Clinical Analysis of Safety in Latent Tuberculosis Infection Prophylaxis Treatment

NCT04655794 | Unknown FDA Drug

• 1 other identifier: 201800081B0
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The treatment of latent TB with 3HP is an important issue for the prevention of active TB. However, significant proportion of subjects receiving 3HP had adverse reaction. The main purpose of this observation study is to identify subjects who have higher risk to develop adverse reaction. Clinical characteristics and biomarker will be used to predict adverse reaction.

Conditions

Adverse Reaction to Drug; 3HP

Outcome Measures

Primary Outcomes (4)

• sTREM1 between >= grade 2 adverse reaction (SAR group) and< grade 2 adverse reaction (Non-SAR group)

  Change from Baseline sTREM1 at 2 weeks

• sTREM1 between >= grade 2 adverse reaction (SAR group) and< grade 2 adverse reaction (Non-SAR group)

  Change from Baseline sTREM1 at SARs

• sTREM2 between >= grade 2 adverse reaction (SAR group) and< grade 2 adverse reaction (Non-SAR group)

  Change from Baseline sTREM1 at 2 weeks

• sTREM2 between >= grade 2 adverse reaction (SAR group) and< grade 2 adverse reaction (Non-SAR group)

  Change from Baseline sTREM1 at SARs

Study Arms (2)

had >= grade 2 adverse reactions

Drug: 3HP

had <2 frade 2 adverse reactions

Drug: 3HP

Interventions

3HP DRUG

all patients taking 3HP under directly observed preventive therapy (DOPT) program

had <2 frade 2 adverse reactions; had >= grade 2 adverse reactions

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The newly identified LTBI subjects who wanted to receive LTBI preventive therapy with 3HP were eligible for enrolment.

You may qualify if:

• close contact with active TB patients
• patients with autoimmune diseases preceding biological therapy
• health-care workers
• other clinical conditions, which increased the risk of LTBI. LTBI was confirmed by QuantiFERON-TB Gold In-Tube test (QFT-GIT; Qiagen, Valencia, CA, USA) with a cut-off value of 0.35 IU/ml.

You may not qualify if:

• age less than 20 years
• pregnant women
• active TB or suspected active TB in the clinical evaluation
• severe liver disease
• ESRD
• organ transplantation
• close contact with a multidrug-resistant TB patient
• obesity (BMI\>30 Kgw/m2) and other conditions inappropriate for participation in this study as judged by the investigators.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Institutional Review Board Chang Gung Medical Foundation

Taipei, 333, Taiwan

RECRUITING

Related Publications (1)

• Wang TY, Feng JY, Shu CC, Lee SS, Chen CY, Wei YF, Lin CB, Huang WC, Su WJ, Lin SM. Plasma Concentrations of sTREM-1 as Markers for Systemic Adverse Reactions in Subjects Treated With Weekly Rifapentine and Isoniazid for Latent Tuberculosis Infection. Front Microbiol. 2022 Mar 3;13:821066. doi: 10.3389/fmicb.2022.821066. eCollection 2022.

  PMID: 35308376 DERIVED

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Central Study Contacts

Tsai-Yu Wang

CONTACT

+886975368076; wang5531@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 7, 2020
• Study Start: April 19, 2018
• Primary Completion: November 20, 2020
• Study Completion: February 12, 2021
• Last Updated: December 7, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)