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NCT05133258 · ClinicalTrials.gov registry record
Antibiotic Concentration After Delivery to Middle Ear for Chronic Suppurative Otitis Media
A clinical trial, sponsored by Dartmouth-Hitchcock Medical Center.
- Completed
- Registry status
- 3
- Enrollment target
NCT05133258: Completed study, sponsored by Dartmouth-Hitchcock Medical Center.
NCT05133258 is a clinical trial that has completed, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 3 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05133258 has completed, sponsored by Dartmouth-Hitchcock Medical Center.
- COMPLETED
- Registry status
- 3 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- OTHER Aspiration of middle ear fluid following standard-of-care delivery of ciprofloxacin and dexamethasone suspension
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2022-07-05 |
| Est. Completion | 2022-07-14 |
What the finished NCT05133258 record still lists
NCT05133258 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 3 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Aspiration of middle ear fluid following standard-of-care delivery of ciprofloxacin and dexamethasone suspension is the first listed.
NCT05133258 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05133258 about?
NCT05133258 is a clinical study titled "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...
What is the current status of trial NCT05133258?
This trial is currently completed. The enrollment target is 3 participants. The study started on 2022-07-05. Estimated completion is 2022-07-14.
What interventions are being tested in trial NCT05133258?
The interventions under investigation include: Aspiration of middle ear fluid following standard-of-care delivery of ciprofloxacin and dexamethasone suspension (OTHER).
Who is sponsoring clinical trial NCT05133258?
This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.
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