Skip to main content
OpenTrials
Completed

NCT Number: NCT05133258

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Concentration of Ciprofloxacin

    Time frame: 3 to 10 days after initial visit

    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.

Secondary outcomes

  1. Patient Compliance to Treatment as measured by Daily Compliance + Symptom Log

    Time frame: Starting after the initial visit, for 10 days

    The patient is given a medication and symptoms log to track administration of ototopical ciprofloxacin treatment (3 times per day for 10 days).

  2. Persistence of Symptoms as measured by Daily Compliance + Symptom Log

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

    The patient is given a medication and symptoms log to track status of symptoms, which include ear discomfort, ear discharge, ear fullness, hearing changes, and "other."

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Official study title

Measuring Antibiotic Solution Concentration at the Tympanic Membrane Following Self-administration by Patients With Chronic Suppurative Otitis Media

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 24, 2021
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.