A Study of Fluoroquinolones Exposure and Collagen-Related Serious Adverse Events

Completed

Conditions studied: Retinal Detachment, Achilles Tendon, Aneurysm, Dissecting

In brief

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 fluoroquinolone (FQ) or other antibiotics (amoxicillin, azithromycin, trimethoprim and trimethroprim/sulfamethoxazole) or febrile illness not treated with antibiotics, using a study design that minimizes the impact of confounders not usually captured in health services databases such as heredity or smoking.

Key facts

Study ID

NCT03479736

Run by

Janssen Research & Development, LLC

People needed

117911

Starts

2017-11-20

Expected to finish

2018-06-04

Last updated by the study team

2025-06-25

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Janssen Investigative Site — Titusville, New Jersey, United States

Full record on ClinicalTrials.gov

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