Clinical Analysis of Safety in Latent Tuberculosis Infection Prophylaxis Treatment

Sponsor
Chang Gung Memorial Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04655794
Collaborator
(none)
500
1
33.8
14.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Clinical Analysis of Safety in Latent Tuberculosis Infection Prophylaxis Treatment
Actual Study Start Date :
Apr 19, 2018
Actual Primary Completion Date :
Nov 20, 2020
Anticipated Study Completion Date :
Feb 12, 2021

Arms and Interventions

Arm Intervention/Treatment
had >= grade 2 adverse reactions

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

had <2 frade 2 adverse reactions

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

Outcome Measures

Primary Outcome Measures

  1. sTREM1 between >= grade 2 adverse reaction (SAR group) and< grade 2 adverse reaction (Non-SAR group) [Change from Baseline sTREM1 at 2 weeks]

  2. sTREM1 between >= grade 2 adverse reaction (SAR group) and< grade 2 adverse reaction (Non-SAR group) [Change from Baseline sTREM1 at SARs]

  3. sTREM2 between >= grade 2 adverse reaction (SAR group) and< grade 2 adverse reaction (Non-SAR group) [Change from Baseline sTREM1 at 2 weeks]

  4. sTREM2 between >= grade 2 adverse reaction (SAR group) and< grade 2 adverse reaction (Non-SAR group) [Change from Baseline sTREM1 at SARs]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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.

Exclusion Criteria:
  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institutional Review Board Chang Gung Medical Foundation Taipei Taiwan 333

Sponsors and Collaborators

  • Chang Gung Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT04655794
Other Study ID Numbers:
  • 201800081B0
First Posted:
Dec 7, 2020
Last Update Posted:
Dec 7, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 7, 2020