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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 is a clinical trial that has completed, run by Janssen Research & Development. The registered enrollment target is 117,911 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03479736
The ClinicalTrials.gov registry entry for NCT03479736 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 117,911 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Oral Fluoroquinolones (FQ) is the first listed.
NCT03479736 reports 0 study locations.
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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