Topical Treatment of Acute Otitis Media Through Tympanostomy Tubes (AOMT) and Its Effect on Microbial Flora Distal to the Site of Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 318
- 试验地点
- 1
- 主要终点
- Change in microbial organism susceptibility and fluoroquinolone resistant flora at sites distal to the original infection.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension (Drug)
结局指标
主要结局
Change in microbial organism susceptibility and fluoroquinolone resistant flora at sites distal to the original infection.
时间窗: 42 + 10 days
次要结局
未报告次要终点