NCT03479736

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

A Self-Controlled Case Series Study of Fluoroquinolones Exposure and Collagen-related Serious Adverse Events

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 117,911 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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 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.

Conditions

• Retinal Detachment
• Achilles Tendon
• Aneurysm, Dissecting

Interventions

Type	Name	Description
DRUG	Oral Fluoroquinolones (FQ)	Participants will not receive any intervention as a part of this study. The FQ include all oral forms of FQ (24-hours extended release tablets, extended release tablets, oral solution, oral suspension, oral tablet, pack). The drugs included are ciprofloxacin, gatifloxacin, gemifloxacin, levofloxacin, moxifloxacin, norfloxacin, ofloxacin.
DRUG	Other Antibiotics	Participants will not receive any intervention as a part of this study. Other antibiotics include amoxicillin, azithromycin, trimethoprim and trimethroprim/sulfamethoxazole.
OTHER	Febrile Illness Not Treated with Antibiotics Will be Analyzed as an Exposure	Febrile illness not treated with antibiotics is defined as: concurrent diagnoses of viral disease with concurrent fever, and no concurrent prescription for any antibiotic during the 60-day period before and after the first date of viral disease diagnosis; or a diagnosis of influenza with no concurrent inpatient admission during the 60-day period pre- or post-influenza diagnosis, and no prescription for any antibiotics during the 60-day period pre- or post-influenza diagnosis.

Timeline

• Start date: 2017-11-20
• Primary completion: 2018-05-21
• Completion: 2018-06-04
• First posted: 2018-03-27
• Last updated: 2025-06-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study