Topical ciprofloxacin is superior to topical saline and systemic antibiotics in the treatment of tympanostomy tube otorrhea in children: the results of a randomized clinical trial.
OBJECTIVE
To compare the clinical failure rates among children with otorrhea through tympanostomy tubes treated with topical or systemic antibiotics versus topical saline.


METHODS
Randomized, double-blind, controlled patient study.


METHODS
A three-armed randomized clinical trial using topical ciprofloxacin or oral amoxicillin or topical saline. The primary outcome was treatment failure defined as presence of otorrhea in at least one ear after 7 days of treatment.


RESULTS
The treatment failure rates were 23% and 70% in the group treated with topical ciprofloxacin and oral amoxicillin, respectively. Treatment failures were seen in 58% of children treated with topical saline. Thus, topical ciprofloxacin significantly reduced treatment failures compared to both oral amoxicillin and topical saline. The most frequent bacteria isolated from treatment failures in general were streptococci and Moraxella catarrhalis.


CONCLUSIONS
The significant effect of topical ciprofloxacin is probably related to a higher local concentration of antibiotics in the middle ear rather than the result of mechanical rinsing and dissolution of the bacterial load.
Heslop
Anders
A
Department of Otorhinolaryngology-Head and Neck Surgery, Aarhus University Hospital, Aarhus, Denmark.
Lildholdt
Torben
T
Gammelgaard
Niels
N
Ovesen
Therese
T
D000284:Administration, Oral; D000287:Administration, Topical; D000658:Amoxicillin / Q000008:administration & dosage*; D000890:Anti-Infective Agents / Q000008:administration & dosage*; D002558:Cerebrospinal Fluid Otorrhea / Q000188:drug therapy* / Q000209:etiology; D002648:Child; D002675:Child, Preschool; D002939:Ciprofloxacin / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D008297:Male; D008876:Middle Ear Ventilation / Q000009:adverse effects* / Q000295:instrumentation; D012189:Retrospective Studies; D016896:Treatment Outcome
D000890:Anti-Infective Agents; D002939:Ciprofloxacin; D000658:Amoxicillin