Clinical trial NCT03728725: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculosis, Pulmonary
Tuberculosis, Multidrug-Resistant
Lead sponsor: Foundation for Innovative New Diagnostics, Switzerland
Sponsor class: OTHER
Collaborators: name: Cepheid
name: PD Hinduja Hospital and Medical Research Centre, Mumbai, India
name: Phthisiopneumology Institute, Chisinau, Moldova
name: National Institute of Tuberculosis and Respiratory Disease, New Delhi, India
name: University of Witwatersrand, South Africa
First posted: 2018-11-02
Enrollment: 710
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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


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.

Primary outcomes:
measure: Estimate the diagnostic accuracy of the Xpert MTB/XDR assay for INH and ETH resistance detection
timeFrame: Day 1
measure: Estimate the diagnostic accuracy of the Xpert MTB/XDR assay for fluoroquinolone resistance detection
timeFrame: Day 1
measure: Estimate the diagnostic accuracy of the Xpert MTB/XDR assay for second-line injectable resistance detection
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Chisinau
country: Moldova, Republic of
facility: Institute of Pthisiopenumology
Study officials:
References:
citation: 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. 2022 Feb;22(2):242-249. doi: 10.1016/S1473-3099(21)00452-7. Epub 2021 Oct 7.