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Original Investigation
April 2017

Efficacy and Safety of Ciprofloxacin Plus Fluocinolone in Otitis Media With Tympanostomy Tubes in Pediatric PatientsA Randomized Clinical Trial

Author Affiliations
  • 1Center for Pediatric ENT–Head and Neck Surgery, Boynton Beach, Florida
  • 2Otolaryngology Department, Hospital Vall d’Hebron, Barcelona, Spain
  • 3private practice, Johannesburg, South Africa
  • 4Central California Clinical Research, Fresno
  • 5Vital Prospects Clinical Research Institute PC, Tulsa, Oklahoma
  • 6Carolina ENT Clinic (Centri Inc), Orangeburg, South Carolina
  • 7Spartanburg Ear Nose & Throat, North Grove Medical Park, Spartanburg, South Carolina
  • 8Ear, Nose, and Throat, Constantiaberg Medi-Clinic, Cape Town, South Africa
  • 9Greensboro Ear, Nose & Throat, Greensboro, North Carolina
  • 10private practice, Conroe, Texas
  • 11Ear, Nose, and Throat Department, NEA Baptist Clinic, Jonesboro, Arkansas
  • 12Otolaryngology Department, Hospital Quirón, Madrid, Spain
JAMA Otolaryngol Head Neck Surg. 2017;143(4):341-349. doi:10.1001/jamaoto.2016.3537
Key Points

Question  Is the combination of ciprofloxacin plus fluocinolone acetonide otic solution more effective and safer than ciprofloxacin alone and fluocinolone alone to treat acute otitis media with tympanostomy tubes in children?

Findings  In 2 randomized clinical trials with identical designs, which included 662 children with acute otitis media with tympanostomy tubes, ciprofloxacin plus fluocinolone administered for 7 days was compared with their components alone. The cessation of otorrhea occurred 2.7 days sooner with the combination, and the number of related adverse events was small.

Meaning  Ciprofloxacin plus fluocinolone is more effective than treatment with either of the components alone for acute otitis media with tympanostomy tubes and is well tolerated.

Abstract

Importance  Acute otitis media with tympanostomy tubes (AOMT) in children commonly presents with otorrhea and negatively affects their daily activities.

Objective  To evaluate the efficacy and safety of topical ciprofloxacin, 0.3%, plus fluocinolone acetonide, 0.025%, otic solution relative to ciprofloxacin, 0.3%, otic solution alone and fluocinolone acetonide, 0.025%, otic solution alone in the treatment of AOMT in children.

Design, Setting, and Participants  Two twin multicenter, randomized, double-blind clinical trials with identical designs were conducted from June 24, 2011, through June 23, 2014, at ear, nose, and throat pediatric practices, general practices, hospitals, and clinical research centers. The study population comprised 662 children (331 in each trial) with AOMT in at least 1 ear who presented with moderate or severe purulent otorrhea for 3 weeks or less. Data analyses were performed on an intention-to-treat basis.

Interventions  Patients were randomly assigned to receive ciprofloxacin plus fluocinolone, ciprofloxacin alone, or fluocinolone alone twice daily for 7 days and were evaluated on days 1 (baseline), 3 to 5 (undergoing therapy), 8 to 10 (end of therapy), and 18 to 22 (test of cure).

Main Outcomes and Measures  The primary efficacy measure was time to cessation of otorrhea. The principal secondary end point was sustained microbiological cure, defined as eradication or presumed eradication at end-of-therapy and test-of-cure visits.

Results  A total of 662 children participating in the 2 studies were randomized to receive ciprofloxacin plus fluocinolone (n = 223), ciprofloxacin alone (n = 221), or fluocinolone alone (n = 218). The median age was 2.5 years (range, 0.6-12.7 years). The median time to cessation of otorrhea was 4.23 days (95% CI, 3.65-4.95 days) in patients receiving ciprofloxacin plus fluocinolone compared with 6.95 days (95% CI, 5.66-8.20 days) in those receiving ciprofloxacin and not estimable findings in those receiving fluocinolone alone (P < .001). The clinical cure rate at the test-of-cure visit was 80.6% in the ciprofloxacin plus fluocinolone group, 67.4% in the ciprofloxacin group (difference, 13.2%; 95% CI, 5.0%-21.4%; P = .002), and 47.6% in the fluocinolone group (difference, 33.0%; 95% CI, 24.0%-42.0%; P < .001). The sustained microbiological cure rate was 79.7% in the ciprofloxacin plus fluocinolone group vs 67.7% in the ciprofloxacin group (difference, 12.0%; 95% CI, 0.8%-23.0%; P = .04) and 37.6% in the fluocinolone group (difference, 42.1%; 95% CI, 29.3%-54.8%; P < .001). Only 7 (3.1%) of the patients receiving ciprofloxacin plus fluocinolone, 8 (3.6%) of the patients receiving ciprofloxacin, and 10 (4.7%) of the patients receiving fluocinolone presented with adverse events related to study medication.

Conclusions and Relevance  The combination of ciprofloxacin plus fluocinolone is more effective than treatment with ciprofloxacin or fluocinolone alone for AOMT, and it is safe and well tolerated in children.

Trial Registration  clinicaltrials.gov Identifiers: NCT01395966 and NCT01404611

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