Clinical trial NCT05133258: Antibiotic Concentration After Delivery to Middle Ear for Chronic Suppurative Otitis Media
Official title: Measuring Antibiotic Solution Concentration at the Tympanic Membrane Following Self-administration by Patients With Chronic Suppurative Otitis Media
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Suppurative Otitis Media
Keywords: csom
antibiotic resistance
chronic suppurative otitis media
ototopical ciprofloxacin
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2021-11-24
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ten subjects will be accrued locally in the ENT clinic on 4F at tertiary care center Dartmouth-Hitchcock Medical Center in Lebanon, NH, using inclusion/exclusion criteria listed above.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Adult patients greater than or equal to 18 years of age
* Diagnosis of Chronic Suppurative Otitis Media (CSOM)

Exclusion Criteria:

* Atypical presentation of CSOM or atypical anatomy of the ear
* Presence of additional ear pathophysiology beyond CSOM
* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
* Non-English speaking

Primary outcomes:
measure: Concentration of Ciprofloxacin
timeFrame: 3 to 10 days after initial visit
Secondary outcomes:
measure: Patient Compliance to Treatment as measured by Daily Compliance + Symptom Log
timeFrame: Starting after the initial visit, for 10 days
measure: Persistence of Symptoms as measured by Daily Compliance + Symptom Log
timeFrame: Starting after the initial visit, for 10 days. Afterwards, weekly surveys to monitor symptoms for a maximum followup of 12 weeks.
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: James E Saunders, MD
role: PRINCIPAL_INVESTIGATOR
References: