Fluoroquinolone Associated Disability

Urinary Tract Infections Clinical Trial

Official title:

Fluoroquinolone Associated Disability

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03535558
• Other study ID #: CR108484
• Secondary ID: RRA-20379
• Status: Completed
• Start date: May 17, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2019
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239306
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Bronchitis
• Sinusitis
• Urinary Tract Infections

Intervention

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

Locations

Country	Name	City	State
United States	Janssen Investigative Site	Titusville	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Disability in Temporal Proximity	Number of participants with disability in temporal proximity to 2 confirmed System Organ Class (SOC) adverse event (AEs) among the 6 of interest (peripheral nervous system, neuropsychiatric, musculoskeletal, sensory, cardiovascular, skin) will be reported. Disability is defined as an incident short-term disability claim in the Health and Productivity Management (HPM) database if it is observed within 120 days of the first Fluoroquinolone(FQ) or Azithromycin/ Sulfamethoxazole/Trimethoprim (AZ/ST) exposure.	Up to 120 days