ISAAC 004

Not Applicable

• Conditions: Tuberculosis

• Registration Number: PACTR201402000765312
• Lead Sponsor: .S. National Institutes of Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-06
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 120

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 <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
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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Initiation of anti-tuberculosis medication by tuberculosis status as determined by microbiologic and clinical assessment committee diagnosis

Secondary Outcome Measures

Name	Time	Method
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