Fluoroquinolone Associated Disability

Completed

• Conditions: Urinary Tract Infections; Bronchitis; Sinusitis
• Interventions: Drug: Azithromycin (AZ); Drug: Fluoroquinolone (FQ); Drug: Sulfamethoxazole/Trimethoprim (ST) Fixed Dose Combination

• Registration Number: NCT03535558
• Lead Sponsor: Janssen Research & Development, LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-14
• Study First Submitted QC: 2018-05-14
• Study Start: 2018-05-17
• Study First Posted: 2018-05-24
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-28
• Last Update Posted: 2019-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 239306

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 3: AZ with Uncomplicated Acute Sinusitis or Bronchitis	Azithromycin (AZ)	A comparator cohort which includes participants exposed to oral azithromycin (AZ) with a qualifying indication of uncomplicated acute sinusitis or bronchitis and an occurrence start between 2007-01-01 and 2015-12-31 (inclusive) and are between 18 and 65 years of age (inclusive). All participants must have continuous observation of at least 180 days prior and 120 days after event index date, and all events will be evaluated per participant. The members of the comparator groups will be linked to the Truven HPM data set.
Cohort 2: FQ With Uncomplicated Acute Urinary Tract Infection	Fluoroquinolone (FQ)	A target cohort which includes participants exposed to an oral sulfamethoxazole/trimethoprim (ST) with a qualifying indication of uncomplicated acute urinary tract infection and an occurrence start between 2007-01-01 and 2015-12-31 (inclusive) and are between 18 and 65 years of age (inclusive). All participants must have continuous observation of at least 180 days prior and 120 days after event index date, and all events will be evaluated per participant. The members of the comparator groups will be linked to the Truven HPM data set.
Cohort 4: ST with Uncomplicated Acute Urinary Tract Infection	Sulfamethoxazole/Trimethoprim (ST) Fixed Dose Combination	A comparator cohort which includes participants exposed to oral sulfamethoxazole/trimethoprim (ST) with a qualifying indication of uncomplicated acute urinary tract infection and an occurrence start between 2007-01-01 and 2015-12-31 (inclusive) and are between 18 and 65 years of age (inclusive). All participants must have continuous observation of at least 180 days prior and 120 days after event index date, and all events will be evaluated per participant. The members of the treatment groups will be linked to the Truven Health and Productivity Management (HPM) data set.
Cohort 1: FQ With Uncomplicated Sinusitis or Bronchitis	Fluoroquinolone (FQ)	A target cohort which includes participants exposed to an oral fluoroquinolone (FQ) with an occurrence start between 2007-01-01 and 2015-12-31 (inclusive) and are between 18 and 65 years of age (inclusive). All participants must have continuous observation of at least 180 days prior and 120 days after event index date, and all events will be evaluated per participant. The members of the treatment groups will be linked to the Truven Health and Productivity Management (HPM) data set.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Janssen Investigative Site; 🇺🇸 Titusville, New Jersey, United States