Recruiting

Prophylactic Antibiotics

Sponsor:

CHU de Quebec-Universite Laval

Code:

NCT03809312

Conditions

Chronic Sinus Infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Amoxicillin / Clavulanic acid 875mg / 125mg

Placebos

Study Details

Brief 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

Study ID

NCT03809312

Start date

Aug 14, 2019

Status verified date

Jul, 2020

Completion date

Feb, 2021

Anticipated

Primary completion date

Dec, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 18 years old and over able to consent
  • Patients with chronic rhinosinusitis and failure to maximal medical treatment
  • Endoscopic sinus surgery with at least one of the following: maxillary antrostomy, ethmoidectomy, sphenoidotomy and / or frontal sinusotomy

Exclusion Criteria:

  • Antibiotherapy less than 2 weeks before the intervention
  • Penicillin allergy
  • Inability to establish follow-up
  • Open sinus surgery or associated septorhinoplasty (simple septoplasty is not considered an exclusion criterion)
  • Immunodeficiency
  • Cystic fibrosis of the pancreas
  • Pregnancy
  • odontogenic sinusitis
  • Fungal sinusitis
  • Diabetic
  • Ciliary dyskinesia
  • Sinus neoplasia
  • Patient requiring antibiotic prophylaxis for endocarditis

Study Design

Enrollment

134 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Clavulin group with polyps

Group who will receive clavulin after the endoscopic sinus surgery in prophylactic and who have polyps in the surgery

placebo comparator: Placebo group with polyps

Group who will receive placebo after the endoscopic sinus surgery in prophylactic and who have polyps in the surgery

active comparator: Clavulin group without polyps

Group who will receive clavulin after the endoscopic sinus surgery in prophylactic and who haven't polyps in the surgery

placebo comparator: Placebo group without polyps

Group who will receive clavulin after the endoscopic sinus surgery in prophylactic and who haven't polyps in the surgery

Interventions

Amoxicillin / Clavulanic acid 875mg / 125mg

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

Placebos

Placebos BID x 10 days

Primary outcome measure

  • Modified Lund-Kennedy endoscopic score [ Time Frame: 3 months ]
  • Quality of life of patients SNOT-22 [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Simon-Pierre Harvey-Bolduc, DR

418-455-6167simon-pierre.harvey-bolduc.1@ulaval.ca

Marie-Noëlle Corriveau

marie-noelle.corriveau@fmed.ulaval.ca

Locations

Simon-Pierre Harvey-Bolduc

Recruiting

Québec, Canada, G1H0C2

Contacts

Simon-Pierre Harvey-Bolduc, DR

418-455-6167simon-pierre.harvey-bolduc.1@ulaval.ca

More Information

Sponsor

CHU de Quebec-Universite Laval

Last update posted

Jul 14, 2020

Last verified

Jul, 2020

Keywords

  • ESS
  • Prophylactic antibiotics
  • Chronic sinus infection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by CHU de Quebec-Universite Laval on 2020-07-14.