Chronic Sinus InfectionPhase 4NCT03809312
The Use of Prophylactic Antibiotics in Endoscopy Sinus Surgery for Chronic Rhinosinusitis With or Without Polyp
A Phase 4 study testing Amoxicillin / Clavulanic acid 875mg / 125mg in people with Chronic Sinus Infection, run by CHU de Quebec-Universite Laval at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Sinus Infection
- What is being tested?
- Amoxicillin / Clavulanic acid 875mg / 125mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 1 siteCanada
- Study dates
- 14 Aug 2019to Feb 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- Pregnancy
- odontogenic sinusitis
- Fungal sinusitis
- Diabetic
- Ciliary dyskinesia
- Sinus neoplasia
- Patient requiring antibiotic prophylaxis for endocarditis
Trial locations and contacts
1 site in 1 country.
Marie-Noëlle Corriveau contact
Canada1 site, 1 recruiting
- Recruiting
Simon-Pierre Harvey-Bolduc
Québec, G1H0C2
Simon-Pierre Harvey-Bolduc, DR, 418-455-6167, simon-pierre.harvey-bolduc.1@ulaval.ca
About this study
Official title: The Use of Prophylactic Antibiotics in Endoscopy Sinus Surgery for Chronic Rhinosinusitis With or Without Polyp: A Randomized, Double-blind Clinical Trial
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.
Read the 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.
- Conditions
- Chronic Sinus Infection
- Being tested
- Amoxicillin / Clavulanic acid 875mg / 125mg, Placebos
- Keywords
- ESS, Prophylactic antibiotics, Chronic sinus infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxicillin / Clavulanic acid 875mg / 125mgDrug
Amoxicillin / Clavulanic acid 875 mg / 125 mg BID x 10 days
PlacebosDrug
Placebos BID x 10 days
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 3 months
Secondary outcomes (7)
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
Measured: 1 months
Rate of infection
Evaluate the rate of infection after endoscopic sinus surgery with or without prophylactic antibiotics, defined according to the criteria of acute bacterial rhinosinusitis.
Measured: 3 months
VAS symptoms
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.
Measured: 3 months
Side effects
Compare side effects when using prophylactic antibiotics after endoscopic sinus surgery for chronic rhinosinusitis versus placebo.
Measured: 3 months
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
Measured: 6 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.
Measured: 1 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start14 Aug 2019
- Primary completionDec 2020 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Sinus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon-Pierre Harvey-Bolduc, CHU de Quebec-Universite Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03809312
- Sponsor's protocol ID
- ATBprophylacticCES
- Status last verified
- Jul 2020
- First submitted
- 15 Jan 2019
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Prophylactic Antibiotics in Endoscopy Sinus Surgery for Chronic Rhinosinusitis With or Without Polyp: A Randomized, Double-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT03809312
- Acronym / sponsor ID
- ATBprophylacticCES
- Conditions
- Chronic Sinus Infection
- Keywords
- ESS, Prophylactic antibiotics, Chronic sinus infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Study start
- 14 Aug 2019 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 18 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- 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
| Arm | Type | Receives |
|---|---|---|
| Clavulin group with polyps | Active comparator | Drug: Amoxicillin / Clavulanic acid 875mg / 125mgGroup who will receive clavulin after the endoscopic sinus surgery in prophylactic and who have polyps in the surgery |
| Placebo group with polyps | Placebo comparator | Drug: PlacebosGroup who will receive placebo after the endoscopic sinus surgery in prophylactic and who have polyps in the surgery |
| Clavulin group without polyps | Active comparator | Drug: Amoxicillin / Clavulanic acid 875mg / 125mgGroup who will receive clavulin after the endoscopic sinus surgery in prophylactic and who haven't polyps in the surgery |
| Placebo group without polyps | Placebo comparator | Drug: PlacebosGroup who will receive clavulin after the endoscopic sinus surgery in prophylactic and who haven't polyps in the surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amoxicillin / Clavulanic acid 875mg / 125mgAmoxicillin / Clavulanic acid 875 mg / 125 mg BID x 10 days | Drug | Clavulin group with polyps, Clavulin group without polyps |
| PlacebosPlacebos BID x 10 days | Drug | Placebo group with polyps, Placebo group without polyps |
Primary outcome
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
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.
7 secondary outcomes
Modified Lund-Kennedy endoscopic score
Time frame: 1 months
Rate of infection
Time frame: 3 months
VAS symptoms
Time frame: 3 months
Side effects
Time frame: 3 months
Modified Lund-Kennedy endoscopic score
Time frame: 6 months
Quality of life of patients SNOT-22
Time frame: 1 months
Quality of life of patients SNOT-22
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Noëlle Corriveau contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amoxicillin / Clavulanic acid 875mg / 125mg in people with Chronic Sinus Infection, run by CHU de Quebec-Universite Laval at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simon-Pierre Harvey-Bolduc, DR (418-455-6167, simon-pierre.harvey-bolduc.1@ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Lund-Kennedy endoscopic score (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.