Latent Tuberculosis Infection Clinical Trial
Official title:
Adverse Drug Reactions to Antituberculosis Drugs in the Treatment of Latent Tuberculosis Infection in Korean Health Care Workers
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).
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.
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