Status:
COMPLETED
A Study of Fluoroquinolones Exposure and Collagen-Related Serious Adverse Events
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Retinal Detachment
Achilles Tendon
Eligibility:
All Genders
Brief Summary
The purpose of this study is to evaluate whether there is an increased risk of achilles tendon rupture (ATR), retinal detachment (RD) or aortic aneurysm and dissection (AAD) following exposure to fluo...
Eligibility Criteria
Inclusion
- Have evidence of at least 1 instance of Achilles Tendon Rupture (ATR) or Retinal Detachment (RD) or Aortic Aneurysm and Dissection (AAD)
- Have at least 1 exposure to Fluoroquinolones or any of the other antibiotics (amoxicillin, azithromycin, trimethoprim and trimethroprim/sulfamethoxazole) or febrile illness not treated with antibiotic
- Have at least 1 year of continuous enrollment with pharmacy benefits prior to the ATR, RD or AAD
Exclusion
- ATR, AAD and RD cohorts:
- \- Participants who experience the index event while within a time-at-risk window for more than one exposure type. (The exposure types in this study include FQ as a class, amoxicillin, azithromycin, trimethoprim, trimethroprim/sulfamethoxazole, and febrile illness not treated with antibiotics. Events while within a time-at-risk window of two or more exposure types cannot be associated with any one exposure. Participants are therefore excluded from the study)
- For ATR and AAD cohorts:
- Have inherited disorders of connective tissue, specifically: Ehlers-Danlos syndrome, epidermolysis bullosa, Marfan syndrome, osteogenesis imperfecta
- Have an ATR or AAD event prior to index, during the 1-year pre-index period
- For RD cohort:
- Have cataract surgery prior to index
- Have iridotomy or iridectomy prior to index
Key Trial Info
Start Date :
November 20 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 4 2018
Estimated Enrollment :
117911 Patients enrolled
Trial Details
Trial ID
NCT03479736
Start Date
November 20 2017
End Date
June 4 2018
Last Update
June 25 2025
Active Locations (1)
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1
Janssen Investigative Site
Titusville, New Jersey, United States, 08560