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

Hanyang University

Status: Unknown

Conditions: Latent Tuberculosis Infection

Study type: Observational

Funder types: Other

Identifiers

NCT03312647

HYUMC_CM_002

Details and patient eligibility

About

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).

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,000 participants in 1 patient group

Latent tuberculosis infection

Description:

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.