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The Use of Prophylactic Antibiotics in Endoscopy Sinus Surgery for Chronic Rhinosinusitis With or Without Polyp

NCT03809312 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2020-07-14

No results posted yet for this study

Summary

This is a randomized, double-blind clinical trial on the prophylactic use of antibiotics in postoperative endoscopic sinus vs placebo surgery. Patients with chronic rhinosinusitis with or without polyps who have consented to endoscopic sinus surgery according to Canadian practice guidelines may be included in the study after approval by the Research Ethics Board of the University Hospital Center. Quebec and signature of consent.

Conditions

  • Chronic Sinus Infection

Interventions

DRUG

Amoxicillin / Clavulanic acid 875mg / 125mg

Amoxicillin / Clavulanic acid 875 mg / 125 mg BID x 10 days

DRUG

Placebos

Placebos BID x 10 days

Sponsors & Collaborators

  • CHU de Quebec-Universite Laval

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-14
Primary Completion
2020-12-31
Completion
2021-02-28

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03809312 on ClinicalTrials.gov