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Xpert MTB/XDR Clinical Evaluation Trial

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ClinicalTrials.gov Identifier: NCT03728725
Recruitment Status : Completed
First Posted : November 2, 2018
Last Update Posted : May 19, 2021
Sponsor:
Collaborators:
Cepheid
PD Hinduja Hospital and Medical Research Centre, Mumbai, India
Phthisiopneumology Institute, Chisinau, Moldova
National Institute of Tuberculosis and Respiratory Disease, New Delhi, India
University of Witwatersrand, South Africa
Information provided by (Responsible Party):
Foundation for Innovative New Diagnostics, Switzerland

Tracking Information
First Submitted Date October 5, 2018
First Posted Date November 2, 2018
Last Update Posted Date May 19, 2021
Actual Study Start Date July 11, 2019
Actual Primary Completion Date August 18, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 16, 2019)
  • Estimate the diagnostic accuracy of the Xpert MTB/XDR assay for INH and ETH resistance detection [ Time Frame: Day 1 ]
    Sensitivity and specificity estimates for INH and ETH resistance detection
  • Estimate the diagnostic accuracy of the Xpert MTB/XDR assay for fluoroquinolone resistance detection [ Time Frame: Day 1 ]
    Sensitivity and specificity estimates for fluoroquinolone resistance detection
  • Estimate the diagnostic accuracy of the Xpert MTB/XDR assay for second-line injectable resistance detection [ Time Frame: Day 1 ]
    Sensitivity and specificity estimates for second-line injectable resistance detection
Original Primary Outcome Measures
 (submitted: November 1, 2018)
  • Estimate the diagnostic accuracy of the Xpert MTB/XDR assay for INH resistance detection [ Time Frame: Day 1 ]
    Sensitivity and specificity estimates for INH resistance detection
  • Estimate the diagnostic accuracy of the Xpert MTB/XDR assay for fluoroquinolone resistance detection [ Time Frame: Day 1 ]
    Sensitivity and specificity estimates for fluoroquinolone resistance detection
  • Estimate the diagnostic accuracy of the Xpert MTB/XDR assay for second-line injectable resistance detection [ Time Frame: Day 1 ]
    Sensitivity and specificity estimates for second-line injectable resistance detection
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Xpert MTB/XDR Clinical Evaluation Trial
Official Title Multicentre Clinical Trial to Assess the Performance of the Xpert MTB/XDR Assay for INH- and Second-line Resistance Detection
Brief Summary FIND and partners intend to address the need for a multi- and extensively drug-resistant tuberculosis (M/XDR-TB) diagnostic solution for patients in settings with a high burden of drug-resistant tuberculosis (DR-TB) though the development, evaluation and introduction of an Xpert MTB/XDR assay
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Sputum will be collected from consenting, enrolled adult participants. Sputum samples may voluntarily be stored for up to 20 years.
Sampling Method Non-Probability Sample
Study Population Individuals who have one or more risk factors for DR-TB presenting to participating centres will be screened by Xpert MTB/RIF or Ultra. Those who test MTB-positive by Xpert MTB/RIF or Ultra at the study sites will be asked to participate. Individuals will be recruited at outpatient clinic settings and inpatient hospital settings. HIV-positive individuals and HIV-negative individuals will be included in this study.
Condition
  • Tuberculosis, Pulmonary
  • Tuberculosis, Multidrug-Resistant
Intervention Device: Cepheid Gene Xpert MTB/XDR
The Xpert MTB/RIF assay (Cepheid, Sunnyvale, CA) is an integrated, automated, cartridge-based system for MDR-TB diagnosis that uses the GeneXpert instrument platform. WHO confirmed evidence to support the widespread use of the Xpert MTB/RIF assay in 2010 and the assay has since been widely used in TB programs, but it is only capable of identifying Mycobacterium tuberculosis (Mtb) and detecting RIF resistance. The Xpert MTB/XDR assay will be evaluated for INH and second-line resistance detection, and to recommend its use in diverse clinical settings. The focus of this protocol is the multicentre clinical evaluation.
Study Groups/Cohorts
  • TB case detection Group
    Patients with pulmonary TB symptoms and at least one DR-TB risk factor will be screened by Xpert MTB/RIF or Ultra. Patients with a clear TB-positive and RIF-resistant or RIF-sensitive result by Xpert MTB/RIF or Ultra and who consent to study procedures will be tested by Xpert MTB/XDR.
    Intervention: Device: Cepheid Gene Xpert MTB/XDR
  • RIF-resistance MTB Group

    An anticipated 316 additional RIF-resistant patients, as detected by Xpert MTB.

    /RIF, will be enrolled in this study to evaluate sensitivity and specificity of the Xpert MTB/XDR test against strains with other potential drug-resistance mutations.

    Intervention: Device: Cepheid Gene Xpert MTB/XDR
Publications * Penn-Nicholson A, Georghiou SB, Ciobanu N, Kazi M, Bhalla M, David A, Conradie F, Ruhwald M, Crudu V, Rodrigues C, Myneedu VP, Scott L, Denkinger CM, Schumacher SG; Xpert XDR Trial Consortium. Detection of isoniazid, fluoroquinolone, ethionamide, amikacin, kanamycin, and capreomycin resistance by the Xpert MTB/XDR assay: a cross-sectional multicentre diagnostic accuracy study. Lancet Infect Dis. 2021 Oct 7. pii: S1473-3099(21)00452-7. doi: 10.1016/S1473-3099(21)00452-7. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 1, 2021)
710
Original Estimated Enrollment
 (submitted: November 1, 2018)
600
Actual Study Completion Date August 18, 2020
Actual Primary Completion Date August 18, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • • Age 18 years or above;

    • Symptoms suggesting pulmonary TB, i.e. persistent cough (generally ≥3 weeks or as per local definition of TB suspect), and at least one of the following:

      • Previously received >1 month of treatment for a prior TB episode or
      • Failing TB treatment with positive sputum smear or culture after ≥3 months of a standard TB treatment or
      • Had close contact with a known drug-resistant TB case or
      • Newly diagnosed with MDR-TB within the last 30 days or
      • Previously diagnosed with MDR-TB and failed TB treatment with positive sputum smear or culture after ≥3 months of a standard MDR-TB treatment regimen

Patients meeting the above criteria will be screened by Xpert MTB/RIF or Xpert MTB/RIF Ultra. TB patients meeting the following criteria will be included in the study:

  • A clear Mtb-positive and RIF-resistant or RIF-sensitive result by Xpert MTB/RIF or Xpert MTB/RIF Ultra
  • Provision of informed consent;
  • Production of an adequate quantity (>3mL) of sputum

Exclusion Criteria:

  • Participants will be excluded from the study if informed consent is not provided.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Moldova, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT03728725
Other Study ID Numbers 7162-02/2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Data sharing statement Individual, de-identified participant data will be shared, including data dictionaries. Other documents that have been made available include the study protocol and statistical analysis plan. Templates of the informed consent forms may be shared upon request. The data will be available immediately following publication with no end date. The data will be shared with anyone who wishes to access the data. The data will be available for any purpose of analyses. For data, please contact the corresponding author.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: Upon publication of final study results
Access Criteria: The data will be shared with anyone who wishes to access the data.
Responsible Party Foundation for Innovative New Diagnostics, Switzerland
Study Sponsor Foundation for Innovative New Diagnostics, Switzerland
Collaborators
  • Cepheid
  • PD Hinduja Hospital and Medical Research Centre, Mumbai, India
  • Phthisiopneumology Institute, Chisinau, Moldova
  • National Institute of Tuberculosis and Respiratory Disease, New Delhi, India
  • University of Witwatersrand, South Africa
Investigators Not Provided
PRS Account Foundation for Innovative New Diagnostics, Switzerland
Verification Date April 2020