Tuberculosis
Conditions
Interventions
Intensified diagnostics
Sponsors
U.S. National Institutes of Health
Kilimanjaro Christian Medical Centre
Duke University Medical Center Division of Infectious Disease
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 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 Hemoptysis CXR consistent with TB OR 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 OR Physician suspicion of pulmonary tuberculosis AND are willing to undergo gastric aspirate
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Initiation of anti-tuberculosis medication by tuberculosis status as determined by microbiologic and clinical assessment committee diagnosis | — |
Secondary
| Measure | Time frame |
|---|---|
| Initiation of anti-tuberculosis medication among smear-negative participants according to randomization arm;Initiation of anti-tuberculosis medication by HIV infection status and randomization arm | — |
Countries
Tanzania
Contacts
Public ContactElizabeth Reddy
Assistant Professor of Medicine, Duke University Division of Infectious Disease
Outcome results
None listed