Chronic Rhinosinusitis (Diagnosis)Phase 2NCT03935828
Effect of Topical Sinonasal Antibiotics
A Phase 2 study testing Oral versus topical antibioitics in people with Chronic Rhinosinusitis (Diagnosis) and Antibiotic Side Effect, run by United States Naval Medical Center, San Diego.
Trial summary
In this study, patients who have had previous endoscopic sinus surgery and present with an acute exacerbation of chronic rhinosinusitis will be offered endoscopic-guided, culture-directed antibiotic therapy. They will then be randomized to receive oral or intranasal topical antibiotics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinosinusitis (Diagnosis), Antibiotic Side Effect
- What is being tested?
- Oral versus topical antibioitics
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2019to Jun 2021
- Phase
- Phase 2
- 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
- Patients who have documented CRS refractory to initial medical management and have undergone sinus surgery (opening of at least one sinus ostium, exclusive of sole balloon dilation), and those with an acute exacerbation of CRS with sinus mucopurulence on exam.
Who cannot join
- Patients less than 18 years of age, and those that have taken an antibiotic regimen in the previous 2 weeks before culture.
About this study
Official title: Effect of Topical Sinonasal Antibiotics in Post-Surgical Patients With an Acute Exacerbation of Chronic Rhinosinusitis
In this study, patients who have had previous endoscopic sinus surgery and present with an acute exacerbation of chronic rhinosinusitis will be offered endoscopic-guided, culture-directed antibiotic therapy. They will then be randomized to receive oral or intranasal topical antibiotics. Both of these are considered standard of care, but there is some limited data suggesting superiority of topical antibiotics especially if guided by culture and in patients who have undergone previous surgery. However, a study that directly compares the two has not been published. Modified Lund-Kennedy endoscopic finding scores and subjective SNOT-22 questionnaires will be collected before and at 3-4 weeks after treatment. Medication-related sided effects will be noted and analyzed. After 6-8 month follow-up, we will analyze the rate of recurrence of exacerbations, need for further antibiotics, need for revision surgery, and SNOT-22 scores based on oral versus topical antibiotic treatment. Our objective is to evaluate both short and long-term response to both oral and topical administration of antibiotics in this patient population in order to determine if either route of administration is superior to the other.
- Being tested
- Oral versus topical antibioitics
- Keywords
- chronic rhinosinusitis, topical sinonasal antibiotics, randomized controlled trial
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral versus topical antibioiticsDrug
Previously described in two arms
| Study group | Role | What they receive |
|---|---|---|
| Topical Sinonasal Antibiotics | Experimental | For topical antibiotics, the compounding pharmacy will use pre-determined doses using data extrapolated from oral and intravenous doses and data that has detailed the effect of the medication on solubility, pH, and particle properties. Provider choice of topical antibiotics includes Mupirocin 0.4mg/ml, Vancomycin 1mg/ml, Tobramycin 0.7mg/ml, Levofloxacin 0.4mg/ml, and Amphotericin B 20mcg/ml, all to be prescribed for 21 days, applied twice a day. Although the dosing schedule for these topical antibiotics has not been definitively studied, the majority of the data supports a range from two to three times daily for three to four weeks. Patients will be instructed by the pharmacist how to dissolve the cream, powder, or vial of antibiotic in saline, and to irrigate each nostril with 120 ml total. Doses will not be varied during the study period. Receives: Drug: Oral versus topical antibioitics |
| Oral Antibiotics | Active comparator | Oral antibiotics will be prescribed for 21 days, as available (albeit limited) evidence recommends antimicrobial therapy in CRS for at least 3 weeks. For oral antibiotics, the choices providers will be given include: Augmentin 500 mg every 12 hours, Cefuroxime 500 mg every 12 hours, Clarithromycin 500 mg every 6 hours, Levofloxacin 500 mg once daily, or Clindamycin 300 mg every 6 hours, as these are standard of care for treatment of Chronic Rhinosinusitis. Receives: Drug: Oral versus topical antibioitics |
What is being measured
The primary outcome is the main question the study is designed to answer.
SNOT-22
Patient-centered, validated 22-item questionnaire assessing SinoNasal outcomes
Measured: Baseline, 3-4 weeks after initiation, and at 6-8 months
Secondary outcomes (3)
Modified Lund-Kennedy Score
Endoscopic grading score of sinonasal inflammation
Measured: Baseline and 3-4 weeks after initiation
Antibiotic Side Effect Questions
Asking about adverse side effects
Measured: 3-4 weeks after initiation
Final Questions
Asking about recurrence of infections, further need for antibiotics and surgeries
Measured: 6-8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study startJun 2019 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionJun 2021 (estimated)
Why it stopped: PI and Record Owner are no longer at our institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis (Diagnosis)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized to oral versus topical antibiotics
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, San Diego
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03935828
- Sponsor's protocol ID
- NMCSD.2018.0060.
- Status last verified
- Jul 2025
- First submitted
- 30 Apr 2019
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Basic, de-identified individual participant data will be made available once all data collection and analysis is complete
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Topical Sinonasal Antibiotics in Post-Surgical Patients With an Acute Exacerbation of Chronic Rhinosinusitis
- ClinicalTrials.gov ID
- NCT03935828
- Acronym / sponsor ID
- NMCSD.2018.0060.
- Keywords
- chronic rhinosinusitis, topical sinonasal antibiotics, randomized controlled trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI and Record Owner are no longer at our institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- United States Naval Medical Center, San DiegoUS federal agency
- Study start
- Jun 2019 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 2 May 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.
In this study, patients who have had previous endoscopic sinus surgery and present with an acute exacerbation of chronic rhinosinusitis will be offered endoscopic-guided, culture-directed antibiotic therapy. They will then be randomized to receive oral or intranasal topical antibiotics. Both of these are considered standard of care, but there is some limited data suggesting superiority of topical antibiotics especially if guided by culture and in patients who have undergone previous surgery. However, a study that directly compares the two has not been published. Modified Lund-Kennedy endoscopic finding scores and subjective SNOT-22 questionnaires will be collected before and at 3-4 weeks after treatment. Medication-related sided effects will be noted and analyzed. After 6-8 month follow-up, we will analyze the rate of recurrence of exacerbations, need for further antibiotics, need for revision surgery, and SNOT-22 scores based on oral versus topical antibiotic treatment. Our objective is to evaluate both short and long-term response to both oral and topical administration of antibiotics in this patient population in order to determine if either route of administration is superior to the other.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized to oral versus topical antibiotics
| Arm | Type | Receives |
|---|---|---|
| Topical Sinonasal Antibiotics | Experimental | Drug: Oral versus topical antibioiticsFor topical antibiotics, the compounding pharmacy will use pre-determined doses using data extrapolated from oral and intravenous doses and data that has detailed the effect of the medication on solubility, pH, and particle properties. Provider choice of topical antibiotics includes Mupirocin 0.4mg/ml, Vancomycin 1mg/ml, Tobramycin 0.7mg/ml, Levofloxacin 0.4mg/ml, and Amphotericin B 20mcg/ml, all to be prescribed for 21 days, applied twice a day. Although the dosing schedule for these topical antibiotics has not been definitively studied, the majority of the data supports a range from two to three times daily for three to four weeks. Patients will be instructed by the pharmacist how to dissolve the cream, powder, or vial of antibiotic in saline, and to irrigate each nostril with 120 ml total. Doses will not be varied during the study period. |
| Oral Antibiotics | Active comparator | Drug: Oral versus topical antibioiticsOral antibiotics will be prescribed for 21 days, as available (albeit limited) evidence recommends antimicrobial therapy in CRS for at least 3 weeks. For oral antibiotics, the choices providers will be given include: Augmentin 500 mg every 12 hours, Cefuroxime 500 mg every 12 hours, Clarithromycin 500 mg every 6 hours, Levofloxacin 500 mg once daily, or Clindamycin 300 mg every 6 hours, as these are standard of care for treatment of Chronic Rhinosinusitis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who have documented CRS refractory to initial medical management and have undergone sinus surgery (opening of at least one sinus ostium, exclusive of sole balloon dilation), and those with an acute exacerbation of CRS with sinus mucopurulence on exam.
Key exclusion criteria (1 listed)
- Patients less than 18 years of age, and those that have taken an antibiotic regimen in the previous 2 weeks before culture.
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 |
|---|---|---|
| Oral versus topical antibioiticsPreviously described in two arms | Drug | Oral Antibiotics, Topical Sinonasal Antibiotics |
Primary outcome
SNOT-22
Time frame: Baseline, 3-4 weeks after initiation, and at 6-8 months
Patient-centered, validated 22-item questionnaire assessing SinoNasal outcomes
3 secondary outcomes
Modified Lund-Kennedy Score
Time frame: Baseline and 3-4 weeks after initiation
Antibiotic Side Effect Questions
Time frame: 3-4 weeks after initiation
Final Questions
Time frame: 6-8 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: No. Basic, de-identified individual participant data will be made available once all data collection and analysis is complete
Related trials for Chronic Rhinosinusitis (Diagnosis)
RecruitingObservational study
Establishing Personalized Phage Therapy and Its Comparative Cost in Difficult-to-treat Infections (EPHICACI)
Musculoskeletal Infection, Chronic Rhinosinusitis (Diagnosis)
RecruitingObservational study
Impact of Sinus Surgery on Individuals With Cystic Fibrosis
Chronic Rhinosinusitis (Diagnosis), Cystic Fibrosis
RecruitingObservational study
Sinus Disease in Young Children With Cystic Fibrosis
Cystic Fibrosis in Children, Cystic Fibrosis
RecruitingPhase 2
Topical Probiotic Sinus Irrigations for Treating Chronic Sinusitis
Chronic Rhinosinusitis (Diagnosis)
Enrolling by invitation
Xylitol vs Saline Nasal Irrigations in CF-CRS
Chronic Rhinosinusitis (Diagnosis)
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral versus topical antibioitics in people with Chronic Rhinosinusitis (Diagnosis) and Antibiotic Side Effect, run by United States Naval Medical Center, San Diego.
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: withdrawn, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
SNOT-22 (time frame: Baseline, 3-4 weeks after initiation, and at 6-8 months). 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 3 Aug 2025; AzTrials last refreshed its copy on 26 Oct 2026.