Multicenter Study of the Accuracy and Feasibility of the Xpert Ultra Test

ational Institute of Allergy and Infectious Diseases (NIAID)0 个研究点开始时间: 2015年12月16日最近更新: 2023年5月29日

适应症

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•Inclusion Criteria for Case Detection Group
•Age 18 years or above;
•Provision of informed consent;
•Willingness to provide up to 4 sputum specimens at enrollment;
•Willingness to have a study follow-up visit 42 to 70 days after enrollment;
•Clinical suspicion of pulmonary TB (including cough ?2 weeks and at least 1 other symptom typical of TB.
•Inclusion Criteria for Drug Resistant TB Group
•Age 18 years or above;
•Provision of informed consent;
•Willingness to provide 3 sputum specimens at enrollment;
•Clinical suspicion of pulmonary TB (including cough ?2 weeks and at least 1 other symptom typical of TB);
•Meets at least one of the following criteria:
•A) microbiologically-confirmed pulmonary TB with documented rifampin resistance who has received anti-tuberculosis therapy for 31 days or less;
•B) known pulmonary TB with suspected treatment failure;
•C) history of drug-resistant TB AND off anti-TB therapy for ? 3 months

•Exclusion Criteria for Case Detection Group
•Receipt of more than two doses (two days) of TB treatment within 6 months prior to enrollment;
•Participants for whom, at the time of enrollment, the follow-up visit is judged to be poorly feasible (e.g. individuals planning to relocate).
•Exclusion Criteria for Drug Resistant TB Group
•No exclusion criteria

发起方

ational Institute of Allergy and Infectious Diseases (NIAID)