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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01027494
Recruitment Status : Completed
First Posted : December 8, 2009
Last Update Posted : March 18, 2013
Information provided by (Responsible Party):
Alcon Research

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.

Condition or disease Intervention/treatment
Acute Otitis Media 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
Actual Enrollment : 318 participants
Observational Model: Case Control
Time Perspective: Prospective
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 Start Date : December 2009
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections
U.S. FDA Resources

Group/Cohort Intervention/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 Name: CIPRODEX®
No intervention

Primary Outcome Measures :
  1. Change in microbial organism susceptibility and fluoroquinolone resistant flora at sites distal to the original infection. [ Time Frame: 42 + 10 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants were selected from medical practices serving pediatric patients.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01027494

United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Study Director: Gale Cupp, MS Alcon Research

Responsible Party: Alcon Research Identifier: NCT01027494     History of Changes
Other Study ID Numbers: C-09-017
First Posted: December 8, 2009    Key Record Dates
Last Update Posted: March 18, 2013
Last Verified: March 2013

Keywords provided by Alcon Research:
ear tubes
ear drainage
ear infection
ear drops
tympanostomy tubes

Additional relevant MeSH terms:
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors