BronchitisNCT03535558
Fluoroquinolone Associated Disability
An observational study of Bronchitis and Sinusitis, run by Janssen Research & Development, LLC at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bronchitis, Sinusitis, Urinary Tract Infections
- What is being tested?
- Fluoroquinolone (FQ), Azithromycin (AZ) and Sulfamethoxazole/Trimethoprim (ST) Fixed Dose Combination
- Type of treatment
- Pill or oral medicine
- How many people
- 239,306 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2018to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Janssen Investigative Site
Titusville, New Jersey, 08560
About this study
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
- Being tested
- Fluoroquinolone (FQ), Azithromycin (AZ), Sulfamethoxazole/Trimethoprim (ST) Fixed Dose Combination
- Medical subject headings
- Bronchitis, Sinusitis, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 CombinationDrug
Participants exposed to an oral ST will be observed. Participants will not receive any intervention as a part of this study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Sulfamethoxazole/Trimethoprim (ST) Fixed Dose Combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start17 May 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchitisStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 239,306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development,LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03535558
- Sponsor's protocol ID
- CR108484
- Other IDs
- RRA-20379
- Status last verified
- Jan 2019
- First submitted
- 14 May 2018
- Last updated
- 29 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluoroquinolone Associated Disability
- ClinicalTrials.gov ID
- NCT03535558
- Acronym / sponsor ID
- CR108484
- Conditions
- Bronchitis, Sinusitis, Urinary Tract Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 239,306 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 17 May 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 24 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: FQ With Uncomplicated Sinusitis or Bronchitis | – | Drug: 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. |
| Cohort 2: FQ With Uncomplicated Acute Urinary Tract Infection | – | Drug: 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 3: AZ with Uncomplicated Acute Sinusitis or Bronchitis | – | Drug: 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 4: ST with Uncomplicated Acute Urinary Tract Infection | – | Drug: Sulfamethoxazole/Trimethoprim (ST) Fixed Dose CombinationA 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluoroquinolone (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. | Drug | Cohort 1: FQ With Uncomplicated Sinusitis or Bronchitis, Cohort 2: FQ With Uncomplicated Acute Urinary Tract Infection |
| Azithromycin (AZ)Participants exposed to an oral AZ will be observed. Participants will not receive any intervention as a part of this study. | Drug | Cohort 3: AZ with Uncomplicated Acute Sinusitis or Bronchitis |
| Sulfamethoxazole/Trimethoprim (ST) Fixed Dose CombinationParticipants exposed to an oral ST will be observed. Participants will not receive any intervention as a part of this study. | Drug | Cohort 4: ST with Uncomplicated Acute Urinary Tract Infection |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development,LLC Clinical Trial study director
Janssen Research & Development, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchitis and Sinusitis, run by Janssen Research & Development, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Disability in Temporal Proximity (time frame: Up to 120 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2019.