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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02170441 |
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Date of registration:
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12/06/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Global Consortium for Drug-resistant Tuberculosis Diagnostics
GCDD |
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Scientific title:
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Global Consortium for Drug-resistant Tuberculosis Diagnostics |
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Date of first enrolment:
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April 2012 |
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Target sample size:
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1128 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02170441 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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India
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Moldova, Republic of
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South Africa
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Contacts
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Name:
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Antonino Catanzaro, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of California, San Diego |
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Key inclusion & exclusion criteria
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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
Age minimum:
5 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Tuberculosis, Multidrug-Resistant
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Tuberculosis
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Primary Outcome(s)
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Time to completion of rapid diagnostic assays
[Time Frame: Up to 83 weeks]
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Secondary ID(s)
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U01AI082229
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09-0099
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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