Loading clinical trials...

A Study of Fluoroquinolones Exposure and Collagen-Related Serious Adverse Events | Clinical Trials | Clareo Health

COMPLETED

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

NCT03479736•Janssen Research & Development, LLC

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.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 Criteria

•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

Locations (1)

Janssen Investigative Site

Titusville, New Jersey, United States

Key Dates

Start Date

November 20, 2017

Primary Completion Date

May 21, 2018

Completion Date

June 4, 2018

Last Updated

June 25, 2025

Enrollment

117,911

ACTUAL participants

Conditions

Retinal DetachmentAchilles TendonAneurysm, Dissecting

Interventions

Oral Fluoroquinolones (FQ)

DRUG

Other Antibiotics

DRUG

Febrile Illness Not Treated with Antibiotics Will be Analyzed as an Exposure

OTHER

Spring Loaded Syringe for Active Silicon Oil Extraction

NCT07363889

Retinal Detachment

View study

RECRUITINGNA

1ry Versus 2ry ILM Peeling in RD

NCT07346560

Retinal Detachment RhegmatogenousILM Peeling

View study

RECRUITINGPHASE4

Dropless Pars Plana Vitrectomy Study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Spring Loaded Syringe for Active Silicon Oil Extraction

1ry Versus 2ry ILM Peeling in RD

Dropless Pars Plana Vitrectomy Study

Restoring Anatomy of Ruptured Achilles Tendon

Prevention of ProliFerative Vitreoretinopathy with Intravitreal MethotreXate in Primary Retinal DEtachment Repair (FIXER) Trial

Swedish Multicenter Trial of Outpatient Prevention of Leg Clots