Clinical trial of ototopical ofloxacin for treatment of chronic suppurative otitis media

Agro, Angelo S.; Garner, Eric T.; Wright, J.William; Escobar, Irma Caballeros de; Villeda, Byron; Seidlin, Mindell

doi:10.1016/s0149-2918(98)80137-9

Cited by 31 publications

(17 citation statements)

References 9 publications

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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%

“…The fluoroquinolone otic preparations have proven to be effective against major pathogens in chronic and acute suppurative otitis media [3][4][5]. Reports indicate that they are also essentially non-ototoxic [6,7].…”

Section: Introductionmentioning

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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Section: Literature Searchmentioning

confidence: 99%

Section: Resolution Of Otorrheamentioning

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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“…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%

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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“…5,6 In addition, almost all of the oral ofloxacin formulations are available only as conventional, immediate-release tablets that require twice daily administration for consecutive days or weeks. [7][8][9] The repeated oral doses of ofloxacin over long time could result in nervous system and gastrointestinal system disorders. 10,11 Efforts have been made to develop alternative formulations of ofloxacin to improve therapeutic efficacy and reduce frequency of administration.…”

Section: Introductionmentioning

confidence: 99%

Preparation and evaluation of ofloxacin-loaded palmitic acid solid lipid nanoparticles

Xie¹,

Zhu²,

Zhao³

et al. 2011

IJN

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The purpose of this study was to use solid lipid nanoparticles (SLN) to improve the pharmacological activity of ofloxacin. Ofloxacin-loaded SLN were prepared using palmitic acid as lipid matrix and poly vinyl alcohol (PVA) as emulsifier by a hot homogenization and ultrasonication method. The physicochemical characteristics of SLN were investigated by optical microscope, scanning electron microscopy, and photon correlation spectroscopy. Pharmacokinetics was studied after oral administration in mice. In vitro antibacterial activity and in vivo antibacterial efficacy of the SLN were investigated using minimal inhibitory concentrations (MIC) and a mouse protection model. The results demonstrated that the encapsulation efficiency, loading capacity, diameter, polydispersivity index, and zeta potential of the nanoparticles were 41.36% ± 1.50%, 4.40% ± 0.16%, 156.33 ± 7.51 nm, 0.26 ± 0.04, and −22.70 ± 1.40 mv, respectively. The SLN showed sustained release and enhanced antibacterial activity in vitro. Pharmacokinetic results demonstrated that SLN increased the bioavailability of ofloxacin by 2.27-fold, and extended the mean residence time of the drug from 10.50 to 43.44 hours. Single oral administrations of ofloxacin-loaded nanoparticles at 3 drug doses, 5 mg/kg, 10 mg/kg, and 20 mg/kg, all produced higher survival rates of lethal infected mice compared with native ofloxacin. These results indicate that SLN might be a promising delivery system to enhance the pharmacological activity of ofloxacin.

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Clinical trial of ototopical ofloxacin for treatment of chronic suppurative otitis media

Cited by 31 publications

References 9 publications

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

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

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

Preparation and evaluation of ofloxacin-loaded palmitic acid solid lipid nanoparticles

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