Topical ofloxacin versus systemic amoxicillin/clavulanate in purulent otorrhea in children with tympanostomy tubes

Goldblatt, Edward L.; Dohar, Joseph E.; Nozza, Robert J.; Nielsen, Richard W.; Goldberg, Trevor; Sidman, James D.; Seidlin, Mindell

doi:10.1016/s0165-5876(98)00150-5

Cited by 88 publications

(65 citation statements)

References 12 publications

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“…Overall clinical/microbiologic eradication was also not significantly different, 77% for ofloxacin and 67% for amoxicillin/clavulanate. 16 Our study results for ofloxacin demonstrated similar outcomes for clinical cure (78%) and microbiologic eradication (82%) compared with 90% and 92%, respectively, for ciprofloxacin/dexamethasone treatment. …”

supporting

confidence: 59%

“…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: 57%

“…In a prospective, randomized, controlled trial comparing topical otic ofloxacin with oral amoxicillin/clavulanate potassium, no difference was noted between the 2 treatments for overall clinical cure or improvement by visit. 16 Clinical cure rate at the TOC visit was 89% for both treatments. Overall clinical/microbiologic eradication was also not significantly different, 77% for ofloxacin and 67% for amoxicillin/clavulanate.…”

Section: Discussionmentioning

confidence: 90%

“…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 …”

mentioning

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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supporting

confidence: 59%

Section: Discussionmentioning

confidence: 57%

Section: Discussionmentioning

confidence: 90%

mentioning

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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“…[123][124][125] Superior outcomes with topical therapy were achieved in some studies for clinical cure, [123][124][125] bacterial eradication, 124 and patient satisfaction. 124 Rates of clinical cure upon completion of therapy after 7 to 10 days ranged from 77% to 96% with topical therapy and from 30% to 67% with systemic antibiotic therapy. Explanations for improved outcomes with topical antibiotic therapy include increased drug concentration at the site of infection and improved coverage of likely pathogens, Figure 8.…”

Section: Supporting Textmentioning

confidence: 99%

Clinical Practice Guideline: Tympanostomy Tubes in Children

Rosenfeld

Schwartz

Pynnonen

et al. 2013

Otolaryngol.--head neck surg.

332

134

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Objective. Insertion of tympanostomy tubes is the most common ambulatory surgery performed on children in the United States. Tympanostomy tubes are most often inserted because of persistent middle ear fluid, frequent ear infections, or ear infections that persist after antibiotic therapy. Despite the frequency of tympanostomy tube insertion, there are currently no clinical practice guidelines in the United States that address specific indications for surgery. This guideline is intended for any clinician involved in managing children, aged 6 months to 12 years, with tympanostomy tubes or being considered for tympanostomy tubes in any care setting, as an intervention for otitis media of any type.Purpose. The primary purpose of this clinical practice guideline is to provide clinicians with evidence-based recommendations on patient selection and surgical indications for and management of tympanostomy tubes in children. The development group broadly discussed indications for tube placement, perioperative management, care of children with indwelling tubes, and outcomes of tympanostomy tube surgery. Given the lack of current published guidance on surgical indications, the group focused on situations in which tube insertion would be optional, recommended, or not recommended. Additional emphasis was placed on opportunities for quality improvement, particularly regarding shared decision making and care of children with existing tubes.Action Statements. The development group made a strong recommendation that clinicians should prescribe topical antibiotic eardrops only, without oral antibiotics, for children with uncomplicated acute tympanostomy tube otorrhea. The panel made recommendations that (1) clinicians should not perform tympanostomy tube insertion in children with a single episode of otitis media with effusion (OME) of less than 3 months' duration; (2) clinicians should obtain an age-appropriate hearing test if OME persists for 3 months or longer (chronic OME) or prior to surgery when a child becomes a candidate for tympanostomy tube insertion; (3) clinicians should offer bilateral tympanostomy tube insertion to children with bilateral OME for 3 months or longer (chronic OME) and documented hearing difficulties; (4) clinicians should reevaluate, at 3-to 6-month intervals, children with chronic OME who did not receive tympanostomy tubes until the effusion is no longer present, significant hearing loss is detected, or structural abnormalities of the tympanic membrane or middle ear are suspected; (5) clinicians should not perform tympanostomy tube insertion in children with recurrent acute otitis media (AOM) who do not have middle ear effusion in either ear at the time of assessment for tube candidacy; (6) clinicians should offer bilateral tympanostomy tube insertion to children with recurrent AOM who have unilateral or bilateral middle ear effusion at the time of assessment for tube candidacy; (7) clinicians should determine if a child with recurrent AOM or with OME of any duration is at increased risk for sp...

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