Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03312647
Recruitment Status : Recruiting
First Posted : October 18, 2017
Last Update Posted : October 18, 2017
Sponsor:
Information provided by (Responsible Party):
Dong Won Park, Hanyang University

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).

Condition or disease
Latent Tuberculosis Infection

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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Adverse Drug Reactions to Antituberculosis Drugs in the Treatment of Latent Tuberculosis Infection in Korean Health Care Workers
Actual Study Start Date : June 19, 2017
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. The numbers of adverse drug reactions (ADR) during LTBI treatment [ Time Frame: 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 Outcome Measures :
  1. The numbers of severe ADR during LTBI treatment [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
whole blood sampling


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03312647


Contacts
Layout table for location contacts
Contact: Sang-Heon Kim, MD, PhD. 82-2-2290-8302 sangheonkim@hanyang.ac.kr
Contact: Dong Won Park, MD, PhD. 82-2-2290-8348 dongwonpark@hanyang.ac.kr

Locations
Layout table for location information
Korea, Republic of
Sang-Heon Kim Recruiting
Seoul, Korea, Republic of
Contact: Sang-Heon Kim, MD, PhD.    82-2-2290-8302    sangheonkim@hanyang.ac.kr   
Sponsors and Collaborators
Hanyang University
Investigators
Layout table for investigator information
Study Director: Sang-Heon Kim, MD, PhD. Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea

Layout table for additonal information
Responsible Party: Dong Won Park, Assistant professor, Hanyang University
ClinicalTrials.gov Identifier: NCT03312647     History of Changes
Other Study ID Numbers: HYUMC_CM_002
First Posted: October 18, 2017    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dong Won Park, Hanyang University:
Adverse Drug Reaction
Latent Tuberculosis Infection
Tuberculosis

Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Tuberculosis
Latent Tuberculosis
Drug-Related Side Effects and Adverse Reactions
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Chemically-Induced Disorders