/XDR Study will add further diagnostic accuracy and feasibility data to the evidence base for the Xpert MTB/XDR assay.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Respiratory specimens testing rifampicin-resistant Mtb positive on Xpert MTB/RIF Ultra. The proposed study procedures would not affect the usual care of patients as we will utilise specimens that would ordinarily be discarded. Similarly, the reference standard tests (next generation sequencing) are non-routine tests not currently utilised for patient care in South Africa. These tests will be performed post hoc with patient identifiers removed. For these reasons, we are proposing a waiver of informed consent for this diagnostic accuracy and feasibility study.
Key inclusion criteria (1 listed)
- Mtb-positive, rifampicin-resistant respiratory specimen identified on Xpert MTB/RIF Ultra
Key exclusion criteria (10 listed)
- Residual SR-sputum mix not retained or not found
- Patient previously included in the study
- Insufficient residual SR-sputum mix remaining for Xpert MTB/XDR (<2 ml)
- Xpert MTB/XDR unsuccessful
- No second / follow-up specimen received
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/XDRCepheid Xpert MTB/XDR assay for detection of resistance to INH, FQ and SLID | Diagnostic test | – |
Primary outcome
Sensitivity and specificity of Xpert MTB/XDR assay
Time frame: enrolment
Sensitivity and specificity of Xpert MTB/XDR assay vs. the composite reference standard for detection of resistance to Isoniazid, Fluoroquinolones, Ethionamide, Second-line injectable anti-tuberculosis drugs
1 secondary outcome
Sensitivity and specificity of Xpert MTB/XDR assay compared to phenotypic anti-tuberculosis drug susceptibility testing and WGS separately
Time frame: enrolment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis and Resistance Bacterial, run by Foundation for Innovative New Diagnostics, Switzerland at 2 sites in South Africa.
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 1 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in 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?
Results are not available in the source record.
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?
Sensitivity and specificity of Xpert MTB/XDR assay (time frame: enrolment). 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 1 Oct 2024.