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Completed

NCT Number: NCT03479736

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

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.

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Key information

Conditions

Retinal Detachment Achilles Tendon Acute Aortic Syndrome Aneurysm Aneurysm, Dissecting Aortic Diseases Aortic Dissection Cardiovascular Diseases Dissection, Blood Vessel Eye Diseases Retinal Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Janssen Investigative Site

Titusville, New Jersey, 08560, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral Fluoroquinolones (FQ)

Drug

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.

Other Antibiotics

Drug

Participants will not receive any intervention as a part of this study. Other antibiotics include amoxicillin, azithromycin, trimethoprim and trimethroprim/sulfamethoxazole.

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

Other

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.

Primary outcomes

  1. Number of Events Resulting From Collagen-Related Disorders Achilles Tendon Rupture (ATR), Retinal Detachment (RD) and Aortic Aneurysm and Dissection (AAD) by Exposure to Fluoroquinolones (FQ)

    Time frame: Approximately up to 6 years

    Participants will be having ATR if they receive a diagnosis for ATR and 1 of the following: tenotomy/primary ruptured AT repair (with/without graft) within 7 days of diagnosis. Participants will be having RD if they receive a diagnosis of RD and a procedure for RD, e.g.: sclera buckle, vitrectomy, retinopexy, retinal cryotherapy, silicone oil fill, air gas fluid exchange or pneumatic retinopexy, within 14 days of index (earlier date of diagnosis/procedure). Participants will be having AAD if they receive a diagnosis for aortic aneurysm, aortic rupture/dissection and an aortic repair surgical procedure concurrently to it, in an inpatient/ED setting. The FQ include all oral forms of FQ (ciprofloxacin, gatifloxacin, gemifloxacin, levofloxacin, moxifloxacin, norfloxacin, ofloxacin). Relative risk of RD, ATR, and AAD between periods of exposure and non-exposure to FQ will be assessed using number of events. Temporal associations between RD, ATR or AAD and exposure to FQ will be estimated.

  2. Number of Events Resulting From Collagen-Related Disorders ATR, RD and AAD by Exposure to Other Antibiotics

    Time frame: Approximately up to 6 years

    Other antibiotics includes amoxicillin, azithromycin, trimethoprim and trimethroprim/sulfamethoxazole. Relative risk of RD, ATR, and AAD between periods of exposure and non-exposure to other antibiotics will be assessed using number of events. Temporal associations between RD, ATR or AAD and exposure to other antibiotics will be estimated.

  3. Number of Events Resulting From Collagen-Related Disorders ATR, RD and AAD by Febrile Illness Not Treated With Antibiotics

    Time frame: Approximately up to 6 years

    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. Relative risk of RD, ATR, and AAD between periods of exposure and non-exposure to febrile illness not treated with antibiotics will be assessed using number of events. Temporal associations between RD, ATR or AAD and febrile illness not treated with antibiotics (analyzed as an exposure) will be estimated.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 27, 2018
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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