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

NCT03809312 | Unknown Phase 4 DMC

• 1 other identifier: ATBprophylacticCES
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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

Keywords

ESS; Prophylactic antibiotics; Chronic sinus infection

Outcome Measures

Primary Outcomes (2)

• Modified Lund-Kennedy endoscopic score

  The modified Lund-Kennedy score is an endoscopic score that measures sinus involvement during endoscopy. It is divided into 2 nostrils. For each nostril, it has a score of 0 to 2 for the presence of polyp, edema and flow. The score is therefore 0 to 6 for each nostril for a maximum of 12. The higher the score, the more severe is the condition

  3 months

• Quality of life of patients SNOT-22

  The SNOT-22 score is a quality of life score. It contains 22 sinus symptoms. Each of the symptoms is scored from 0 to 5, with 0 being no problem and 5 being a severe problem. The SNOT-22 is a score of 0 to 110, the higher the score, the more severe the disease.

  3 months

Secondary Outcomes (7)

• Modified Lund-Kennedy endoscopic score

  1 months

• Rate of infection

  3 months

• VAS symptoms

  3 months

• Side effects

  3 months

• Modified Lund-Kennedy endoscopic score

  6 months

Study Arms (4)

Clavulin group with polyps

ACTIVE COMPARATOR

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

Drug: Amoxicillin / Clavulanic acid 875mg / 125mg

Placebo group with polyps

PLACEBO COMPARATOR

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

Drug: Placebos

Clavulin group without polyps

ACTIVE COMPARATOR

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

Drug: Amoxicillin / Clavulanic acid 875mg / 125mg

Placebo group without polyps

PLACEBO COMPARATOR

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

Drug: Placebos

Interventions

Amoxicillin / Clavulanic acid 875mg / 125mg DRUG

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

Clavulin group with polyps; Clavulin group without polyps

Placebos DRUG

Placebos BID x 10 days

Placebo group with polyps; Placebo group without polyps

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Antibiotherapy less than 2 weeks before the intervention
• Penicillin allergy
• Inability to establish follow-up
• Immunodeficiency
• Cystic fibrosis of the pancreas
• Pregnancy
• odontogenic sinusitis
• Fungal sinusitis
• Diabetic
• Ciliary dyskinesia
• Sinus neoplasia
• Patient requiring antibiotic prophylaxis for endocarditis

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead

Study Sites (1)

Simon-Pierre Harvey-Bolduc

Québec, G1H0C2, Canada

RECRUITING

MeSH Terms

Interventions

Amoxicillin; Clavulanic Acid

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Clavulanic Acids

Central Study Contacts

Simon-Pierre Harvey-Bolduc, DR

CONTACT

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

Marie-Noëlle Corriveau

CONTACT

marie-noelle.corriveau@fmed.ulaval.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomisation by the pharmacy, no one in the investigator and the participant will know the intervention
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ENT resident

Model Details: During the surgery, 4 groups will be formed as described in the figure below. Patients will be divided according to the presence or absence of polyps at the endoscopy and randomized in one of the 2 groups by the pharmacy of the CHU of Quebec. This will give either a prescription of Clavulin 875 mg per os to be taken twice a day for 10 days, or a placebo of similar visual appearance according to the same dosage

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: January 18, 2019
• Study Start: August 14, 2019
• Primary Completion: December 1, 2020
• Study Completion: February 1, 2021
• Last Updated: July 14, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)