Fluoroquinolone Associated Disability

Completed

Conditions studied: Bronchitis, Sinusitis, Urinary Tract Infections

In brief

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.

Key facts

Study ID

NCT03535558

Run by

Janssen Research & Development, LLC

People needed

239306

Starts

2018-05-17

Expected to finish

2018-12-31

Last updated by the study team

2019-01-29

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants in the Truven CCAE database who were eligible for disability insurance and can be linked to the Truven Health and Productivity Management (HPM) database
• Study participants will be included if they have 6 months of history before the first day on FQ or AZ/ST and at least 120 days afterward

You may not qualify if…

• If any protocol specified medical conditions or exposure to the protocol specified medications in the 6 months preceding the first qualifying dose of FQ or AZ/ST
• If participants have any disability claim in the 6 months preceding the qualifying FQ or AZ/ST dose
• If participants have the protocol specified condition-specific diagnoses within the 3 months preceding the qualifying FQ or AZ/ST exposure

Where it is running

• Janssen Investigative Site — Titusville, New Jersey, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.