- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03935828
Effect of Topical Sinonasal Antibiotics
April 30, 2019 updated by: United States Naval Medical Center, San Diego
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.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Michael J Coulter, M.D.
- Phone Number: 618-886-6474
- Email: michael.j.coulter15.mil@mail.mil
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / 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.
|
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.
|
Previously described in two arms
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SNOT-22
Time Frame: Baseline, 3-4 weeks after initiation, and at 6-8 months
|
Patient-centered, validated 22-item questionnaire assessing SinoNasal outcomes
|
Baseline, 3-4 weeks after initiation, and at 6-8 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Modified Lund-Kennedy Score
Time Frame: Baseline and 3-4 weeks after initiation
|
Endoscopic grading score of sinonasal inflammation
|
Baseline and 3-4 weeks after initiation
|
Antibiotic Side Effect Questions
Time Frame: 3-4 weeks after initiation
|
Asking about adverse side effects
|
3-4 weeks after initiation
|
Final Questions
Time Frame: 6-8 months
|
Asking about recurrence of infections, further need for antibiotics and surgeries
|
6-8 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
June 1, 2019
Primary Completion (ANTICIPATED)
December 1, 2020
Study Completion (ANTICIPATED)
June 1, 2021
Study Registration Dates
First Submitted
April 30, 2019
First Submitted That Met QC Criteria
April 30, 2019
First Posted (ACTUAL)
May 2, 2019
Study Record Updates
Last Update Posted (ACTUAL)
May 2, 2019
Last Update Submitted That Met QC Criteria
April 30, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NMCSD.2018.0060.
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Basic, de-identified individual participant data will be made available once all data collection and analysis is complete
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Rhinosinusitis (Diagnosis)
-
Christiane HaaseActive, not recruitingAsthma | Chronic Rhinosinusitis (Diagnosis) | Chronic Rhinosinusitis With Nasal Polyps | Chronic Rhinosinusitis Without Nasal PolypsDenmark
-
Johns Hopkins UniversityGlaxoSmithKlineRecruitingChronic Rhinosinusitis (Diagnosis) | Chronic Rhinosinusitis With Nasal PolypsUnited States
-
Washington University School of MedicineCompletedChronic Rhinosinusitis (Diagnosis) | Allergic Rhinosinusitis | Chronic Eosinophilic RhinosinusitisUnited States
-
Lyra TherapeuticsRecruitingChronic Sinusitis | Chronic Rhinosinusitis (Diagnosis)United States, Poland, Bulgaria, Belgium, Germany, Hungary
-
Medical University of ViennaRecruitingAsthma | Chronic Rhinosinusitis (Diagnosis) | Nasal Polyps | Chronic Rhinosinusitis With Nasal PolypsAustria
-
Sohag UniversityNot yet recruitingRhinosinusitis Chronic | Rhinosinusitis | Fungal Sinusitis | Rhinosinusitis Acute | Allergic Fungal Rhinosinusitis | Intracranial Extension | Invasive Fungal Sinusitis (Diagnosis)Egypt
-
University of California, San FranciscoNational Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health...RecruitingAsthma | Chronic Rhinosinusitis (Diagnosis) | Chronic Rhinosinusitis With Nasal PolypsUnited States
-
Sanna SalmiUniversity of HelsinkiActive, not recruitingChronic Rhinosinusitis (Diagnosis)Finland
-
Oticara Australia PTY LTDRecruitingChronic Rhinosinusitis (Diagnosis)Australia
-
Change Accelerator in Respiratory CareRecruitingChronic Rhinosinusitis (Diagnosis)Belgium, Denmark, Spain, Finland, France, Italy, Austria, Germany, United Kingdom, Netherlands
Clinical Trials on Oral versus topical antibioitics
-
University of Sao PauloCompleted
-
OroScience, Inc.Louisiana State University Health Sciences Center in New OrleansCompletedPain | Oral Surgical ProceduresUnited States
-
Federal University of São PauloUnknown
-
Indonesia UniversityEnrolling by invitationAcne Vulgaris | Vitamin DIndonesia
-
University of SaskatchewanUniversity of Guelph; University of Prince Edward IslandCompletedMuscle WeaknessCanada
-
University of Southern DenmarkHospital of South West JutlandNot yet recruitingRecurrent Urinary Tract Infections | Antibiotic Treatment | Chronic Urinary-catheter-carrier | Biofilm Infection | Replacement of Urinary Catheter
-
Frontier Biotechnologies Inc.CompletedChronic Low Back PainChina
-
North Estonia Medical CentreTartu University HospitalRecruitingAcute Appendicitis | Appendicitis Acute | Appendicitis Perforated | Acute Appendicitis With Rupture | Appendicitis; Perforation | Acute Appendicitis Without Peritonitis | Acute Appendicitis With Appendix AbscessEstonia
-
SanofiRecruitingDermatitis AtopicCanada, United States, Australia, Bulgaria, Czechia, Germany, Hungary, Japan, Poland, Spain, Taiwan, United Kingdom
-
University Hospital Inselspital, BerneCompletedEnd Stage Renal DiseaseSwitzerland