Clinical trial NCT01027494: Topical Treatment of Acute Otitis Media Through Tympanostomy Tubes (AOMT) and Its Effect on Microbial Flora
Official title: Topical Treatment of Acute Otitis Media Through Tympanostomy Tubes (AOMT) and Its Effect on Microbial Flora Distal to the Site of Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Otitis Media
Keywords: ear tubes
ear drainage
ear infection
ear drops
tympanostomy tubes
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2009-12-08
Enrollment: 318
Sex: ALL
Minimum age (years): 6
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants were selected from medical practices serving pediatric patients.

Brief 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.

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.

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.

Primary outcomes:
measure: Change in microbial organism susceptibility and fluoroquinolone resistant flora at sites distal to the original infection.
timeFrame: 42 + 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center for Trial Locations
state: Texas
Study officials:
affiliation: Alcon Research
name: Gale Cupp, MS
role: STUDY_DIRECTOR
References: