NCT02170441

Brief 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 rapid diagnosis of extensively drug-resistant TB (XDR-TB).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,128

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2012

Typical duration for all trials

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 12, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 23, 2014

Completed
Last Updated

June 23, 2014

Status Verified

June 1, 2014

Enrollment Period

2.2 years

First QC Date

June 12, 2014

Last Update Submit

June 17, 2014

Conditions

TuberculosisTuberculosis, Multidrug-Resistant

Keywords

TuberculosisMulti-drug resistant tuberculosisExtensively drug-resistant tuberculosisDrug-resistant tuberculosisMycobacterial Growth Indicator Tube Drug Susceptibility TestLine Probe AssayMicroscopic Observation Drug Susceptibility AssayPyrosequencing

Outcome Measures

Primary Outcomes (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).

    Up to 83 weeks

Study Arms (1)

Patients at risk for drug-resistant TB

No intervention

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

P.D. Hinduja National Hospital and Medical Research Centre

Mumbai, India

Location

Phthisiopneumology Institute

Chisinau, Moldova

Location

Department of Biomedical Sciences, Stellenbosch University

Cape Town, South Africa

Location

Related Publications (7)

  • 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.

    PMID: 29499645DERIVED

  • 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.

    PMID: 28475735DERIVED

  • 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.

    PMID: 28404672DERIVED

  • 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.

    PMID: 28381434DERIVED

  • 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.

    PMID: 27576542DERIVED

  • 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.

    PMID: 27090176DERIVED

  • 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.

    PMID: 25377177DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Cultured isolates, processed sputum, extracted DNA (crude lysate from sputum)

MeSH Terms

Conditions

TuberculosisTuberculosis, Multidrug-ResistantExtensively Drug-Resistant Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Antonino Catanzaro, MD

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 12, 2014

First Posted

June 23, 2014

Study Start

April 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

June 23, 2014

Record last verified: 2014-06

Locations

ZA(1)IN(1)MO(1)