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

• Conditions: Latent Tuberculosis Infection

• Registration Number: NCT03312647
• Lead Sponsor: Hanyang University

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).

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 Timeline

• Study First Submitted: 2017-06-18
• Study Start: 2017-06-19
• Status Verified: 2017-10
• Study First Submitted QC: 2017-10-12
• Last Update Submitted: 2017-10-12
• Study First Posted: 2017-10-18
• Last Update Posted: 2017-10-18
• Primary Completion: 2018-05
• Study Completion: 2018-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Sang-Heon Kim; 🇰🇷 Seoul, Korea, Republic of