- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03312647
Adverse Drug Reactions to Anti-TB Drugs in the Treatment of Latent Tuberculosis Infection
Adverse Drug Reactions to Antituberculosis Drugs in the Treatment of Latent Tuberculosis Infection in Korean Health Care Workers
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Sang-Heon Kim, MD, PhD.
- Phone Number: 82-2-2290-8302
- Email: sangheonkim@hanyang.ac.kr
Study Contact Backup
- Name: Dong Won Park, MD, PhD.
- Phone Number: 82-2-2290-8348
- Email: dongwonpark@hanyang.ac.kr
Study Locations
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Seoul, Korea, Republic of
- Recruiting
- Sang-Heon Kim
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Contact:
- Sang-Heon Kim, MD, PhD.
- Phone Number: 82-2-2290-8302
- Email: sangheonkim@hanyang.ac.kr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Latent tuberculosis infection
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The numbers of adverse drug reactions (ADR) during LTBI treatment
Time Frame: one year
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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).
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one year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The numbers of severe ADR during LTBI treatment
Time Frame: one year
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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.
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one year
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Sang-Heon Kim, MD, PhD., Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Chemically-Induced Disorders
- Pathologic Processes
- Disease Attributes
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Actinomycetales Infections
- Mycobacterium Infections
- Latent Infection
- Infections
- Communicable Diseases
- Tuberculosis
- Latent Tuberculosis
- Drug-Related Side Effects and Adverse Reactions
Other Study ID Numbers
- HYUMC_CM_002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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