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NCT Number: NCT04147676

Evaluation of Centralised TB Assay Solutions

Tuberculosis (TB) remains a life-threatening disease partly due to increasing incidence of multidrug and extensively drug-resistant TB. Diagnostic based on culture and conventional drug susceptibility testing using media take several weeks leading to prolonged periods of ineffective therapy and ongoing transmission. Development of rapid molecular diagnostic tests for the identification of Mycobacterium tuberculosis (MTB) and drug resistance has become a high priority.

The Xpert® MTB/RIF Assay does not provide information on INH-resistance and the LPA is only recommended for use in smear-positive samples, complex to perform and requires manual interpretation. Several novel assays have been recently developed/CE-marked offering high sample throughput and higher sensitivity for detection of MTB, RIF- and INH-resistance in centralized laboratories. However, published data on their performance and operational characteristics is extremely limited.

This is a prospective, multicentre, diagnostic accuracy trial in which the performance of centralised TB assay solutions will be assessed at the intended setting of use with culture, phenotypic DST and sequencing as reference standard.

Potential trial participants will be identified at participating TB clinics or hospitals (enrolment sites). Sputum samples will be collected and transported to the associated TB reference laboratories (testing sites).

In order for the results of this trial to be generalizable, adults with symptoms compatible with pulmonary TB undergoing evaluation will be screened for inclusion at geographically diverse participating centres in high burden TB countries. Additionally, to supplement the drug-resistant cases to timely achieve accurate performance estimates, well-characterized frozen sputum samples from the FIND specimen bank will be used.

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Drug-resistant Tuberculosis Gram-Positive Bacterial Infections Infections Mycobacterium Infections Tuberculosis, Multidrug-Resistant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Center for Tuberculosis and Lung Diseases, Tbilisi, Georgia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients are eligible to be included as trial participants only if all of the following inclusion criteria apply:

  • Aged ≥18 years
  • Clinical suspicion of pulmonary TB including cough ≥2 weeks (or any duration if HIV positive ) and ≥1 other symptom typical of pulmonary TB listed below:
  • Fever
  • Malaise
  • Recent weight loss
  • Night sweats
  • Contact with active case
  • Haemoptysis
  • Chest pain
  • Loss of appetite

Exclusion criteria

Participants are excluded from the trial if any of the following exclusion criteria apply:

  • Unwilling or unable to provide informed consent
  • Unwilling to provide four sputum specimens at enrolment i.e. 2x sputa on day 1 and 2x sputa on day 2 (up to 1 week from enrolment)
  • Patients with only extra-pulmonary TB signs & symptoms
  • Receipt of any dose of TB treatment within 6 months prior to enrolment

Treatment and study plan

Primary outcomes

  1. Diagnostic accuracy for MTB detection

    Time frame: four to six months

    clinical sensitivity and specificity by smear-status measured against mycobacterial culture as the reference standard.

  2. Diagnostic accuracy for RIF/INH detection

    Time frame: four to six months

    clinical point estimates of sensitivity and specificity measured against a composite reference standard of phenotypic DST and targeted sequencing.

Secondary outcomes

  1. Operational characteristics:

    Time frame: four to six months

    description of operator experience with the assays through daily observed usage and user appraisal questionnaires.

Sponsors and collaborators

Lead sponsor

Foundation for Innovative New Diagnostics, Switzerland

Other

Registry information

Official study title

Multicentre Trial to Assess the Performance of Centralized Assay Solutions for Detection of MTB and Resistance to Rifampin and Isoniazid

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Nov 1, 2019
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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