Antibiotic Concentration After Delivery to Middle Ear for Chronic Suppurative Otitis Media
Status:
Not yet recruiting
Trial end date:
2022-04-15
Target enrollment:
Participant gender:
Summary
The study team aims to elucidate the potential role of ototopical antibiotic concentration on
outcomes in patients diagnosed with chronic suppurative otitis media (CSOM). Chronic
suppurative otitis media (CSOM) is characterized by chronic inflammation of the middle ear
with persistent discharge from a non-intact tympanic membrane. CSOM is notably associated
with a significant burden of disease worldwide. Topical fluoroquinolones are first line
therapy for CSOM and are advantageous as compared to oral or intravenous therapy in that
these antibiotics avoid systemic side effects and have the potential to locally deliver high
antibiotic concentrations, which were thought to be sufficient to overcome all bactericidal
resistance to fluoroquinolones.
The investigators will measure antibiotic concentration in aspirates via liquid
chromatography with tandem mass spectrometry (LC-MS/MS) from the middle ear of selected
subjects with CSOM who are prescribed and instructed to self-administer ototopical
ciprofloxacin. Enrolled subjects will be asked to return 3 to 10 days after initial visit to
aspirate the middle ear and receive a follow-up evaluation. Furthermore, the subjects will be
asked to keep logs of their medication use and to administer the ototopical medication one
hour prior to their appointments. The measured ciprofloxacin concentrations will be
correlated with clinical outcomes, primarily the time to symptom resolution. The guiding
hypothesis is that patient self-administration of ciprofloxacin drops vary in antibiotic
delivery with diluted concentrations significantly below the in vitro concentration of the
prescribed solution and that these concentrations are below the bactericidal concentration of
ciprofloxacin-resistant bacteria.