Effect of Topical Sinonasal Antibiotics

Phase 2

• Conditions: Antibiotic Side Effect; Chronic Rhinosinusitis (Diagnosis)
• Interventions: Drug: Oral versus topical antibioitics

• Registration Number: NCT03935828
• Lead Sponsor: United States Naval Medical Center, San Diego

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-04
• Study First Submitted: 2019-04-30
• Study First Submitted QC: 2019-04-30
• Last Update Submitted: 2019-04-30
• Study First Posted: 2019-05-02
• Last Update Posted: 2019-05-02
• Study Start: 2019-06
• Primary Completion: 2020-12
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Topical Sinonasal Antibiotics	Oral versus topical antibioitics	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.
Oral Antibiotics	Oral versus topical antibioitics	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.

Primary Outcome Measures

Name	Time	Method
SNOT-22	Baseline, 3-4 weeks after initiation, and at 6-8 months	Patient-centered, validated 22-item questionnaire assessing SinoNasal outcomes

Secondary Outcome Measures

Name	Time	Method
Modified Lund-Kennedy Score	Baseline and 3-4 weeks after initiation	Endoscopic grading score of sinonasal inflammation
Final Questions	6-8 months	Asking about recurrence of infections, further need for antibiotics and surgeries
Antibiotic Side Effect Questions	3-4 weeks after initiation	Asking about adverse side effects