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

CompletedOBSERVATIONAL
Enrollment

117,911

Participants

Timeline

Start Date

November 20, 2017

Primary Completion Date

May 21, 2018

Study Completion Date

June 4, 2018

Conditions
Retinal DetachmentAchilles TendonAneurysm, Dissecting
Interventions
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.

Trial Locations (1)

08560

Janssen Investigative Site, Titusville

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT03479736 - A Study of Fluoroquinolones Exposure and Collagen-Related Serious Adverse Events | Biotech Hunter | Biotech Hunter