Topical Ofloxacin Treatment of Otorrhea in Children With Tympanostomy Tubes

Dohar, Joseph E.; Garner, Eric T.; Nielsen, Richard W.; Biel, Merril A.; Seidlin, Mindell

doi:10.1001/archotol.125.5.537

Cited by 59 publications

(36 citation statements)

References 15 publications

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“…4,5,16,17 The present study shows that the addition of the corticosteroid dexamethasone to the fluoroquinolone ciprofloxacin achieves superior rates of clinical cure and microbiologic success, results in fewer treatment failures, and provides earlier resolution of AOMT compared with treatment with the single-agent fluoroquinolone ofloxacin. In this regard, the findings confirm our earlier clinical report of ciprofloxacin/dexamethasone versus ciprofloxacin 15 and in experimental animal studies showing that antibiotic/dexamethasone combinations are more effective than antibiotic therapy alone in resolving otorrhea in a primate model of CSOM 14 and in reducing and preventing persistent middle ear mucosal changes in rats with experimental AOM.…”

Section: Discussionmentioning

confidence: 60%

“…15 The present study was designed to evaluate further the efficacy and the safety of the topical ciprofloxacin/ dexamethasone combination by comparing it with the related fluoroquinolone ofloxacin administered alone in children with AOMT. Topical ofloxacin was chosen as the comparator for this study because of its reported efficacy and safety in ear infections, including AOMT, 16,17 CSOM, 18 and acute otitis externa. 19 …”

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confidence: 99%

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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

Roland

Kreisler²,

Reese³

et al. 2004

Pediatrics

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ABSTRACT. 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 >6 months to 12 years with an AOMT episode of <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.Conclusion. Topical ciprofloxacin/dexamethasone treatment is superior to topical ofloxacin in the treatment of AOMT. Pediatrics 2004;113:e40 -e46. URL: http://www. pediatrics.org/cgi/content/full/113/1/e40; ciprofloxacin, dexamethasone, ofloxacin, otorrhea, AOM, tympanostomy tubes.ABBREVIATIONS. AOMT, acute otitis media with otorrhea through tympanostomy tubes; CSOM, chronic suppurative otitis media; TOC, test of cure; ITT, intention-to-treat.T he most common surgery performed in children for treatment of recurrent otitis media with effusion is the insertion of a tympanostomy tube into the eardrum. 1 However, otorrhea is a common complication after their insertion. The vast majority (90%-95%) of cases of acute otitis media with otorrhea through tympanostomy tubes (AOMT) occur in children aged 1 to 12 years, and typically 2 to 6 episodes of AOMT are experienced. 2,3 Topical ciprofloxacin is an effective and safe therapy for AOMT 4,5 and chronic suppurative otitis media (CSOM). 6 -8 Bacteria commonly isolated from patients with AOMT include Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Staphylococcus aureus, and Pseudomonas aeruginosa. 3 Because of the inflammatory response indu...

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Section: Discussionmentioning

confidence: 60%

mentioning

confidence: 99%

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

Roland

Kreisler²,

Reese³

et al. 2004

Pediatrics

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“…Fourteen articles were selected for final review and quality assessment. Of the 14 articles, 11 articles were included in the meta-analysis [5,8,[10][11][12][13][14][15][16][17][18]. One article was excluded because the subjects included in the study were patients with otitis externa [19].…”

Section: Literature Searchmentioning

confidence: 99%

“…Eleven trials [5,8,[10][11][12][13][14][15][16][17][18] were included in the evaluation of the resolution of otorrhea, with a pooled total of 1,266 patients (table 6). All 11 studies showed a higher benefit increase in terms of resolution of otorrhea in patients given 0.3% ofloxacin otic solution.…”

Section: Resolution Of Otorrheamentioning

confidence: 99%

“…All 4 published studies on patients with chronically discharging ear [5,8,17,18] and 2 published trials on patients with draining tympanostomy tubes [11,13] showed a significantly higher benefit increase in overall cure rate and resolution of otorrhea in favor of 0.3% ofloxacin. Three unpublished trials [12,15,16] out of the 4 that reported resolution of otalgia had better results with 0.3% ofloxacin solution than the other published study [18].…”

Section: Outcome Comparison Between Published and Unpublished Studiesmentioning

confidence: 99%

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A Systematic Review of the Effectiveness of Ofloxaxin Otic Solution for the Treatment of Suppurative Otitis Media

Abes¹,

Espallardo²,

Tong³

et al. 2003

ORL

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The objectives of the study were to determine the effectiveness and incidence of adverse events of ofloxacin otic solution for suppurative otitis media compared with other treatments. All randomized controlled trials and nonrandomized comparative clinical trials published from 1966 to 2000 using ofloxacin otic solution as one of the interventions were reviewed and data were extracted and analyzed. Eleven clinical trials (9 randomized and 2 nonrandomized) enrolling 1,484 adults and children were finally included in the analysis. Five studies employed clear concealment procedure in the allocation of treatment whereas evaluation of outcome was at least single-blinded in 6 trials. The probability of overall cure rate was higher with 0.3% ofloxacin otic solution than with other topical or systemic antibiotics in 9 of the studies analyzed (OR = 2.67; 95% CI = 2.04, 3.50). Resolution of secondary outcome parameters evaluated at least 1 week after treatment was higher with 0.3% ofloxacin otic solution: resolution of otalgia (4 trials; OR = 2.41; 95% CI = 1.2, 4.82); resolution of otorrhea (11 trials; OR = 2.78; 95% CI = 2.12, 3.65), and bacterial eradication rate (6 trials; OR = 3.86; 95% CI = 2.54, 5.87). A subgroup analysis of 4 studies comparing ofloxacin otic solution with antibiotic- and steroid-containing otic solution showed a higher cure rate for ofloxacin otic solution (OR = 2.73; 95% CI = 1.52, 4.90). Another subgroup analysis on 3 studies comparing ofloxacin otic solution with oral systemic antibiotics showed higher resolution of otorrhea with ofloxacin otic solution (OR = 2.78; 95% CI = 2.12, 3.65). Of 4 studies with data on adverse events, the probability of adverse events was lower with ofloxacin otic solution than with other topical antibiotics (OR = 0.28; 95% CI = 0.19, 0.42). Subgroup analysis showed that 0.3% ofloxacin otic solution showed better results in terms of overall cure rate, resolution of otorrhea, otalgia, bacterial eradication rate and incidence of adverse events. Whether due to chronic suppurative otitis media (CSOM) or draining tympanostomy tube, the overall cure rate (CSOM OR = 4.86; with tympanostomy tube OR = 2.13) and resolution of otorrhea (CSOM OR = 4.42; with tympanostomy tube OR = 1.66) were likewise in favor of 0.3% ofloxacin otic solution. The studies included in this meta-analysis showed generally homogenous results in all clinical and laboratory outcomes analyzed, except for the evaluation of adverse events. The authors conclude that 0.3% ofloxacin otic solution is better than other otic antibiotic drops and other oral antibiotics in terms of overall cure rate and resolution of secondary outcome parameters. Estimates on the beneficial effects of ofloxacin otic solution are limited to the period of study included in this review.

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Treatment of Chronic Suppurative Otitis Media With Topical Tobramycin and Dexamethasone

Alper¹,

Dohar²,

Gulhan³

et al. 2000

Arch Otolaryngol Head Neck Surg

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Topical Ofloxacin Treatment of Otorrhea in Children With Tympanostomy Tubes

Abstract: Ofloxacin is safe and significantly more effective than treatments used in historical or current practice for acute purulent otorrhea in children with tympanostomy tubes.

Cited by 59 publications

References 15 publications

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

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

A Systematic Review of the Effectiveness of Ofloxaxin Otic Solution for the Treatment of Suppurative Otitis Media

Treatment of Chronic Suppurative Otitis Media With Topical Tobramycin and Dexamethasone

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