Status:
COMPLETED
Feasibility and Accuracy of a Novel Xpert Cartridge
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Boston Medical Center
Conditions:
Tuberculosis
Eligibility:
All Genders
18+ years
Brief Summary
Consenting adults will be interviewed for demographic and medical information, and then will be asked to provide two expectorated sputum specimens. In the study laboratory, sputa will be tested using ...
Detailed Description
* For each of isoniazid, ofloxacin, moxifloxacin, amikacin, and kanamycin: sensitivity and specificity of the investigational Xpert test for detection of drug resistance, using phenotypic drug suscept...
Eligibility Criteria
Inclusion
- Individuals must meet all of the following inclusion criteria in order to be eligible to participate:
- Age ≥ 19 years (age of majority) if enrolled in South Korea; age ≥ 18 years (age of majority) if enrolled in China
- Provision of informed consent
- Clinical signs and/or symptoms suggestive of pulmonary tuberculosis
- Meets one of the following criteria:
- A. Suspected or confirmed new pulmonary tuberculosis case who has received anti-tuberculosis drugs for less than 3 (three) days (target enrollment for Group A is approximately 50 participants).
- B. Confirmed pulmonary tuberculosis with documented rifampin resistance, who has received anti-tuberculosis drugs for 31 days or less C. History of prior tuberculosis PLUS ongoing signs and/or symptoms of pulmonary tuberculosis PLUS suspected drug resistance
Exclusion
- Inability to provide a sputum specimen
Key Trial Info
Start Date :
June 4 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
401 Patients enrolled
Trial Details
Trial ID
NCT02251327
Start Date
June 4 2014
End Date
December 1 2015
Last Update
August 22 2018
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