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

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.

Study Overview

• Status: Completed
• Conditions: Acute Otitis Media
• Intervention / Treatment: Drug: Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension

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 Type: Observational
• Enrollment (Actual): 318

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Worth, Texas, United States, 76134
      • Contact Alcon Call Center for Trial Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 4 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants were selected from medical practices serving pediatric patients.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	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; Other Names: CIPRODEX®
Healthy; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in microbial organism susceptibility and fluoroquinolone resistant flora at sites distal to the original infection.	42 + 10 days

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Gale Cupp, MS, Alcon Research

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (ACTUAL): November 1, 2012
• Study Completion (ACTUAL): November 1, 2012

Study Registration Dates

• First Submitted: December 4, 2009
• First Submitted That Met QC Criteria: December 4, 2009
• First Posted (ESTIMATE): December 8, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): March 18, 2013
• Last Update Submitted That Met QC Criteria: March 14, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: ear tubes; ear infection; ear drops; ear drainage; tympanostomy tubes
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis; Otitis Media; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Dexamethasone; Ciprofloxacin
• Other Study ID Numbers: C-09-017