Antibiotic Side Effect, Chronic Rhinosinusitis (Diagnosis)
Conditions
Keywords
chronic rhinosinusitis, topical sinonasal antibiotics, randomized controlled trial
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.
Interventions
DRUGOral versus topical antibioitics
Previously described in two arms
Sponsors
United States Naval Medical Center, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Endoscopic sinus scores will be graded by blinded assessor
Intervention model description
Randomized to oral versus topical antibiotics
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SNOT-22 | Baseline, 3-4 weeks after initiation, and at 6-8 months | Patient-centered, validated 22-item questionnaire assessing SinoNasal outcomes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed