Clinical trial: Topical Treatment of Acute Otitis Media Through Tympanostomy Tubes (AOMT) and Its Effect on Microbial Flora (NCT01027494)

Eligibility criteria:
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 infection (other than AOMT) requiring systemic
             antimicrobial therapy;

          -  Known or suspected allergy or hypersensitivity to quinolones;

          -  Other protocol-defined exclusion criteria may apply.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 6 Months old.
Subject must be at most 4 Years

Patient description (medical language): A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear.  Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus.  Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane.  Conduction hearing loss is noted in the left ear.  The remainder of the ear, nose, and throat examination is normal.

Patient description (patient's own words): I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal.

Does the patient match the trial criteria? Contradiction