Chronic Sinus InfectionPhase 4NCT03369717
Use of Perioperative Antibiotics in Endoscopic Sinus Surgery
A Phase 4 study testing Amoxi Clavulanate in people with Chronic Sinus Infection, run by Montefiore Medical Center at 1 site in United States.
Trial summary
The objective of this study is to determine whether the use of postoperative antibiotics following endoscopic sinus surgery (ESS) decreases postoperative infection rates. This is a multi-institutional prospective study involving Albert Einstein College of Medicine/Montefiore Medical Center, Columbia University Medical… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Sinus Infection
- What is being tested?
- Amoxi Clavulanate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 7 May 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with Chronic Rhinosinusitis (CRS) with or without nasal polyposis or allergic fungal rhinosinusitis who present to the otolaryngology clinic who have been deemed suitable for bilateral ESS, and are over the age of 18 will be included.
Who cannot join
- Patients with sinonasal tumors, allergies or adverse reactions to all of the antibiotics that will be used in this study (amoxicillin-clavulanate, doxycycline, clarithromycin), immunodeficiency, cystic fibrosis, pregnancy, or diabetes with nasal polyposis (inability to receive systemic steroids) will be excluded, as will patients who lack capacity to provide informed consent. Patients undergoing active treatment for malignancy will be excluded. Patients undergoing unilateral ESS or with nonabsorbable packing placed at the time of surgery will be excluded. Patients who have been on antibiotics within 2 weeks of the surgery date will be excluded. Patients with acute on chronic sinusitis or the presence of purulence at time of surgery will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
The objective of this study is to determine whether the use of postoperative antibiotics following endoscopic sinus surgery (ESS) decreases postoperative infection rates. This is a multi-institutional prospective study involving Albert Einstein College of Medicine/Montefiore Medical Center, Columbia University Medical Center, Weill Cornell Medical College, Mount Sinai Health System, and New York University Langone Medical Center. The study design will be a multi-institutional prospective randomized controlled trial with parallel random groups assigned to receive postoperative antibiotics or no postoperative antibiotics. The investigators hypothesize that patients who receive postoperative antibiotics will have lower postoperative infection rates and improved postoperative sinonasal symptoms and nasal endoscopy scores.
- Conditions
- Chronic Sinus Infection
- Being tested
- Amoxi Clavulanate
- Keywords
- endoscopic sinus surgery, antibiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxi ClavulanateDrug
Postoperative antibiotics
| Study group | Role | What they receive |
|---|---|---|
| Antibiotics | Experimental | To receive postoperative antibiotics Receives: Drug: Amoxi Clavulanate |
| No antibiotics | No intervention | Will not receive any postoperative antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Infection
The number/percentage of participants with postoperative infection rate, as assessed by rigid nasal endoscopy in the office and culture of suspected infectious material noted within the paranasal sinuses will be reported. A postoperative infection as defined by having an infection at ANY of the postoperative visits AND detected initially by evidence of purulence on nasal endoscopy will be considered an infection if the culture swab from the site of purulence during that office visit confirms that there is an actual bacterial source of the infection.
Measured: During all three scheduled postoperative visits: 7-10 days postoperatively; 2-4 weeks postoperatively; 6-8 weeks postoperatively
Secondary outcomes (2)
Postoperative Sino-nasal Outcome Test (SNOT-22) Scores
Postoperative SNOT-22 scores will be summarized for each visit based on patient-reported symptoms. The SNOT-22 is a 22-item questionnaire used to assess the impact of chronic rhinosinusitis (CRS) on a patient's health-related quality of life. Participants are presented with a list of symptoms and social/emotional consequences of rhinosinusitis and asked to rate each problem over the prior 2-week period on a 6-point Likert scale ranging from 0 ("No Problem") to 5 ("Problem as bad as it can be)" yielding an overall possible scoring range of 0-110. Higher scores are indicative of a greater burden CRS-related symptoms. Scores are summarized by study arm using basic descriptive statistics.
Measured: During all three scheduled postoperative visits: 7-10 days postoperatively; 2-4 weeks postoperatively; 6-8 weeks postoperatively
Perioperative Sinus Endoscopy (POSE) Scores
Sinonasal crusting and inflammation was determined using the perioperative sinus endoscopy (POSE) scoring system based on patient-reported symptoms obtained during all three study visits. POSE assigns points to various areas within the nasal passages, based on the presence of certain conditions like crusting, edema, polyps, secretions, etc. For purposes of this study each parameter was scored from 0-2 yielding an overall possible score of 0-10, with higher scores being indicative of more extensive disease severity or surgical extent in the sinuses. Scores are summarized by study arm using basic descriptive statistics.
Measured: During all three scheduled postoperative visits: 7-10 days postoperatively; 2-4 weeks postoperatively; 6-8 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start1 Aug 2018
- Primary completion7 May 2020
- Study completion7 May 2020
Why it stopped: Study terminated early
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Mount Sinai Hospital, New York, NYU Langone Health, Weill Medical College of Cornell University, Columbia University
- Responsible party
- Sponsor
- Investigators
- Nadeem Akbar, MD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03369717
- Sponsor's protocol ID
- 2017-8460
- Status last verified
- Jun 2025
- First submitted
- 6 Dec 2017
- Last updated
- 17 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Perioperative Antibiotics in Endoscopic Sinus Surgery
- ClinicalTrials.gov ID
- NCT03369717
- Acronym / sponsor ID
- 2017-8460
- Conditions
- Chronic Sinus Infection
- Keywords
- endoscopic sinus surgery, antibiotics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated early
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- Mount Sinai Hospital, New York, NYU Langone Health, Weill Medical College of Cornell University, Columbia University
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 7 May 2020 (actual)
- Study completion
- 7 May 2020 (actual)
- First posted
- 12 Dec 2017 (actual)
- Results
- Posted 17 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to determine whether the use of postoperative antibiotics following endoscopic sinus surgery (ESS) decreases postoperative infection rates. This is a multi-institutional prospective study involving Albert Einstein College of Medicine/Montefiore Medical Center, Columbia University Medical Center, Weill Cornell Medical College, Mount Sinai Health System, and New York University Langone Medical Center. The study design will be a multi-institutional prospective randomized controlled trial with parallel random groups assigned to receive postoperative antibiotics or no postoperative antibiotics. The investigators hypothesize that patients who receive postoperative antibiotics will have lower postoperative infection rates and improved postoperative sinonasal symptoms and nasal endoscopy scores.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotics | Experimental | Drug: Amoxi ClavulanateTo receive postoperative antibiotics |
| No antibiotics | No intervention | –Will not receive any postoperative antibiotics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with Chronic Rhinosinusitis (CRS) with or without nasal polyposis or allergic fungal rhinosinusitis who present to the otolaryngology clinic who have been deemed suitable for bilateral ESS, and are over the age of 18 will be included.
Key exclusion criteria (1 listed)
- Patients with sinonasal tumors, allergies or adverse reactions to all of the antibiotics that will be used in this study (amoxicillin-clavulanate, doxycycline, clarithromycin), immunodeficiency, cystic fibrosis, pregnancy, or diabetes with nasal polyposis (inability to receive systemic steroids) will be excluded, as will patients who lack capacity to provide informed consent. Patients undergoing active treatment for malignancy will be excluded. Patients undergoing unilateral ESS or with nonabsorbable packing placed at the time of surgery will be excluded. Patients who have been on antibiotics within 2 weeks of the surgery date will be excluded. Patients with acute on chronic sinusitis or the presence of purulence at time of surgery will be excluded from the study.
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 |
|---|---|---|
| Amoxi ClavulanatePostoperative antibiotics | Drug | Antibiotics |
Primary outcome
Postoperative Infection
Time frame: During all three scheduled postoperative visits: 7-10 days postoperatively; 2-4 weeks postoperatively; 6-8 weeks postoperatively
The number/percentage of participants with postoperative infection rate, as assessed by rigid nasal endoscopy in the office and culture of suspected infectious material noted within the paranasal sinuses will be reported. A postoperative infection as defined by having an infection at ANY of the postoperative visits AND detected initially by evidence of purulence on nasal endoscopy will be considered an infection if the culture swab from the site of purulence during that office visit confirms that there is an actual bacterial source of the infection.
2 secondary outcomes
Postoperative Sino-nasal Outcome Test (SNOT-22) Scores
Time frame: During all three scheduled postoperative visits: 7-10 days postoperatively; 2-4 weeks postoperatively; 6-8 weeks postoperatively
Perioperative Sinus Endoscopy (POSE) Scores
Time frame: During all three scheduled postoperative visits: 7-10 days postoperatively; 2-4 weeks postoperatively; 6-8 weeks postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Chronic Sinus Infection
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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.
Nadeem Akbar, MD principal investigator
Assistant Professor
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 Amoxi Clavulanate in people with Chronic Sinus Infection, run by Montefiore Medical Center at 1 site in United States.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 17 Jun 2025. 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 United States. 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. 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?
Yes. Results are posted in the registry (first posted 17 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Infection (time frame: During all three scheduled postoperative visits: 7-10 days postoperatively; 2-4 weeks postoperatively; 6-8 weeks postoperatively). 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 17 Jun 2025.