Topical 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 months to 12 years with an AOMT episode of <or=3 weeks' duration. The mean age of patients was 2.5 years (standard deviation: 2.37 years). Patients received either ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension 4 drops twice daily for 7 days or ofloxacin 0.3% otic solution 5 drops twice daily for 10 days. Clinical signs and symptoms of AOMT were evaluated at clinic visits on days 1 (baseline), 3 (on therapy), 11 (end of therapy), and 18 (test of cure). A patient diary was used to measure time to cessation of otorrhea. Principal pretherapy pathogens included Streptococcus pneumoniae (16.8%), Staphylococcus aureus (13.0%), Pseudomonas aeruginosa (12.7%), Haemophilus influenzae (12.4%), S epidermidis (10.2%), and Moraxella catarrhalis (4.1%).


RESULTS
Ciprofloxacin/dexamethasone is superior to ofloxacin for clinical cure (90% vs 78%) and microbiologic success (92% vs 81.8%) at the test-of-cure visit, produces fewer treatment failures (4.4% vs 14.1%), and results in a shorter median time to cessation of otorrhea (4 days vs 6 days). Ciprofloxacin/dexamethasone treatment is also superior to improvement in clinical response by visit, absence of otorrhea by visit, and reduction of otorrhea volume by visit. Both topical otic preparations are safe and well tolerated in pediatric patients. No change in speech recognition threshold or decrease in hearing from baseline, based on audiometric testing, was noted with either regimen.


CONCLUSIONS
Topical ciprofloxacin/dexamethasone treatment is superior to topical ofloxacin in the treatment of AOMT.
Roland
Peter S
PS
Department of Otolaryngology, University of Texas Southwestern Medical Center, Dallas 75390-9035, USA. Peter.Roland@UTSouthwestern.edu
Kreisler
Leslie S
LS
Reese
Bradley
B
Anon
Jack B
JB
Lanier
Brent
B
Conroy
Peter J
PJ
Wall
G Michael
GM
Dupre
Sheryl J
SJ
Potts
Susan
S
Hogg
Gail
G
Stroman
David W
DW
McLean
Celeste
C
D000208:Acute Disease; D000287:Administration, Topical; D000890:Anti-Infective Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D002939:Ciprofloxacin / Q000009:adverse effects / Q000627:therapeutic use*; D003907:Dexamethasone / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D008876:Middle Ear Ventilation; D015242:Ofloxacin / Q000009:adverse effects / Q000627:therapeutic use*; D010034:Otitis Media with Effusion / Q000188:drug therapy* / Q000382:microbiology; D011446:Prospective Studies; D013535:Suspensions
D000890:Anti-Infective Agents; D000893:Anti-Inflammatory Agents; D013535:Suspensions; D002939:Ciprofloxacin; D003907:Dexamethasone; D015242:Ofloxacin