Randomized, investigator-blinded, multicenter study of gatifloxacin versus amoxicillin/clavulanate treatment of recurrent and nonresponsive otitis media in children.

Abstract

BACKGROUND:

Decreased susceptibility of pathogens to currently used agents for recurrent otitis media has provided the impetus for identifying new antimicrobial options.

OBJECTIVE:

To compare gatifloxacin with amoxicillin/clavulanate in children with recurrent or nonresponsive acute otitis media (AOM).

METHODS:

Included in this multicenter randomized trial were 413 patients, ranging in age from 6 months to 7 years, who had recurrent AOM (at least 3 episodes in the previous 6 months or 4 episodes in the previous 12 months) and/or had failed antibiotic therapy for AOM within 14 days of enrollment. Diagnosis required evidence of acute inflammation and otoscopic findings of middle ear effusion; baseline tympanocentesis was optional and encouraged. Children were randomly assigned (2:1) to 10 days of oral therapy with gatifloxacin suspension (10 mg/kg of body weight once daily) or amoxicillin/clavulanate suspension (45/6.4 mg/kg/d in 2 divided doses).

RESULTS:

: Clinical cure was obtained in 90.2% (222 of 246) of patients in the gatifloxacin group and 84.3% (102 of 121) of those in the amoxicillin/clavulanate group (95% confidence interval, -1.9-12.9) 3-10 days after treatment ended. Gatifloxacin was associated with higher clinical cure rates than was amoxicillin/clavulanate in children younger than 2 years of age (92.0% versus 80.0%, respectively). Cure rates by pretreatment pathogen in the gatifloxacin and amoxicillin/clavulanate groups were 92.1% (35 of 38) versus 88.9% (16 of 18) for Streptococcus pneumoniae infections and 88.2% (30 of 34) versus 92.3% (12 of 13) for Haemophilus influenzae infections, respectively. Sustained clinical cures 3-4 weeks after treatment ended were obtained in 74.4% (183 of 246) of patients treated with gatifloxacin and 72.7% (88 of 121) of those treated with amoxicillin/clavulanate. Adverse events considered drug-related occurred with similar frequency in the 2 groups. Six patients (2.2%) in the gatifloxacin group and 2 patients (1.5%) in the amoxicillin/clavulanate group developed transient symptoms of mild or moderate arthralgia.

CONCLUSIONS:

In this comparative evaluation of fluoroquinolone therapy in children with AOM, gatifloxacin was similar in clinical efficacy to amoxicillin/clavulanate 45/6.4 mg/kg/d for treatment of recurrent/nonresponsive infections.

• Authors: Xavier Sáez-Llorens, Adib Rodriguez, Adriano Arguedas, Kamal A Hamed, Joanna Yang, Phillip Pierce, Roger Echols
• Journal: The Pediatric infectious disease journal (Pediatr Infect Dis J) Vol. 24 Issue 4 Pg. 293-300 (Apr 2005) ISSN: 0891-3668 [Print] United States
• PMID: 15818287 (Publication Type: Clinical Trial, Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Infective Agents
• Fluoroquinolones
• Amoxicillin-Potassium Clavulanate Combination
• Gatifloxacin

Topics

• Amoxicillin-Potassium Clavulanate Combination (administration & dosage, therapeutic use)
• Anti-Infective Agents (administration & dosage, adverse effects, therapeutic use)
• Child
• Child, Preschool
• Female
• Fluoroquinolones (administration & dosage, adverse effects, therapeutic use)
• Gatifloxacin
• Haemophilus Infections (drug therapy, microbiology)
• Haemophilus influenzae (drug effects)
• Humans
• Infant
• Male
• Otitis Media (drug therapy)
• Pneumococcal Infections (drug therapy, microbiology)
• Recurrence
• Single-Blind Method
• Streptococcus pneumoniae (drug effects)
• Treatment Failure
• Treatment Outcome