Infant TB Infection Prevention Study

Phase 2

Completed

• Conditions: Tuberculosis
• Interventions: Drug: Isoniazid

• Registration Number: NCT02613169
• Lead Sponsor: University of Washington

Brief Summary

Randomized controlled trial (RCT) of isoniazid (INH) vs. no INH to prevent Mycobacterium tuberculosis infection in HIV-exposed uninfected (HEU) infants.

Detailed Description

The purpose of this trial is to determine whether isoniazid (INH) reduces the risk of Mycobacterium tuberculosis (MTB) infection in HIV-exposed but uninfected (HEU) children, as well as to determine epidemiologic and immunologic correlates of MTB infection in HEU.

Study Timeline

• Study First Submitted: 2015-09-16
• Study First Submitted QC: 2015-11-19
• Study First Posted: 2015-11-24
• Study Start: 2016-08
• Primary Completion: 2019-10
• Results First Submitted: 2020-11-12
• Study Completion: 2020-12
• Results First Submitted QC: 2021-05-15
• Results First Posted: 2021-06-10
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-31
• Last Update Posted: 2023-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• HIV exposed infants
• Aged 6 weeks within (+ 4 weeks)
• Born to HIV-infected mothers
• Not premature and over 2.5 kg

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Exclusion Criteria

• Infants with known exposure to active TB in household
• Premature and < 2.5 kg

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Isoniazid	Isoniazid	Isoniazid (INH) \~10 mg/kg (7-15 mg/kg), will be administered once daily to infants in INH arm for 12 months.

Primary Outcome Measures

Name	Time	Method
Mycobacterium Tuberculosis (MTB) Infection	at 12 months post randomization	Among HEU infants enrolled at approximately 6 weeks of age, compare the risk of acquiring MTB infection during 1 year of follow-up in infants randomized to receive INH vs. no INH using an interferon-gamma release (IGRA) QuantiFERON-TB Gold Plus (QFT-Plus) assay or tuberculin skin test as part of a composite endpoint to determine MTB infection status
Mycobacterium Tuberculosis (MTB) Infection Cumulative Incidence	at 12 months post randomization	Among HEU infants enrolled at approximately 6 weeks of age, compare the risk of acquiring MTB infection during 1 year of follow-up in infants randomized to receive INH vs. no INH using an interferon-gamma release (IGRA) QuantiFERON-TB Gold Plus (QFT-Plus) assay or tuberculin skin test as part of a composite endpoint to determine MTB infection status

Secondary Outcome Measures

Name	Time	Method
Severe Adverse Events (SAE)	Over 12 months after randomization	Number of infants with grade 3 or higher treatment-related adverse events as assessed by DAIDS Table for the Grading Severity of Pediatric Adverse Experiences
Combined Outcome of MTB Infection, TB Disease, and Death	Over 12 months after randomization	Number of infants with a combined endpoint of MTB infection, TB disease, and death; * MTB infection as measured by IGRA or tuberculin skin test at 12 months post-enrollment; * TB disease including microbiologically confirmed (culture or Xpert positive), or probable TB (clinical diagnosis).; * Death of infant
Combined Outcome of MTB Infection Including IGRA, TST, and Additional Interferon-gamma-independent Immune Markers in QFT-Plus Supernatants	Over 12 months after randomization	Number of infants with MTB infection as measured by; * IGRA, or; * Tuberculin skin test (\>10 mm) at 12 months post-enrollment, or; * Interferon-gamma-independent immune markers in QFT-Plus supernatants; Combined outcome will be defined as positive if IGRA OR TST OR interferon-gamma-independent marker is positive and combined outcome will be defined as negative if none of these is positive (if children do not have all three markers the definition will hold for available markers).

Trial Locations

Locations (1)

Kisumu County Hospital; 🇰🇪 Kisumu, Kenya