Clinical trial NCT03312647: Adverse Drug Reactions to Anti-TB Drugs in the Treatment of Latent Tuberculosis Infection
Official title: Adverse Drug Reactions to Antituberculosis Drugs in the Treatment of Latent Tuberculosis Infection in Korean Health Care Workers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Latent Tuberculosis Infection
Keywords: Adverse Drug Reaction
Latent Tuberculosis Infection
Tuberculosis
Lead sponsor: Hanyang University
Sponsor class: OTHER
First posted: 2017-10-18
Enrollment: 1000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The numbers of adverse drug reactions (ADR) during LTBI treatment
timeFrame: one year
Secondary outcomes:
measure: The numbers of severe ADR during LTBI treatment
timeFrame: one year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Sang-Heon Kim
Study officials:
affiliation: Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea
name: Sang-Heon Kim, MD, PhD.
role: STUDY_DIRECTOR
References: