Safety and Efficacy of Intratympanic Ciprofloxacin Otic Suspension in Children With Middle Ear Effusion Undergoing Tympanostomy Tube Placement
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چکیده
منابع مشابه
Phase 3 Trials of Thermosensitive Ciprofloxacin Gel for Middle Ear Effusion in Children with Tubes
OBJECTIVE To investigate the efficacy, safety, and microbiology of a thermosensitive otic suspension of ciprofloxacin (OTO-201) in children with bilateral middle ear effusion undergoing tympanostomy tube placement. STUDY DESIGN Two randomized, double-blind, sham-controlled phase 3 trials. Patients were randomized to intratympanic OTO-201 or sham. SETTING Children with bilateral middle ear e...
متن کاملOne third of middle ear effusions from children undergoing tympanostomy tube placement had multiple bacterial pathogens
BACKGROUND Because previous studies have indicated that otitis media may be a polymicrobial disease, we prospectively analyzed middle ear effusions of children undergoing tympanostomy tube placement with multiplex polymerase chain reaction for four otopathogens. METHODS Middle ear effusions from 207 children undergoing routine tympanostomy tube placement were collected and were classified by ...
متن کاملOtorrhea in young children after tympanostomy-tube placement for persistent middle-ear effusion: prevalence, incidence, and duration.
OBJECTIVE To characterize the occurrence of tube otorrhea after tympanostomy-tube placement (TTP) for persistent middle-ear effusion (MEE) in a group of otherwise healthy infants and young children. METHODS In a long-term, prospective study of child development in relation to early-life otitis media, we enrolled by 2 months of age healthy infants who presented for primary care at 1 of 2 urban...
متن کاملRandomized Clinical Trial of a Sustained-Exposure Ciprofloxacin for Intratympanic Injection During Tympanostomy Tube Surgery
OBJECTIVE This exploratory clinical trial evaluated the safety and clinical activity of a novel, sustained-exposure formulation of ciprofloxacin microparticulates in poloxamer (OTO-201) administered during tympanostomy tube placement in children. METHODS Double-blind, randomized, prospective, placebo- and sham-controlled, multicenter Phase 1b trial in children (6 months to 12 years) with bila...
متن کاملTopical ciprofloxacin/dexamethasone otic suspension is superior to ofloxacin otic solution in the treatment of children with acute otitis media with otorrhea through tympanostomy tubes.
OBJECTIVE To determine the efficacy and safety of topical ciprofloxacin/dexamethasone otic suspension compared with ofloxacin otic solution in the treatment of acute otitis media with otorrhea through tympanostomy tubes (AOMT) in pediatric patients. METHODS This multicenter, prospective, randomized, observer-masked, parallel-group study was conducted at 39 sites in 599 children aged >or=6 mon...
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ژورنال
عنوان ژورنال: JAMA Otolaryngology–Head & Neck Surgery
سال: 2016
ISSN: 2168-6181
DOI: 10.1001/jamaoto.2016.0001