Adverse Drug Reactions to Anti-TB Drugs in the Treatment of Latent Tuberculosis Infection

Sponsor
Hanyang University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03312647
Collaborator
(none)
1,000
1
10.4
96.3

Study Details

Study Description

Brief Summary

The investigators aim to study the prevalence of adverse reactions of anti-tuberculosis (TB) drugs in latent tuberculosis infection (LTBI), and determine the risk factors of anti-TB drug-related toxicity in LTBI in Korean health care workers(HCWs).

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Further study details as provided by Hanyang University Hospital

    This study is prospective study of newly diagnosed LTBI in HCWs at Hanyang University Hospital, a tertiary referral hospital in South Korea, between 2017 and 2018. This study aimed to identify the prevalence of adverse reactions of treatment regimen for LTBI. The diagnosis of LTBI was made on the basis of interferon-gamma releasing assay. Information on demographic characteristics, comorbidity and treatment outcomes was collated from questionnaires. Treatment regimen for LTBI was chosen by patients' preference among 3 months of INH(isoniazid) plus RFP(rifampin), 4 months of RFP and 9 months of INH. All PTB patients were observed 2 weeks after the initiation of medication, and monthly thereafter, and were asked about any drug side effects at these visits. Serious adverse drug reaction (ADR) was defined as any severe side effect that resulted in discontinuation or change (either temporally or permanently) of anti-TB medication, and/or directly resulted in hospitalization. Drug-induced hepatitis was defined as liver transaminases more than three times higher than the upper limit of normal in the presence of symptoms such as anorexia, nausea, vomiting, or abdominal pain, or transaminases more than five times the upper limit of normal without symptoms.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Adverse Drug Reactions to Antituberculosis Drugs in the Treatment of Latent Tuberculosis Infection in Korean Health Care Workers
    Actual Study Start Date :
    Jun 19, 2017
    Anticipated Primary Completion Date :
    May 1, 2018
    Anticipated Study Completion Date :
    May 1, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    Latent tuberculosis infection

    Identified subjects with latent tuberculosis infection (LTBI) using whole-blood interferon-r release assays. All enrolled subjects were treated with one of the recommended regimens for LTBI treatment: 9 months of isoniazid, 4 months of rifampin and 3 months of isoniazid plus rifampin. Blood, urine sampling, and monitoring frequencies of adverse reactions of anti-TB drugs were performed.

    Outcome Measures

    Primary Outcome Measures

    1. The numbers of adverse drug reactions (ADR) during LTBI treatment [one year]

      All events of adverse drug reactions (ADR) were reported using the clinical signs, symptoms, and liver chemistry at predefined intervals (two weeks after the initiation of anti-TB drugs, and monthly thereafter).

    Secondary Outcome Measures

    1. The numbers of severe ADR during LTBI treatment [one year]

      Among all ADR, serious ADR was defined as any severe side effect that resulted in discontinuation or change (either temporally or permanently) of anti-TB drugs, and/or directly resulted in hospitalization. Drug-induced hepatitis was defined as liver transaminases more than three times higher than the upper limit of normal (γ-glutamyl transpeptidase (γ-GT) >69 U/L; serum glutamic oxaloacetic transminase (SGOT) >54 U/L; serum glutamic pyruvic transminase (SGPT) >60 U/L) in the presence of symptoms such as anorexia, nausea, vomiting, or abdominal pain, or transaminases more than five times the upper limit of normal without symptoms.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 19 years or more

    • Identified latent tuberculosis infection (LTBI) in Korean health care workers, using whole-blood interferon-r release assays

    Exclusion Criteria:
    • Subjects who do not want to participate the present study

    • Subjects who do not receive LTBI treatment due to abnormal liver function test (i.e, liver cirrhosis etc)

    • Subjects with history of previously treated TB

    • Subjects with active tuberculosis infection

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sang-Heon Kim Seoul Korea, Republic of

    Sponsors and Collaborators

    • Hanyang University

    Investigators

    • Study Director: Sang-Heon Kim, MD, PhD., Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dong Won Park, Assistant professor, Hanyang University
    ClinicalTrials.gov Identifier:
    NCT03312647
    Other Study ID Numbers:
    • HYUMC_CM_002
    First Posted:
    Oct 18, 2017
    Last Update Posted:
    Oct 18, 2017
    Last Verified:
    Oct 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dong Won Park, Assistant professor, Hanyang University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 18, 2017