Infant TB Infection Prevention Study

Tuberculosis Clinical Trial

— iTIPS  

Official title:

Preventing Mycobacterium Tuberculosis Infection in HIV-Exposed Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02613169
• Other study ID #: STUDY00000341
• Status: Completed
• Phase: Phase 2
• Start date: August 2016
• Est. completion date: December 2020

Study information

• Verified date: March 2023
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2020
• Est. primary completion date: October 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Weeks to 10 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Infections
• Tuberculosis

Intervention

Drug:
• Isoniazid
HIV-exposed uninfected infants will be randomized to receive either INH or no INH daily for 12 months for the prevention of Mycobacterium tuberculosis (MTB) infection.

Locations

Country	Name	City	State
Kenya	Kisumu County Hospital	Kisumu

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Thrasher Research Fund

Country where clinical trial is conducted

Kenya, 

References & Publications (3)

LaCourse SM, Escudero JN, Mecha J, Warr AJ, Richardson BA, Carimo N, Cranmer LM, Maleche-Obimbo E, Matemo D, Kinuthia J, Hawn TR, John-Stewart G. Cumulative Mycobacterium tuberculosis Infection Incidence (Measured Primarily by Tuberculin Skin Test) Among — View Citation

Madhi SA, Nachman S, Violari A, Kim S, Cotton MF, Bobat R, Jean-Philippe P, McSherry G, Mitchell C; P1041 Study Team. Primary isoniazid prophylaxis against tuberculosis in HIV-exposed children. N Engl J Med. 2011 Jul 7;365(1):21-31. doi: 10.1056/NEJMoa1011214. — View Citation

Zar HJ, Cotton MF, Strauss S, Karpakis J, Hussey G, Schaaf HS, Rabie H, Lombard CJ. Effect of isoniazid prophylaxis on mortality and incidence of tuberculosis in children with HIV: randomised controlled trial. BMJ. 2007 Jan 20;334(7585):136. doi: 10.1136/bmj.39000.486400.55. Epub 2006 Nov 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mycobacterium Tuberculosis (MTB) Infection	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	at 12 months post randomization
Primary	Mycobacterium Tuberculosis (MTB) Infection Cumulative Incidence	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	at 12 months post randomization
Secondary	Severe Adverse Events (SAE)	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	Over 12 months after randomization
Secondary	Combined Outcome of MTB Infection, TB Disease, and Death	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	Over 12 months after randomization
Secondary	Combined Outcome of MTB Infection Including IGRA, TST, and Additional Interferon-gamma-independent Immune Markers in QFT-Plus Supernatants	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).	Over 12 months after randomization