Topical Treatment of Acute Otitis Media Through Tympanostomy Tubes (AOMT) and Its Effect on Micro… (NCT01027494) | Clinical Trial Compass
CompletedNot Applicable
Topical Treatment of Acute Otitis Media Through Tympanostomy Tubes (AOMT) and Its Effect on Microbial Flora
United States318 participantsStarted 2009-12
Plain-language 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.
Who can participate
Age range
6 Months – 4 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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);
* 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 infe…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in microbial organism susceptibility and fluoroquinolone resistant flora at sites distal to the original infection.