Global Consortium for Drug-resistant Tuberculosis Diagnostics

Tuberculosis Clinical Trial

— GCDD  

Official title:

Global Consortium for Drug-resistant Tuberculosis Diagnostics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02170441
• Other study ID #: 09-0099
• Secondary ID: U01AI082229
• Status: Completed
• Phase: N/A
• First received: June 12, 2014
• Last updated: June 17, 2014
• Start date: April 2012
• Est. completion date: June 2014

Study information

• Verified date: June 2014
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1128
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Tuberculosis
• Tuberculosis, Multidrug-Resistant

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Diego	National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH)

Countries where clinical trial is conducted

India,  Moldova, Republic of,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

External Links

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