Fluoroquinolone Associated Disability

NCT03535558 | Completed FDA Drug

• 2 other identifiers: CR108484RRA-20379
• Study Type: observational
• Target: 239,306
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchitis; Sinusitis; Urinary Tract Infections

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Cohort 1: FQ With Uncomplicated Sinusitis or Bronchitis

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.

Drug: Fluoroquinolone (FQ)

Cohort 2: FQ With Uncomplicated Acute Urinary Tract Infection

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.

Drug: Fluoroquinolone (FQ)

Cohort 3: AZ with Uncomplicated Acute Sinusitis or Bronchitis

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.

Drug: Azithromycin (AZ)

Cohort 4: ST with Uncomplicated Acute Urinary Tract Infection

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.

Drug: Sulfamethoxazole/Trimethoprim (ST) Fixed Dose Combination

Interventions

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.

Cohort 1: FQ With Uncomplicated Sinusitis or Bronchitis; Cohort 2: FQ With Uncomplicated Acute Urinary Tract Infection

Azithromycin (AZ) DRUG

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

Cohort 3: AZ with Uncomplicated Acute Sinusitis or Bronchitis

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.

Cohort 4: ST with Uncomplicated Acute Urinary Tract Infection

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will include participants in the Truven Commercial Claims and Encounters (CCAE) database who were eligible for disability insurance and can be linked to the Truven HPM database. The study population will include individuals who had uncomplicated acute bacterial sinusitis, or bronchitis and were prescribed an oral fluoroquinolone (FQ) or oral azithromycin(AZ) and sulfamethoxazole/trimethoprim (ST) for urinary tract infection.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Janssen Investigative Site

Titusville, New Jersey, 08560, United States

Location

MeSH Terms

Conditions

Bronchitis; Sinusitis; Urinary Tract Infections

Interventions

Fluoroquinolones; Azithromycin; Sulfamethoxazole; Trimethoprim

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Benzenesulfonamides; Sulfonamides; Amides; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Janssen Research & Development,LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2018
• First Posted: May 24, 2018
• Study Start: May 17, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: January 29, 2019

Record last verified: 2019-01

Locations

US (1)