Tuberculosis(XpertDST)NCT02251327
Feasibility and Accuracy of a Novel Xpert Cartridge
An observational study of Tuberculosis, run by Johns Hopkins University.
Trial summary
Consenting adults will be interviewed for demographic and medical information, and then will be asked to provide two expectorated sputum specimens. In the study laboratory, sputa will be tested using conventional and investigational diagnostic tests for tuberculosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Investigational Xpert DST test
- Type of treatment
- Medical device
- How many people
- 401 participants
- Where
- No sites listed yet
- Study dates
- 4 Jun 2014to Dec 2015
- 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: Adults with clinical signs and/or symptoms of pulmonary TB
Who may be able to join
- Individuals must meet all of the following inclusion criteria in order to be eligible to participate:
- Age ≥ 19 years (age of majority) if enrolled in South Korea; age ≥ 18 years (age of majority) if enrolled in China
- Provision of informed consent
- Clinical signs and/or symptoms suggestive of pulmonary tuberculosis
- Meets one of the following criteria:
- Suspected or confirmed new pulmonary tuberculosis case who has received anti-tuberculosis drugs for less than 3 (three) days (target enrollment for Group A is approximately 50 participants).
- Confirmed pulmonary tuberculosis with documented rifampin resistance, who has received anti-tuberculosis drugs for 31 days or less C. History of prior tuberculosis PLUS ongoing signs and/or symptoms of pulmonary tuberculosis PLUS suspected drug resistance
Who cannot join
- Inability to provide a sputum specimen
About this study
Official title: Feasibility and Accuracy of a Novel Xpert Cartridge for Rapid Molecular Detection of Drug Resistant Mycobacterium Tuberculosis in Sputum
Consenting adults will be interviewed for demographic and medical information, and then will be asked to provide two expectorated sputum specimens. In the study laboratory, sputa will be tested using conventional and investigational diagnostic tests for tuberculosis.
Read the detailed description
- For each of isoniazid, ofloxacin, moxifloxacin, amikacin, and kanamycin: sensitivity and specificity of the investigational Xpert test for detection of drug resistance, using phenotypic drug susceptibility testing as the reference comparator
- For each of isoniazid, ofloxacin, moxifloxacin, amikacin, and kanamycin: sensitivity and specificity of the investigational Xpert test for detection of drug resistance, using mycobacterial DNA sequencing as the reference comparator
- Sensitivity and specificity, for detection of M. tuberculosis in sputum, of the investigational Xpert test and of the conventional Xpert MTB/RIF test, using culture as the reference comparator
- Diagnostic yield (for tuberculosis) of the investigational Xpert test and of the conventional Xpert MTB/RIF test
- For the investigational Xpert test, the proportion of specimens with a result of 'invalid' and the proportion of specimens with a result of 'error'
- Proportion of study participants with M. tuberculosis detected in sputum
- Proportion of participants with drug resistant tuberculosis, by drug resistance pattern and by tuberculosis categorization (new case or not new case)
- Conditions
- Tuberculosis
- Being tested
- Investigational Xpert DST test
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational Xpert DST testDevice
One investigational test performed directly on the same sputum specimen.
| Study group | Role | What they receive |
|---|---|---|
| Case detection group | Suspected or confirmed new pulmonary tuberculosis cases who have received anti-tuberculosis drugs for less than 3 (three) days and provide up to two expectorated sputum specimens. One investigational Xpert DST test and one Xpert MTB/RIF test were performed directly on the same sputum specimen; in addition, one smear microscopy test, one mycobacterial liquid culture, and one solid culture were performed after digestion and decontamination of sputum. Receives: Device: Investigational Xpert DST test | |
| Drug resistance risk group | Confirmed pulmonary tuberculosis cases with documented rifampin resistance, who have received anti-tuberculosis drugs for 31 days or less and/or history of prior tuberculosis PLUS ongoing signs and/or cases with symptoms of pulmonary tuberculosis PLUS suspected drug resistance and provide up to two expectorated sputum specimens. One investigational Xpert DST test and one Xpert MTB/RIF test were performed directly on the same sputum specimen; in addition, one smear microscopy test, one mycobacterial liquid culture, and one solid culture were performed after digestion and decontamination of sputum. Receives: Device: Investigational Xpert DST test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity
sensitivity and specificity of the investigational Xpert DST test for detection of drug resistance, using phenotypic drug susceptibility testing, mycobacterial DNA sequencing, and MTB/RIF test as the reference comparator
Measured: 10 months
Secondary outcomes (3)
Diagnostic yield (for tuberculosis) of the investigational Xpert test and of the conventional Xpert MTB/RIF test
Measured: 10 months
the proportion of specimens with a result of 'invalid' and the proportion of specimens with a result of 'error'
Measured: 10 months
Proportion of study participants with TB and DRTB
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2014 (estimated)
- Study start4 Jun 2014
- Primary completion15 Jun 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02251327
- Sponsor's protocol ID
- NA_0008420
- Other IDs
- NA_0008420
- Acronym
- (XpertDST)
- Status last verified
- Aug 2018
- First submitted
- 23 Sep 2014
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xie YL, Chakravorty S, Armstrong DT, Hall SL, Via LE, Song T, Yuan X, Mo X, Zhu H, Xu P, Gao Q, Lee M, Lee J, Smith LE, Chen RY, Joh JS, Cho Y, Liu X, Ruan X, Liang L, Dharan N, Cho SN, Barry CE 3rd, Ellner JJ, Dorman SE, Alland D. Evaluation of a Rapid Molecular Drug-Susceptibility Test for Tuberculosis. N Engl J Med. 2017 Sep 14;377(11):1043-1054. doi: 10.1056/NEJMoa1614915.
PubMed 28902596
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Accuracy of a Novel Xpert Cartridge for Rapid Molecular Detection of Drug Resistant Mycobacterium Tuberculosis in Sputum
- ClinicalTrials.gov ID
- NCT02251327
- Acronym / sponsor ID
- (XpertDST) / NA_0008420
- Conditions
- Tuberculosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Boston Medical Center
- Study start
- 4 Jun 2014 (actual)
- Primary completion
- 15 Jun 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 29 Sep 2014 (estimated)
- 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 will be interviewed for demographic and medical information, and then will be asked to provide two expectorated sputum specimens. In the study laboratory, sputa will be tested using conventional and investigational diagnostic tests for tuberculosis.
Detailed description
- For each of isoniazid, ofloxacin, moxifloxacin, amikacin, and kanamycin: sensitivity and specificity of the investigational Xpert test for detection of drug resistance, using phenotypic drug susceptibility testing as the reference comparator
- For each of isoniazid, ofloxacin, moxifloxacin, amikacin, and kanamycin: sensitivity and specificity of the investigational Xpert test for detection of drug resistance, using mycobacterial DNA sequencing as the reference comparator
- Sensitivity and specificity, for detection of M. tuberculosis in sputum, of the investigational Xpert test and of the conventional Xpert MTB/RIF test, using culture as the reference comparator
- Diagnostic yield (for tuberculosis) of the investigational Xpert test and of the conventional Xpert MTB/RIF test
- For the investigational Xpert test, the proportion of specimens with a result of 'invalid' and the proportion of specimens with a result of 'error'
- Proportion of study participants with M. tuberculosis detected in sputum
- Proportion of participants with drug resistant tuberculosis, by drug resistance pattern and by tuberculosis categorization (new case or not new case)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case detection group | – | Device: Investigational Xpert DST testSuspected or confirmed new pulmonary tuberculosis cases who have received anti-tuberculosis drugs for less than 3 (three) days and provide up to two expectorated sputum specimens. One investigational Xpert DST test and one Xpert MTB/RIF test were performed directly on the same sputum specimen; in addition, one smear microscopy test, one mycobacterial liquid culture, and one solid culture were performed after digestion and decontamination of sputum. |
| Drug resistance risk group | – | Device: Investigational Xpert DST testConfirmed pulmonary tuberculosis cases with documented rifampin resistance, who have received anti-tuberculosis drugs for 31 days or less and/or history of prior tuberculosis PLUS ongoing signs and/or cases with symptoms of pulmonary tuberculosis PLUS suspected drug resistance and provide up to two expectorated sputum specimens. One investigational Xpert DST test and one Xpert MTB/RIF test were performed directly on the same sputum specimen; in addition, one smear microscopy test, one mycobacterial liquid culture, and one solid culture were performed after digestion and decontamination of sputum. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with clinical signs and/or symptoms of pulmonary TB
Key inclusion criteria (7 listed)
- Individuals must meet all of the following inclusion criteria in order to be eligible to participate:
- Suspected or confirmed new pulmonary tuberculosis case who has received anti-tuberculosis drugs for less than 3 (three) days (target enrollment for Group A is approximately 50 participants).
- Confirmed pulmonary tuberculosis with documented rifampin resistance, who has received anti-tuberculosis drugs for 31 days or less C. History of prior tuberculosis PLUS ongoing signs and/or symptoms of pulmonary tuberculosis PLUS suspected drug resistance
Key exclusion criteria (1 listed)
- Inability to provide a sputum specimen
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 |
|---|---|---|
| Investigational Xpert DST testOne investigational test performed directly on the same sputum specimen. | Device | Case detection group, Drug resistance risk group |
Primary outcome
Sensitivity and specificity
Time frame: 10 months
sensitivity and specificity of the investigational Xpert DST test for detection of drug resistance, using phenotypic drug susceptibility testing, mycobacterial DNA sequencing, and MTB/RIF test as the reference comparator
3 secondary outcomes
Diagnostic yield (for tuberculosis) of the investigational Xpert test and of the conventional Xpert MTB/RIF test
Time frame: 10 months
the proportion of specimens with a result of 'invalid' and the proportion of specimens with a result of 'error'
Time frame: 10 months
Proportion of study participants with TB and DRTB
Time frame: 10 months
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 22 Aug 2018.
- Derived from this study: PubMed 28902596Xie YL, Chakravorty S, Armstrong DT, Hall SL, Via LE, Song T, Yuan X, Mo X, Zhu H, Xu P, Gao Q, Lee M, Lee J, Smith LE, Chen RY, Joh JS, Cho Y, Liu X, Ruan X, Liang L, Dharan N, Cho SN, Barry CE 3rd, Ellner JJ, Dorman SE, Alland D. Evaluation of a Rapid Molecular Drug-Susceptibility Test for Tuberculosis. N Engl J Med. 2017 Sep 14;377(11):1043-1054. doi: 10.1056/NEJMoa1614915.
- Individual participant dataSharing planned: No
Related trials for Tuberculosis
RecruitingPhase 4
Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease
Mycobacterium Avium Complex Pulmonary Disease
RecruitingObservational study
Paradoxical Tuberculosis Reactions in Patients Without HIV Infection
Tuberculosis
Not yet recruitingPhase 2
Re-evaluating the Duration in Children of TB Treatment
Tuberculosis
RecruitingPhase 1/2
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
Tuberculosis
Active, not recruitingPhase 3
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients
Tuberculosis, MDR
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, run by Johns Hopkins University.
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 7 inclusion and 1 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 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Sensitivity and specificity (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02251327, which also lists 1 linked publication.
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 22 Aug 2018.