Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03535558 · ClinicalTrials.gov registry record
Fluoroquinolone Associated Disability
A clinical trial, sponsored by Janssen Research & Development.
- Completed
- Registry status
- 239,306
- Enrollment target
NCT03535558: Completed study, sponsored by Janssen Research & Development.
NCT03535558 is a clinical trial that has completed, run by Janssen Research & Development. The registered enrollment target is 239,306 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03535558 has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- 239,306 participants
- Enrollment target
Study 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.
Primary Outcome
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)
Interventions
- DRUG Fluoroquinolone (FQ)
- DRUG Azithromycin (AZ)
- DRUG Sulfamethoxazole/Trimethoprim (ST) Fixed Dose Combination
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 239,306 participants |
| Start Date | 2018-05-17 |
| Est. Completion | 2018-12-31 |
What the finished NCT03535558 record still lists
NCT03535558 is an observational study that tracks outcomes without assigning an intervention. Its 239,306 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 3 interventions - of which Fluoroquinolone (FQ) is the first listed.
NCT03535558 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03535558 about?
NCT03535558 is a clinical study titled "Fluoroquinolone Associated Disability". 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 ...
What is the current status of trial NCT03535558?
This trial is currently completed. The enrollment target is 239,306 participants. The study started on 2018-05-17. Estimated completion is 2018-12-31.
What interventions are being tested in trial NCT03535558?
The interventions under investigation include: Fluoroquinolone (FQ) (DRUG), Azithromycin (AZ) (DRUG), Sulfamethoxazole/Trimethoprim (ST) Fixed Dose Combination (DRUG).
Who is sponsoring clinical trial NCT03535558?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04735835 · 250,000 participants · NA
Personalized Responses to Dietary Composition Trial 3
- NCT06090578 · 180,000 participants · NA
TabCAT Brain Health Assessment in Primary Care
- NCT02280733 · 300,000 participants
A Real-World Registry of Chronic Wounds and Ulcers
- NCT06694181 · 300,000 participants
Safe and Explainable AI
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI