Title: Impact of Ciprofloxacin/Dexamethasone Utilization in Pediatric Tracheostomy Patients Authors: Rachel Dickey, Andrea Gerwin, Stephanie Conrad Background/Purpose: Ciprofloxacin/dexamethasone (cip/dex) is a combination antibiotic and corticosteroid that is available in a topical otic formulation. Current approved indications include the treatment of acute otitis externa and post-tympanostomy tube otorrhea. Cip/dex has been used off-label for reducing granulation tissue formation in pediatric tracheostomy patients by pediatric otolaryngologists for many years despite limited supporting data, mostly anecdotal. With long term use of cip/dex, there is theoretical concern for development of resistance to fluoroquinolone (FQ) antibiotics, such as ciprofloxacin and levofloxacin, the only enteral antibiotic formulations with effective broad-spectrum gram-negative coverage. The purpose of this review is to examine the influence of FQ exposure on antimicrobial resistance in our pediatric tracheostomy patients. Methods: This study is a single center, retrospective review conducted using electronic health records of patients followed by Children’s Hospital at Erlanger between January 1, 2018 and December 31, 2025. Included patients had a tracheostomy and microbiological data available in the EHR. Patients were excluded if they received cip/dex drops via alternative route, were lost to follow up, or had care transferred to another institution. Patients were divided into groups based on history of FQ resistant or sensitive organisms. The primary outcome will evaluate total topical and systemic FQ exposure in patients who received cip/dex drops. Secondary outcomes will include number of respiratory cultures and rate of hospitalizations. Standardization of reported outcomes was achieved by normalizing cip/dex exposure, FQ exposure days, and days of hospitalization to patient tracheostomy days. Results: Preliminary results include 16 patients in the FQ-sensitive cohort and 15 patients in the FQ-resistant cohort. Mean days of cip/dex per tracheostomy day were 0.06 (0-0.34) in FQ-sensitive group as compared to 0.05 (0-0.27) in the FQ-resistant group. The mean days of hospitalization per tracheostomy day were 0.76 (0.06-2.96) in the FQ-sensitive group as compared to 0.75 (0.01-8.42) in the FQ-resistant group. Approximately 56 % of the FQ sensitive group were male as compared to 60% of the FQ resistant group. Mean age (months) at tracheostomy was 8.73 (0.9-23.37) and 8.18 (1.70-29.70) in sensitive group and resistant group, respectively. The average number of cultures in the sensitive group and resistant group were 9.9 (2-34) and 10.9 (6-20). Conclusions: There is a paucity of data on the impact of cip/dex drops on bacterial resistance patterns. The FQ-resistant cohort had more cultures than the FQ-sensitive patients. Patients with FQ-resistance had similar hospitalization days per tracheostomy days and tracheostomy duration when compared to the FQ-sensitive cohort. Both cohorts had similar ratios of systemic FQs and topical cip/dex exposure.
