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



Status:Completed
Conditions:Cardiology, Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Ophthalmology
Healthy:No
Age Range:Any
Updated:7/8/2018
Start Date:November 20, 2017
End Date:June 4, 2018

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A Self-Controlled Case Series 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.


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
We found this trial at
1
site
1125 Bear Tavern Road
Titusville, New Jersey 08560
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mi
from
Titusville, NJ
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