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NCT03479736 · ClinicalTrials.gov registry record
A Study of Fluoroquinolones Exposure and Collagen-Related Serious Adverse Events
A clinical trial, sponsored by Janssen Research & Development.
- Completed
- Registry status
- 117,911
- Enrollment target
NCT03479736: Completed study, sponsored by Janssen Research & Development.
NCT03479736 is a clinical trial that has completed, run by Janssen Research & Development. The registered enrollment target is 117,911 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03479736 has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- 117,911 participants
- Enrollment target
Study 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.
Primary Outcome
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 the
Interventions
- DRUG Oral Fluoroquinolones (FQ)
- DRUG Other Antibiotics
- OTHER Febrile Illness Not Treated with Antibiotics Will be Analyzed as an Exposure
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 117,911 participants |
| Start Date | 2017-11-20 |
| Est. Completion | 2018-06-04 |
What the finished NCT03479736 record still lists
NCT03479736 is an observational study that tracks outcomes without assigning an intervention. Its 117,911 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 3 interventions - of which Oral Fluoroquinolones (FQ) is the first listed.
NCT03479736 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03479736 about?
NCT03479736 is a clinical study titled "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/sul...
What is the current status of trial NCT03479736?
This trial is currently completed. The enrollment target is 117,911 participants. The study started on 2017-11-20. Estimated completion is 2018-06-04.
What interventions are being tested in trial NCT03479736?
The interventions under investigation include: Oral Fluoroquinolones (FQ) (DRUG), Other Antibiotics (DRUG), Febrile Illness Not Treated with Antibiotics Will be Analyzed as an Exposure (OTHER).
Who is sponsoring clinical trial NCT03479736?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
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