Global Consortium for Drug-resistant Tuberculosis Diagnostics (GCDD)

June 17, 2014 updated by: Antonino Catanzaro, University of California, San Diego
The goal of this study is to evaluate time to diagnosis for three assays (line probe, pyrosequencing, and Microscopic Observation Drug Susceptibility Assay [MODS]) to detect resistance to first and second-line anti-tuberculosis (TB) drugs in Mycobacterium tuberculosis (Mtb) strains in 7 days or less, allowing for rapid diagnosis of extensively drug-resistant TB (XDR-TB).

Study Overview

Status

Completed

Conditions

Detailed Description

The goals of this study are to test, fine tune, and compare three tests (line probe, pyrosequencing, MODS assays) to rapidly detect Mycobacterium tuberculosis (Mtb) strains that are resistant to first and second-line anti-tuberculosis (TB) drugs allowing for rapid diagnosis of Extensively Drug-Resistant Tuberculosis (XDR-TB).

Primary Specific Aims

Aim 1: To reduce the average XDR-TB detection time from months to a week.

Aim 2: To determine agreement between rapid tests and standard drug susceptibility testing (DST) results.

Aim 3: To identify the genetic basis of discordant results from Aim 2.

Aim 4: To characterize genotypic, phenotypic and epidemiological features, as well as geographical relationships, of XDR-TB strains compared to other drug-resistant and susceptible strains.

Secondary Aims Aim 1: Cost-effectiveness study. The costs associated with rapid-test implementation will be compared with the performance of the new tests to rapidly and accurately detect drug resistance and XDR-TB.

Aim 2: To determine the predictive value of resistance-associated mutations in determining sputum culture conversion.

The investigators hypothesize that analysis of the genotypic basis of anti-TB drug resistance will allow for the development of improved rapid molecular drug susceptibility tests that will detect resistance to fluoroquinolones and injectable anti-TB drugs and reduce the current XDR-TB diagnosis time of up to three months to less than seven days.

Study Type

Observational

Enrollment (Actual)

1128

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Mumbai, India
        • P.D. Hinduja National Hospital and Medical Research Centre
  • Moldova, Republic of
      • Chisinau, Moldova, Republic of
        • Phthisiopneumology Institute
  • South Africa
      • Cape Town, South Africa
        • Department of Biomedical Sciences, Stellenbosch University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with newly diagnosed or previously treated tuberculosis who are at risk for drug-resistant tuberculosis

Description

Inclusion Criteria:

  • At least 5 years of age
  • Known to be acid fast bacilli (AFB) sputum smear-positive, 1+ or greater (within prior 14 days), positive on GeneXpert, or present clinically with high suspicion of active TB and:
  • Had previously received >1 month of treatment for a prior TB episode or
  • Were failing TB treatment with positive sputum smear or culture after ≥3 months of a standard TB treatment or
  • Had had close contact with a known drug-resistant TB case or
  • Were newly diagnosed with multi-drug resistant TB (MDR-TB) within the last 30 days or
  • Were 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
  • Provided informed consent or had ability and willingness of subject or legal guardian/representative to provide informed consent

Exclusion Criteria:

  • Institutionalized
  • Unable to provide at least 7.5ml sputum (1st and 2nd samples combined)
  • Had results from second line DST performed within the last 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients at risk for drug-resistant TB
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to completion of rapid diagnostic assays
Time Frame: Up to 83 weeks
Time to completion was calculated from date of initial sputum collection to completion of each rapid diagnostic assay. Time frame for analysis of all results was from date of first patient recruited till 21 weeks after last patient recruited (total 83 weeks).
Up to 83 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Antonino Catanzaro, MD, University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

June 12, 2014

First Submitted That Met QC Criteria

June 17, 2014

First Posted (Estimate)

June 23, 2014

Study Record Updates

Last Update Posted (Estimate)

June 23, 2014

Last Update Submitted That Met QC Criteria

June 17, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-0099
  • U01AI082229 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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