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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01027494
First received: December 4, 2009
Last updated: March 14, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Acute Otitis Media
Drug: Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension
Phase 3

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Change in microbial organism susceptibility and fluoroquinolone resistant flora at sites distal to the original infection. [ Time Frame: 42 + 10 days ] [ Designated as safety issue: No ]

Enrollment: 318
Study Start Date: December 2009
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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®
Healthy
No intervention

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

Ages Eligible for Study:   6 Months to 4 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Participants were selected from medical practices serving pediatric patients.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01027494

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

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01027494     History of Changes
Other Study ID Numbers: C-09-017
Study First Received: December 4, 2009
Last Updated: March 14, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
Ciprofloxacin
BB 1101
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors

ClinicalTrials.gov processed this record on July 29, 2014