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Effect of Topical Sinonasal Antibiotics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03935828
Recruitment Status : Not yet recruiting
First Posted : May 2, 2019
Last Update Posted : May 2, 2019
Information provided by (Responsible Party):
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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized 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
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

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

Primary Outcome Measures :
  1. SNOT-22 [ Time Frame: Baseline, 3-4 weeks after initiation, and at 6-8 months ]
    Patient-centered, validated 22-item questionnaire assessing SinoNasal outcomes

Secondary Outcome Measures :
  1. Modified Lund-Kennedy Score [ Time Frame: Baseline and 3-4 weeks after initiation ]
    Endoscopic grading score of sinonasal inflammation

  2. Antibiotic Side Effect Questions [ Time Frame: 3-4 weeks after initiation ]
    Asking about adverse side effects

  3. Final Questions [ Time Frame: 6-8 months ]
    Asking about recurrence of infections, further need for antibiotics and surgeries

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03935828

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Contact: Michael J Coulter, M.D. 618-886-6474

Sponsors and Collaborators
United States Naval Medical Center, San Diego
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Responsible Party: United States Naval Medical Center, San Diego Identifier: NCT03935828    
Other Study ID Numbers: NMCSD.2018.0060.
First Posted: May 2, 2019    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Basic, de-identified individual participant data will be made available once all data collection and analysis is complete

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by United States Naval Medical Center, San Diego:
chronic rhinosinusitis
topical sinonasal antibiotics
randomized controlled trial
Additional relevant MeSH terms:
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Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases