Effect of Topical Sinonasal Antibiotics

NCT03935828 | Withdrawn Phase 2 DMC

• 1 other identifier: NMCSD.2018.0060.
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Chronic Rhinosinusitis (Diagnosis); Antibiotic Side Effect

Keywords

chronic rhinosinusitis; topical sinonasal antibiotics; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• SNOT-22

  Patient-centered, validated 22-item questionnaire assessing SinoNasal outcomes

  Baseline, 3-4 weeks after initiation, and at 6-8 months

Secondary Outcomes (3)

• Modified Lund-Kennedy Score

  Baseline and 3-4 weeks after initiation

• Antibiotic Side Effect Questions

  3-4 weeks after initiation

• Final Questions

  6-8 months

Study Arms (2)

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.

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.

Drug: Oral versus topical antibioitics

Interventions

Oral versus topical antibioitics DRUG

Previously described in two arms

Oral Antibiotics; Topical Sinonasal Antibiotics

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Patients less than 18 years of age, and those that have taken an antibiotic regimen in the previous 2 weeks before culture.

Sponsors & Collaborators

• United States Naval Medical Center, San Diego: lead

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Endoscopic sinus scores will be graded by blinded assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Randomized to oral versus topical antibiotics

Study Record Dates

• First Submitted: April 30, 2019
• First Posted: May 2, 2019
• Study Start: June 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: June 1, 2021
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share