Acute Otitis MediaNCT01027494
Topical Treatment of Acute Otitis Media Through Tympanostomy Tubes (AOMT) and Its Effect on Microbial Flora
An observational study of Acute Otitis Media, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of this observational study was to evaluate the effects of a topical fluoroquinolone (antibiotic) instilled into the otic (ear) canal to treat Acute Otitis Media through Tympanostomy Tubes (AOMT) on selected bacterial species on the skin near the ear, in the nose, and in the throat. Read more about this study
- Who is it for?
- Ages 6 months to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Otitis Media
- What is being tested?
- Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension
- How many people
- 318 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Nov 2012
- 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 6 months to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Participants were selected from medical practices serving pediatric patients.
Who may be able to join
- Six months to less than 5 years of age at time of enrollment;
- Presence of bilateral, patent tympanostomy tubes;
- Otorrhea-free for at least 7 days following tympanostomy tube surgery (healthy group);
- Otorrhea up to and including 21 days in duration in at least one ear at Visit 1 (treatment group);
- Willing to refrain from significant water immersion of both ears without the use of adequate ear protection during swimming, bathing, showering and other water-related activities;
- Read and sign informed consent (parent or guardian);
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Ongoing/current therapy as described in protocol;
- Has received any treatment for current AOMT episode (treatment group);
- Otorrhea greater than 21 days in duration immediately prior to Day 1 visit (treatment group);
- History of or current acute or chronic non-tube otorrhea (through existing perforation of the eardrum);
- Current acute otitis externa (AOE), or malignant otitis externa (MOE) or other conditions which could interfere with evaluation of the study drug;
- Known or suspected ear infection of fungal or mycobacterial origin (treatment group);
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- History or active herpes simplex, vaccina or varicella infections or overt viral infection of the tympanic membrane or the external canal;
- Prior otologic surgery, except that confined to the tympanic membrane, within one year of study entry;
- Diabetes;
- Any current known or suspected infection (other than AOMT) requiring systemic antimicrobial therapy;
- Known or suspected allergy or hypersensitivity to quinolones;
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, 76134
About this study
Official title: Topical Treatment of Acute Otitis Media Through Tympanostomy Tubes (AOMT) and Its Effect on Microbial Flora Distal to the Site of Infection
The purpose of this observational study was to evaluate the effects of a topical fluoroquinolone (antibiotic) instilled into the otic (ear) canal to treat Acute Otitis Media through Tympanostomy Tubes (AOMT) on selected bacterial species on the skin near the ear, in the nose, and in the throat.
Read the detailed description
Pediatric patients with tympanostomy tubes were enrolled into one of two groups: 1) Treatment, i.e., patients with signs of otic infection, to be treated with CIPRODEX; or 2) Healthy, i.e., patients without signs of otic infection, to receive no treatment. Microbiological specimens were collected from four areas (ear canal, skin, nose, throat) during three study visits (Day 1, Day 8, and Day 42), and the specimens collected from the Healthy group served as a comparison (control) group for identifying fluoroquinolone (FQ) resistant bacterial strains.
- Conditions
- Acute Otitis Media
- Being tested
- Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension
- Keywords
- ear tubes, ear drainage, ear infection, ear drops, tympanostomy tubes
- Medical subject headings
- Otitis Media, Otitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspensionDrug
Also called CIPRODEX®
Four drops in the outer ear canal of infected ear(s) while awake 2 times per day for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension, 4 drops in outer ear canal of infected ear(s) while awake 2 times per day for 7 days Receives: Drug: Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension | |
| Healthy | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in microbial organism susceptibility and fluoroquinolone resistant flora at sites distal to the original infection.
Measured: 42 + 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Otitis MediaStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gale Cupp, MS, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01027494
- Sponsor's protocol ID
- C-09-017
- Status last verified
- Mar 2013
- First submitted
- 4 Dec 2009
- Last updated
- 18 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Treatment of Acute Otitis Media Through Tympanostomy Tubes (AOMT) and Its Effect on Microbial Flora Distal to the Site of Infection
- ClinicalTrials.gov ID
- NCT01027494
- Acronym / sponsor ID
- C-09-017
- Conditions
- Acute Otitis Media
- Keywords
- ear tubes, ear drainage, ear infection, ear drops, tympanostomy tubes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 8 Dec 2009 (estimated)
- 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 purpose of this observational study was to evaluate the effects of a topical fluoroquinolone (antibiotic) instilled into the otic (ear) canal to treat Acute Otitis Media through Tympanostomy Tubes (AOMT) on selected bacterial species on the skin near the ear, in the nose, and in the throat.
Detailed description
Pediatric patients with tympanostomy tubes were enrolled into one of two groups: 1) Treatment, i.e., patients with signs of otic infection, to be treated with CIPRODEX; or 2) Healthy, i.e., patients without signs of otic infection, to receive no treatment. Microbiological specimens were collected from four areas (ear canal, skin, nose, throat) during three study visits (Day 1, Day 8, and Day 42), and the specimens collected from the Healthy group served as a comparison (control) group for identifying fluoroquinolone (FQ) resistant bacterial strains.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | – | Drug: Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspensionCiprofloxacin 0.3% and dexamethasone 0.1% otic suspension, 4 drops in outer ear canal of infected ear(s) while awake 2 times per day for 7 days |
| Healthy | – | –No intervention |
Who may qualify
- Ages
- 6 months to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Participants were selected from medical practices serving pediatric patients.
Key inclusion criteria (7 listed)
- Six months to less than 5 years of age at time of enrollment;
- Presence of bilateral, patent tympanostomy tubes;
- Otorrhea-free for at least 7 days following tympanostomy tube surgery (healthy group);
- Otorrhea up to and including 21 days in duration in at least one ear at Visit 1 (treatment group);
- Willing to refrain from significant water immersion of both ears without the use of adequate ear protection during swimming, bathing, showering and other water-related activities;
Key exclusion criteria (12 listed)
- Ongoing/current therapy as described in protocol;
- Has received any treatment for current AOMT episode (treatment group);
- Otorrhea greater than 21 days in duration immediately prior to Day 1 visit (treatment group);
- History of or current acute or chronic non-tube otorrhea (through existing perforation of the eardrum);
- Current acute otitis externa (AOE), or malignant otitis externa (MOE) or other conditions which could interfere with evaluation of the study drug;
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 |
|---|---|---|
| Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspensionAlso: CIPRODEX®Four drops in the outer ear canal of infected ear(s) while awake 2 times per day for 7 days | Drug | Treatment |
Primary outcome
Change in microbial organism susceptibility and fluoroquinolone resistant flora at sites distal to the original infection.
Time frame: 42 + 10 days
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 18 Mar 2013.
Related trials for Acute Otitis Media
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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.
Gale Cupp, MS study director
Alcon Research
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 Acute Otitis Media, run by Alcon Research 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 7 inclusion and 12 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 18 Mar 2013. 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?
Change in microbial organism susceptibility and fluoroquinolone resistant flora at sites distal to the original infection. (time frame: 42 + 10 days). 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 18 Mar 2013.