Effect of Topical Sinonasal Antibiotics

Sponsor

United States Naval Medical Center, San Diego (U.S. Fed)

Overall Status

Unknown status

CT.gov ID

NCT03935828

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Rhinosinusitis (Diagnosis) Antibiotic Side Effect	Drug: Oral versus topical antibioitics	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized to oral versus topical antibioticsRandomized to oral versus topical antibiotics

Masking:

Single (Outcomes Assessor)

Masking Description:

Endoscopic sinus scores will be graded by blinded assessor

Primary Purpose:

Treatment

Official Title:

Effect of Topical Sinonasal Antibiotics in Post-Surgical Patients With an Acute Exacerbation of Chronic Rhinosinusitis

Anticipated Study Start Date :

Jun 1, 2019

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Topical Sinonasal Antibiotics 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 Previously described in two arms
Active Comparator: Oral Antibiotics 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 Previously described in two arms

Arm

Intervention/Treatment

Experimental: Topical Sinonasal Antibiotics

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

Previously described in two arms

Active Comparator: Oral Antibiotics

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

Previously described in two arms

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

United States Naval Medical Center, San Diego

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

United States Naval Medical Center, San Diego

ClinicalTrials.gov Identifier:

NCT03935828

Other Study ID Numbers:

NMCSD.2018.0060.

First Posted:

May 2, 2019

Last Update Posted:

May 2, 2019

Last Verified:

Apr 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by United States Naval Medical Center, San Diego

chronic rhinosinusitis

topical sinonasal antibiotics

randomized controlled trial

Additional relevant MeSH terms:

Sinusitis

Study Results

No Results Posted as of May 2, 2019