MedTrace Logo

Fluoroquinolone Associated Disability

NCT03535558 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 239306

Last updated 2019-01-29

No results posted yet for this study

Summary

The purpose of this study is to: 1) describe drug utilization for Fluoroquinolone(FQ), Azithromycin (AZ) and Sulfamethoxazole/Trimethoprim(ST) in the entire Truven MarketScan Commercial Claims and Encounters database (CCAE) database, and specifically among individuals in the Health and Productivity Management (HPM) during the observation period; 2) describe the rate of disability associated with 2 or more System Organ Class adverse events (SOC AEs) and exposure to FQs for several acute, uncomplicated indications; and 3) compare the rates of disability for 2 or more SOC AEs and exposure to FQs and AZ/ST for the same indications.

Conditions

Interventions

DRUG

Fluoroquinolone (FQ)

Participants exposed to an oral FQ will be observed. The oral FQ included are Levofloxacin, Ciprofloxacin, Moxifloxacin, Ofloxacin, Gemifloxacin. Participants will not receive any intervention as a part of this study.

DRUG

Azithromycin (AZ)

Participants exposed to an oral AZ will be observed. Participants will not receive any intervention as a part of this study.

DRUG

Sulfamethoxazole/Trimethoprim (ST) Fixed Dose Combination

Participants exposed to an oral ST will be observed. Participants will not receive any intervention as a part of this study.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development,LLC Clinical Trial · Janssen Research & Development, LLC

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-17
Primary Completion
2018-12-31
Completion
2018-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03535558 on ClinicalTrials.gov