Chronic Suppurative Otitis MediaNCT05133258
Antibiotic Concentration After Delivery to Middle Ear for Chronic Suppurative Otitis Media
An observational study of Chronic Suppurative Otitis Media, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Suppurative Otitis Media
- What is being tested?
- Aspiration of middle ear fluid following standard-of-care delivery of ciprofloxacin and dexamethasone suspension
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2022to 14 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adult patients greater than or equal to 18 years of age
- Diagnosis of Chronic Suppurative Otitis Media (CSOM)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03766
About this study
Official title: Measuring Antibiotic Solution Concentration at the Tympanic Membrane Following Self-administration by Patients With 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.
- Conditions
- Chronic Suppurative Otitis Media
- Being tested
- Aspiration of middle ear fluid following standard-of-care delivery of ciprofloxacin and dexamethasone suspension
- Keywords
- csom, antibiotic resistance, chronic suppurative otitis media, ototopical ciprofloxacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspiration of middle ear fluid following standard-of-care delivery of ciprofloxacin and dexamethasone suspensionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Aspiration of middle ear fluid following standard-of-care delivery of ciprofloxacin and dexamethasone suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 to 10 days after initial visit
Secondary outcomes (2)
Patient Compliance to Treatment as measured by Daily Compliance + Symptom Log
The patient is given a medication and symptoms log to track administration of ototopical ciprofloxacin treatment (3 times per day for 10 days).
Measured: Starting after the initial visit, for 10 days
Persistence of Symptoms as measured by Daily Compliance + Symptom Log
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."
Measured: Starting after the initial visit, for 10 days. Afterwards, weekly surveys to monitor symptoms for a maximum followup of 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start5 Jul 2022
- Primary completion14 Jul 2022
- Study completion14 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Suppurative Otitis MediaStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James E. Saunders, Dartmouth-Hitchcock Medical Center
- Investigators
- James E Saunders, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05133258
- Sponsor's protocol ID
- STUDY02001093
- Status last verified
- Jul 2023
- First submitted
- 25 Oct 2021
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Antibiotic Solution Concentration at the Tympanic Membrane Following Self-administration by Patients With Chronic Suppurative Otitis Media
- ClinicalTrials.gov ID
- NCT05133258
- Acronym / sponsor ID
- STUDY02001093
- Conditions
- Chronic Suppurative Otitis Media
- Keywords
- csom, antibiotic resistance, chronic suppurative otitis media, ototopical ciprofloxacin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- 14 Jul 2022 (actual)
- Study completion
- 14 Jul 2022 (actual)
- First posted
- 24 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Suppurative Otitis Media group | – | Other: Aspiration of middle ear fluid following standard-of-care delivery of ciprofloxacin and dexamethasone suspensionEnrolled 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Adult patients greater than or equal to 18 years of age
- Diagnosis of Chronic Suppurative Otitis Media (CSOM)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspiration of middle ear fluid following standard-of-care delivery of ciprofloxacin and dexamethasone suspensionMicro-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. | Other | Chronic Suppurative Otitis Media group |
Primary outcome
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.
2 secondary outcomes
Patient Compliance to Treatment as measured by Daily Compliance + Symptom Log
Time frame: Starting after the initial visit, for 10 days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Chronic Suppurative Otitis Media
Not yet recruiting
Acetic Acid Ear Drops Versus 0.3 % Ciprofloxacin for Chronic Suppurative Otitis Media.
Otitis Media Chronic
Not yet recruiting
Does Adding a Fascial Layer to the Cartilage in Tympanoplasty for Large Tympanic Membrane Perforation Affect the Overall Results?
Tympanic Membrane Perforation, Otitis Media
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James E Saunders, MD principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Suppurative Otitis Media, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of Ciprofloxacin (time frame: 3 to 10 days after initial visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.