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

NCT ID: NCT03312647

Last Updated: 2017-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-19

Study Completion Date

2018-05-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Latent Tuberculosis Infection

Keywords

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Adverse Drug Reaction Latent Tuberculosis Infection Tuberculosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hanyang University

OTHER

Sponsor Role lead

Responsible Party

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Dong Won Park

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sang-Heon Kim, MD, PhD.

Role: STUDY_DIRECTOR

Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea

Locations

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Sang-Heon Kim

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Sang-Heon Kim, MD, PhD.

Role: CONTACT

Phone: 82-2-2290-8302

Email: [email protected]

Dong Won Park, MD, PhD.

Role: CONTACT

Phone: 82-2-2290-8348

Email: [email protected]

Facility Contacts

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Sang-Heon Kim, MD, PhD.

Role: primary

Other Identifiers

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HYUMC_CM_002

Identifier Type: -

Identifier Source: org_study_id