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Xpert MTB/XDR Clinical Evaluation Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03728725
Recruitment Status : Recruiting
First Posted : November 2, 2018
Last Update Posted : August 1, 2019
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

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

Condition or disease Intervention/treatment
Tuberculosis, Pulmonary Tuberculosis, Multidrug-Resistant Device: Cepheid Gene Xpert MTB/XDR

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Multicentre Clinical Trial to Assess the Performance of the Xpert MTB/XDR Assay for INH- and Second-line Resistance Detection
Actual Study Start Date : July 11, 2019
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Group/Cohort Intervention/treatment
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.
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.

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.

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.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Biospecimen Retention:   Samples Without DNA
Sputum will be collected from consenting, enrolled adult participants. Sputum samples may voluntarily be stored for up to 20 years.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03728725


Contacts
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Contact: Adam Penn-Nicholsson, PhD +4122710 05 90 adam.penn-nicholson@finddx.org

Locations
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Moldova, Republic of
Institute of Pthisiopenumology Recruiting
Chisinau, Moldova, Republic of
Contact: Valeriu Crudu, MD         
Sponsors and Collaborators
Foundation for Innovative New Diagnostics, Switzerland
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

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Responsible Party: Foundation for Innovative New Diagnostics, Switzerland
ClinicalTrials.gov Identifier: NCT03728725    
Other Study ID Numbers: 7162-02/2
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tuberculosis
Tuberculosis, Pulmonary
Tuberculosis, Multidrug-Resistant
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections