Bronchitis, Sinusitis, Urinary Tract Infections
Conditions
Brief 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.
Interventions
DRUGFluoroquinolone (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.
Participants exposed to an oral AZ will be observed. Participants will not receive any intervention as a part of this study.
DRUGSulfamethoxazole/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
Janssen Research & Development, LLC
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Disability in Temporal Proximity | 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. |
Countries
United States
Outcome results
None listed