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

Acute Otitis Media Clinical Trial

Official title:

Topical Treatment of Acute Otitis Media Through Tympanostomy Tubes (AOMT) and Its Effect on Microbial Flora Distal to the Site of Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01027494
• Other study ID #: C-09-017
• Status: Completed
• Phase: Phase 3
• First received: December 4, 2009
• Last updated: March 14, 2013
• Start date: December 2009
• Est. completion date: November 2012

Study information

• Verified date: March 2013
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 318
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 4 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Otitis Media
• Otitis
• Otitis Media

Intervention

Drug:
• Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension
Four drops in the outer ear canal of infected ear(s) while awake 2 times per day for 7 days

Locations

Country	Name	City	State
United States	Contact Alcon Call Center for Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in microbial organism susceptibility and fluoroquinolone resistant flora at sites distal to the original infection.		42 + 10 days	No