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NCT03369717 · ClinicalTrials.gov registry record · Phase 4
Use of Perioperative Antibiotics in Endoscopic Sinus Surgery
A Phase 4 study, sponsored by Montefiore Medical Center.
- Terminated
- Registry status
- Phase 4
- Development phase
- 24
- Enrollment target
NCT03369717: Clinical Trial Phase 4 study, sponsored by Montefiore Medical Center.
NCT03369717 is a Phase 4 study that was terminated before completion, run by Montefiore Medical Center. The registered enrollment target is 24 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03369717, a Phase 4 study, was terminated before completion, sponsored by Montefiore Medical Center.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 24 participants
- Enrollment target
Study Summary
The objective of this study is to determine whether the use of postoperative antibiotics following endoscopic sinus surgery (ESS) decreases postoperative infection rates. This is a multi-institutional prospective study involving Albert Einstein College of Medicine/Montefiore Medical Center, Columbia University Medical Center, Weill Cornell Medical College, Mount Sinai Health System, and New York University Langone Medical Center. The study design will be a multi-institutional prospective randomized controlled trial with parallel random groups assigned to receive postoperative antibiotics or no postoperative antibiotics. The investigators hypothesize that patients who receive postoperative antibiotics will have lower postoperative infection rates and improved postoperative sinonasal symptoms and nasal endoscopy scores.
Primary Outcome
The number/percentage of participants with postoperative infection rate, as assessed by rigid nasal endoscopy in the office and culture of suspected infectious material noted within the paranasal sinuses will be reported. A postoperative infection as defined by having an infection at ANY of the postoperative visits AND detected initially by evidence of purulence on nasal endoscopy will be considered an infection if the culture swab from the site of purulence during that office visit confirms tha
Interventions
- DRUG Amoxi Clavulanate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2018-08-01 |
| Est. Completion | 2020-05-07 |
| Phase | Phase 4 |
Why NCT03369717 stopped before completion
NCT03369717 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Amoxi Clavulanate is the first listed.
NCT03369717 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03369717 about?
NCT03369717 is a clinical study titled "Use of Perioperative Antibiotics in Endoscopic Sinus Surgery". The objective of this study is to determine whether the use of postoperative antibiotics following endoscopic sinus surgery (ESS) decreases postoperative infection rates. This is a multi-institutional prospective study involving Albert Einstein College of Medicine/Montefiore Medical Center, Columbia...
What is the current status of trial NCT03369717?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 24 participants. The study started on 2018-08-01. Estimated completion is 2020-05-07.
What interventions are being tested in trial NCT03369717?
The interventions under investigation include: Amoxi Clavulanate (DRUG).
Who is sponsoring clinical trial NCT03369717?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03369717's enrollment target sits among peer trials
24 1699th of 2000 higher than 276 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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