Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 18 of 26 for:    "Sinusitis" | "Clavulanate"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03809312
Recruitment Status : Not yet recruiting
First Posted : January 18, 2019
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Simon-Pierre Harvey-Bolduc, CHU de Quebec-Universite Laval

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.

Condition or disease Intervention/treatment Phase
Chronic Sinus Infection Drug: Amoxicillin / Clavulanic acid 875mg / 125mg Drug: Placebos Phase 4

Detailed Description:

The severity of the disease will be evaluated preoperatively according to the SNOT-22 score, the visual analogue scale of nasal symptoms, the Lund-Mackay score on the CT-scan and the Modified Lund-Kennedy endoscopic score (sinusoscopy will be recorded). Relevant demographics and medical history of participants will also be collected preoperatively.

The extension of the CES and intraoperative findings will be noted. Patients who have an infection during the procedure (pus with positive culture) will be excluded from the study. 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 provide either a prescription of Clavulin 875 mg per os twice daily for 10 days, or a placebo of similar visual appearance in the same dosage. A bioabsorbable dressing (NasoPore, Stryker) will be positioned at the mid-meatus level at the end of the procedure. Nasal irrigations of saline solution will be prescribed post-operatively (qid for 1 month) as well as intra-nasal corticosteroids bid after 1 week (usual treatment). The addition of systemic corticosteroids will be left to the judgment of the surgeon, noted and analyzed as a confounding factor.

Follow-up will be done at 2 weeks, 1 month, 3 months and 6 months post-surgery. Patients will have to complete the SNOT-22 quality of life score and the visual similar scale of nasal symptoms at each visit. Sinusoscopy will be recorded at scheduled visits postoperatively. A single blind evaluator (to limit inter-rater differences) will analyze the video recordings to establish the modified Lund-Kennedy endoscopic score for each patient. Middle-meat secretion culture will be performed if pus is present during sinusoscopy and an antibiotic prescribed if needed. The patient will have to fill in a diary of other medications (analgesics, narcotics, anti-inflammatories) as well as a diary of side effects that will be collected at the visit of a post-operative month.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Randomisation by the pharmacy, no one in the investigator and the participant will know the intervention
Primary Purpose: Prevention
Official Title: The Use of Prophylactic Antibiotics in Endoscopy Sinus Surgery for Chronic Rhinosinusitis With or Without Polyp: A Randomized, Double-blind Clinical Trial
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Drug: Amoxicillin / Clavulanic acid 875mg / 125mg
Amoxicillin / Clavulanic acid 875 mg / 125 mg BID x 10 days

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
Drug: Placebos
Placebos BID x 10 days

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

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
Drug: Placebos
Placebos BID x 10 days




Primary Outcome Measures :
  1. Modified Lund-Kennedy endoscopic score [ Time Frame: 3 months ]
    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

  2. Quality of life of patients SNOT-22 [ Time Frame: 3 months ]
    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.


Secondary Outcome Measures :
  1. Modified Lund-Kennedy endoscopic score [ Time Frame: 1 months ]
    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

  2. Rate of infection [ Time Frame: 3 months ]
    Evaluate the rate of infection after endoscopic sinus surgery with or without prophylactic antibiotics, defined according to the criteria of acute bacterial rhinosinusitis.

  3. VAS symptoms [ Time Frame: 3 months ]
    The visual analogue scale is a scale containing 6 rhinological symptoms. On a 10 centimeter scale, the patient will write the important of his symptoms, 10 being the maximum and 0 the minimum.

  4. Side effects [ Time Frame: 3 months ]
    Compare side effects when using prophylactic antibiotics after endoscopic sinus surgery for chronic rhinosinusitis versus placebo.

  5. Modified Lund-Kennedy endoscopic score [ Time Frame: 6 months ]
    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

  6. Quality of life of patients SNOT-22 [ Time Frame: 1 months ]
    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.

  7. Quality of life of patients SNOT-22 [ Time Frame: 6 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03809312


Contacts
Layout table for location contacts
Contact: Simon-Pierre Harvey-Bolduc, DR 418-455-6167 simon-pierre.harvey-bolduc.1@ulaval.ca
Contact: Marie-Noëlle Corriveau marie-noelle.corriveau@fmed.ulaval.ca

Locations
Layout table for location information
Canada
Simon-Pierre Harvey-Bolduc Not yet recruiting
Québec, Canada, G1H0C2
Contact: Simon-Pierre Harvey-Bolduc, DR    418-455-6167    simon-pierre.harvey-bolduc.1@ulaval.ca   
Sponsors and Collaborators
CHU de Quebec-Universite Laval

Layout table for additonal information
Responsible Party: Simon-Pierre Harvey-Bolduc, ENT resident, CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT03809312     History of Changes
Other Study ID Numbers: ATBprophylacticCES
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Simon-Pierre Harvey-Bolduc, CHU de Quebec-Universite Laval:
ESS
Prophylactic antibiotics
Chronic sinus infection

Additional relevant MeSH terms:
Layout table for MeSH terms
Sinusitis
Clavulanic Acids
Clavulanic Acid
Amoxicillin-Potassium Clavulanate Combination
Chronic Disease
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes
Anti-Bacterial Agents
Amoxicillin
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
beta-Lactamase Inhibitors