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TuberculosisGCDDNCT02170441

Global Consortium for Drug-resistant Tuberculosis Diagnostics

An observational study of Tuberculosis and Tuberculosis, Multidrug-Resistant, run by University of California, San Diego at 3 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 5 years and older
How many people
1,128 participants
Where
3 sitesin 3 countries
Study dates
Apr 2012to Jun 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

India1 site

  • P.D. Hinduja National Hospital and Medical Research Centre

    Mumbai

Other trials in India

Moldova1 site

  • Phthisiopneumology Institute

    Chisinau

Other trials in Moldova

South Africa1 site

  • Department of Biomedical Sciences, Stellenbosch University

    Cape Town

Other trials in South Africa

About this study

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).

Read the 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.

Keywords
Tuberculosis, Multi-drug resistant tuberculosis, Extensively drug-resistant tuberculosis, Drug-resistant tuberculosis, Mycobacterial Growth Indicator Tube Drug Susceptibility Test, Line Probe Assay, Microscopic Observation Drug Susceptibility Assay, Pyrosequencing
Medical subject headings
Tuberculosis, Tuberculosis, Multidrug-Resistant, Extensively Drug-Resistant Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02170441
Study groupRoleWhat they receive
Patients at risk for drug-resistant TBNo intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to completion of rapid diagnostic assays

    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).

    Measured: Up to 83 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2014 (estimated)
  2. Study startApr 2012
  3. Primary completionJun 2014
  4. Study completionJun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02170441
Sponsor's protocol ID
09-0099
Other IDs
U01AI082229
Acronym
GCDD
Status last verified
Jun 2014
First submitted
12 Jun 2014
Last updated
23 Jun 2014
Results posted
No
Data monitoring committee
No

Publications

  • Groessl EJ, Ganiats TG, Hillery N, Trollip A, Jackson RL, Catanzaro DG, Rodwell TC, Garfein RS, Rodrigues C, Crudu V, Victor TC, Catanzaro A. Cost analysis of rapid diagnostics for drug-resistant tuberculosis. BMC Infect Dis. 2018 Mar 2;18(1):102. doi: 10.1186/s12879-018-3013-0.

    PubMed 29499645

  • Seifert M, Georghiou SB, Garfein RS, Catanzaro D, Rodwell TC. Impact of Fluoroquinolone Use on Mortality Among a Cohort of Patients With Suspected Drug-Resistant Tuberculosis. Clin Infect Dis. 2017 Sep 1;65(5):772-778. doi: 10.1093/cid/cix422.

    PubMed 28475735

  • Georghiou SB, Seifert M, Catanzaro DG, Garfein RS, Rodwell TC. Increased Tuberculosis Patient Mortality Associated with Mycobacterium tuberculosis Mutations Conferring Resistance to Second-Line Antituberculous Drugs. J Clin Microbiol. 2017 Jun;55(6):1928-1937. doi: 10.1128/JCM.00152-17. Epub 2017 Apr 12.

    PubMed 28404672

  • Catanzaro DG, Trollip AP, Seifert M, Georghiou SB, Garfein RS, Rodwell TC, Catanzaro A, Eisenach KD. Evaluation of the microscopic observation drug susceptibility assay for the detection of first- and second-line drug susceptibility for Mycobacterium tuberculosis. Eur Respir J. 2017 Apr 5;49(4):1602215. doi: 10.1183/13993003.02215-2016. Print 2017 Apr.

    PubMed 28381434

  • Georghiou SB, Seifert M, Lin SY, Catanzaro D, Garfein RS, Jackson RL, Crudu V, Rodrigues C, Victor TC, Catanzaro A, Rodwell TC. Shedding light on the performance of a pyrosequencing assay for drug-resistant tuberculosis diagnosis. BMC Infect Dis. 2016 Aug 31;16(1):458. doi: 10.1186/s12879-016-1781-y.

    PubMed 27576542

  • Georghiou SB, Seifert M, Catanzaro D, Garfein RS, Valafar F, Crudu V, Rodrigues C, Victor TC, Catanzaro A, Rodwell TC. Frequency and Distribution of Tuberculosis Resistance-Associated Mutations between Mumbai, Moldova, and Eastern Cape. Antimicrob Agents Chemother. 2016 Jun 20;60(7):3994-4004. doi: 10.1128/AAC.00222-16. Print 2016 Jul.

    PubMed 27090176

  • Hillery N, Groessl EJ, Trollip A, Catanzaro D, Jackson L, Rodwell TC, Garfein RS, Lin SY, Eisenach K, Ganiats TG, Park D, Valafar F, Rodrigues C, Crudu V, Victor TC, Catanzaro A. The Global Consortium for Drug-resistant Tuberculosis Diagnostics (GCDD): design of a multi-site, head-to-head study of three rapid tests to detect extensively drug-resistant tuberculosis. Trials. 2014 Nov 6;15:434. doi: 10.1186/1745-6215-15-434.

    PubMed 25377177

Questions about this trial

What is this clinical trial studying?

An observational study of Tuberculosis and Tuberculosis, Multidrug-Resistant, run by University of California, San Diego at 3 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in India, Moldova, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to completion of rapid diagnostic assays (time frame: Up to 83 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02170441, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2014.

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