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

NCT01027494 | Completed

• 1 other identifier: C-09-017
• Study Type: observational
• Target: 318
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Otitis Media

Keywords

ear tubes; ear drainage; ear infection; ear drops; tympanostomy tubes

Outcome Measures

Primary Outcomes (1)

• Change in microbial organism susceptibility and fluoroquinolone resistant flora at sites distal to the original infection.

  42 + 10 days

Study Arms (2)

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

Healthy

No intervention

Interventions

Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension DRUG

Four drops in the outer ear canal of infected ear(s) while awake 2 times per day for 7 days

Also known as: CIPRODEX®

Treatment

Eligibility Criteria

• Age: 6 Months - 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Participants were selected from medical practices serving pediatric patients.

You may qualify if:

• 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);

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Otitis Media; Otitis

Interventions

Ciprofloxacin; Dexamethasone

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Gale Cupp, MS

  Alcon Research

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2009
• First Posted: December 8, 2009
• Study Start: December 1, 2009
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: March 18, 2013

Record last verified: 2013-03

Locations

US (1)