Fluoroquinolone Associated Disability

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Urinary Tract Infections; Bronchitis; Sinusitis

Treatments: Drug: Azithromycin (AZ); Drug: Fluoroquinolone (FQ); Drug: Sulfamethoxazole/Trimethoprim (ST) Fixed Dose Combination

Study type: Observational

Funder types: Industry

Identifiers

NCT03535558

CR108484

RRA-20379 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 239,306 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

239,306 participants in 4 patient groups

Cohort 1: FQ With Uncomplicated Sinusitis or Bronchitis

Description:

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.

Treatment:

Drug: Fluoroquinolone (FQ)

Cohort 2: FQ With Uncomplicated Acute Urinary Tract Infection

Description:

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.

Treatment:

Drug: Fluoroquinolone (FQ)

Cohort 3: AZ with Uncomplicated Acute Sinusitis or Bronchitis

Description:

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.

Treatment:

Drug: Azithromycin (AZ)

Cohort 4: ST with Uncomplicated Acute Urinary Tract Infection

Description:

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.

Treatment:

Drug: Sulfamethoxazole/Trimethoprim (ST) Fixed Dose Combination