Antibiotic Concentration After Delivery to Middle Ear for Chronic Suppurative Otitis Media

NCT05133258 | Completed

• 1 other identifier: STUDY02001093
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Suppurative Otitis Media

Keywords

csom; antibiotic resistance; chronic suppurative otitis media; ototopical ciprofloxacin

Outcome Measures

Primary Outcomes (1)

• Concentration of Ciprofloxacin

  Antibiotic Delivery to the Middle Ear will be measured by Ciprofloxacin concentration Relevant concentration range is 2000 ng/mL to 2,000,000 ng/mL, which are the minimum inhibitory concentration and theoretical maximum concentration, respectively. Measured through LC-MS/MS, aspirate collected 3-10 days after initial visit.

  3 to 10 days after initial visit

Secondary Outcomes (2)

• Patient Compliance to Treatment as measured by Daily Compliance + Symptom Log

  Starting after the initial visit, for 10 days

• Persistence of Symptoms as measured by Daily Compliance + Symptom Log

  Starting after the initial visit, for 10 days. Afterwards, weekly surveys to monitor symptoms for a maximum followup of 12 weeks.

Study Arms (1)

Chronic Suppurative Otitis Media group

Enrolled subjects with persistent otorrhea due to CSOM and prescribed with standard of care (prescription for antibiotic drops from a pharmacy of their choice with specific written instructions for self-administration).

Other: Aspiration of middle ear fluid following standard-of-care delivery of ciprofloxacin and dexamethasone suspension

Interventions

Aspiration of middle ear fluid following standard-of-care delivery of ciprofloxacin and dexamethasone suspension OTHER

Micro-aspirate of middle ear fluid will be taken from participants with a Juhn Tym-Tap specimen trap following standard-of-care delivery of ciprofloxacin 0.3% and dexamethasone 0.1% suspension. Samples will be analyzed to measure antibiotic concentration in the middle ear fluid.

Chronic Suppurative Otitis Media group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Aspirates of middle ear fluid with be collected to investigate antibiotic delivery. Auricular aspirates will be analyzed by reverse-phase liquid chromatography with tandem mass spectrometry to determine concentrations of ciprofloxacin in the middle ear after standard-of-care antibiotic delivery.

Study Officials

• James E Saunders, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Otology / Neurotology

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 24, 2021
• Study Start: July 5, 2022
• Primary Completion: July 14, 2022
• Study Completion: July 14, 2022
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)