Fluoroquinolone Associated Disability

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.

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Key information

Conditions

Bronchitis Bronchial Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Lung Diseases Lung Diseases, Obstructive Male Urogenital Diseases Nose Diseases Otorhinolaryngologic Diseases Paranasal Sinus Diseases Respiratory Tract Diseases Respiratory Tract Infections Sinusitis Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Janssen Investigative Site

Titusville, New Jersey, 08560, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluoroquinolone (FQ)

Drug

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)

Drug

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

Drug

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

Primary outcomes

Number of Participants with Disability in Temporal Proximity

Time frame: Up to 120 days

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.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2018
First posted: May 24, 2018
Registry last updated: Jan 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed