Effect of an Intensified Patient-specific TB Diagnostic Strategy on Treatment Decisions by Physicians Caring for Adults and Children with Suspected Pulmonary Tuberculosis in the Kilimanjaro Region of Tanzania

.S. National Institutes of Health0 个研究点目标入组 120 人开始时间: 2014年2月6日最近更新: 2023年5月29日

适应症

试验速览

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•For all participants:
•Are able and willing to provide written informed consent if aged 18 or older, assent if aged 12-17, or legal guardian able to consent if <12 years of age.
•Reside within the Kilimanjaro Region of Tanzania.
•Are willing to be tested for HIV-1.
•For adults and children > or equal to 6 years of age-
•Are suspected to have pulmonary tuberculosis, defined as:
•Cough for 2 or more weeks and one or more of the following, without another substantiated diagnosis (e.g., cytology showing lung cancer)
•Reported or documented recurrent fever, ¿38.0 C, over previous 2 weeks
•Weight loss or failure to thrive not explained through poor nutrition
•Night sweats recurrent over previous 2 weeks
•CXR consistent with TB
•Physician suspicion of pulmonary tuberculosis
•For children <6 years of age:
•Are suspected to have pulmonary tuberculosis, defined as:
•Any 2 of the following symptoms, without another substantiated diagnosis
•Cough or shortness of breath for 2 or more weeks
•Reported or documented recurrent fever, ¿38.0 C, over previous 2 weeks
•Weight loss or failure to thrive not explained through poor nutrition
•Night sweats recurrent over previous 2 weeks
•Exposure to adult with pulmonary TB in last 2 years
•CXR consistent with TB
•Physician suspicion of pulmonary tuberculosis
•AND are willing to undergo gastric aspirate

•Have received more than 3 days of anti-TB therapy in the 2 weeks preceding enrollment, or more than 2 weeks of anti-TB treatment in the 3 months preceding enrollment. This includes prophylactic INH in an exposed child or adult.
•Have been previously included in the ISAAC 004 protocol
•Participating in another research study that in the opinion of the PI would influence the likelihood of TB treatment completion or other ISAAC 004 study aims or exceed the maximum blood volume for laboratory testing.
•Have an obvious psychological or psychiatric disorder that would preclude provision of informed consent or otherwise contraindicate study participation, or for children < 18 years, the only available legal guardian has such a condition.
•Have been conclusively or presumptively diagnosed with another condition explaining the symptoms and the possibility of TB is not under active consideration by the clinical care providers
•Subjects who undergo bronchoscopy to obtain BAL will be ineligible for the study

发起方

.S. National Institutes of Health