Latent Tuberculosis Infection
Conditions
Keywords
Adverse Drug Reaction, Latent Tuberculosis Infection, Tuberculosis
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.
Interventions
None listed
Sponsors
Hanyang University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Contacts
Primary ContactSang-Heon Kim, MD, PhD.
Backup ContactDong Won Park, MD, PhD.
Outcome results
None listed