Phase 2
N=300
Infant TB Infection Prevention Study
Tuberculosis
Bottom Line
View on ClinicalTrials.gov: NCT02613169 ↗Enrolled (actual)
300
Serious AEs
12.3%
Results posted
Jun 2021
Primary outcome: Primary: Mycobacterium Tuberculosis (MTB) Infection — 10; 18 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Isoniazid (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mycobacterium Tuberculosis (MTB) Infection |
10; 18 | — |
| PRIMARY Mycobacterium Tuberculosis (MTB) Infection Cumulative Incidence |
7.0; 13.4 | — |
| SECONDARY Severe Adverse Events (SAE) |
21; 16 | — |
| SECONDARY Combined Outcome of MTB Infection, TB Disease, and Death |
11; 19 | — |
| SECONDARY Combined Outcome of MTB Infection Including IGRA, TST, and Additional Interferon-gamma-independent Immune Markers in QFT-Plus Supernatants |
— | — |
Summary
Randomized controlled trial (RCT) of isoniazid (INH) vs. no INH to prevent Mycobacterium tuberculosis infection in HIV-exposed uninfected (HEU) infants.
Eligibility Criteria
Inclusion Criteria
- HIV exposed infants
- Aged 6 weeks within (+ 4 weeks)
- Born to HIV-infected mothers
- Not premature and over 2.5 kg
Exclusion Criteria
- Infants with known exposure to active TB in household
- Premature and < 2.5 kg
Data sourced from ClinicalTrials.gov (NCT02613169). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.