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

NCT03312647 | Unknown DMC

• 1 other identifier: HYUMC_CM_002
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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).

Conditions

Latent Tuberculosis Infection

Keywords

Adverse Drug Reaction; Latent Tuberculosis Infection; Tuberculosis

Outcome Measures

Primary Outcomes (1)

• The numbers of adverse drug reactions (ADR) during LTBI treatment

  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).

  one year

Secondary Outcomes (1)

• The numbers of severe ADR during LTBI treatment

  one year

Study Arms (1)

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.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects diagnosed with latent tuberculosis infection (LTBI) using whole-blood interferon-r release assays in Korean health care workers.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanyang University: lead

Study Sites (1)

Sang-Heon Kim

Seoul, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood sampling

MeSH Terms

Conditions

Latent Tuberculosis; Drug-Related Side Effects and Adverse Reactions; Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection; Chemically-Induced Disorders

Study Officials

• Sang-Heon Kim, MD, PhD.

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

  STUDY DIRECTOR

Central Study Contacts

Sang-Heon Kim, MD, PhD.

CONTACT

82-2-2290-8302; sangheonkim@hanyang.ac.kr

Dong Won Park, MD, PhD.

CONTACT

82-2-2290-8348; dongwonpark@hanyang.ac.kr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: June 18, 2017
• First Posted: October 18, 2017
• Study Start: June 19, 2017
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: October 18, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)