Multicentre Comparative Study of the Efficacy and Safety of Azithromycin Compared with Amoxicillin/clavulanic Acid in the Treatment of Paediatric Patients with Otitis Media

Overview

Journal Eur J Clin Microbiol Infect Dis

Publisher Springer

Specialties Infectious Diseases
Microbiology

Date 1995 Aug 1

PMID 8565983

Citations 19

Authors

N Principi

Affiliations

Soon will be listed here.

Abstract

An open multicentre study was conducted in 484 children between the ages of 6 months and 12 years with otitis media to compare the efficacy, the safety and the tolerance of once-daily azithromycin given for three days versus thrice-daily amoxicillin/clavulanic acid (CA) given for ten days. A satisfactory response (cure plus improvement) was noted 10 to 14 days after the start of treatment in 199 of 215 (92.6%) azithromycin-treated children and in 186 of 198 (93.9%) amoxicillin/CA-treated children. The relationship between treatment and clinical response was independent of chronicity of infection and the presence or absence of a perforated eardrum. Improvement in signs and symptoms of otitis media occurred significantly more rapidly in the children treated with azithromycin. Treatment-related or possibly treatment-related adverse events were recorded in 11 of 243 (4.5%) azithromycin-treated patients and in 20 of 240 (8.3%) treated with amoxicillin/CA. No patients in the azithromycin treatment group were withdrawn from treatment, but six amoxicillin/CA patients, including two < 2 years of age, discontinued treatment prematurely because of adverse events; the difference between treatment groups was statistically significant (p = 0.0146). It is concluded that azithromycin given as an oral suspension once daily for three days is as safe and effective as amoxicillin/CA given thrice daily for ten days in the treatment of children with otitis media.

Citing Articles

Systemic antibiotics for chronic suppurative otitis media.

Chong L, Head K, Webster K, Dew J, Richmond P, Snelling T Cochrane Database Syst Rev. 2022; 2(2):CD013052.

PMID: 35819801 PMC: 8094871. DOI: 10.1002/14651858.CD013052.pub2.

Topical antibiotics with steroids for chronic suppurative otitis media.

Brennan-Jones C, Chong L, Head K, Burton M, Schilder A, Bhutta M Cochrane Database Syst Rev. 2022; 8:CD013054.

PMID: 35659673 PMC: 8212588. DOI: 10.1002/14651858.CD013054.pub2.

Efficacy and safety of azithromycin and amoxicillin/clavulanate for otitis media in children: a systematic review and meta-analysis of randomized controlled trials.

Dawit G, Mequanent S, Makonnen E Ann Clin Microbiol Antimicrob. 2021; 20(1):28.

PMID: 33894769 PMC: 8070272. DOI: 10.1186/s12941-021-00434-x.

Topical versus systemic antibiotics for chronic suppurative otitis media.

Chong L, Head K, Webster K, Daw J, Richmond P, Snelling T Cochrane Database Syst Rev. 2021; 2:CD013053.

PMID: 33561891 PMC: 8094403. DOI: 10.1002/14651858.CD013053.pub2.

Topical antibiotics for chronic suppurative otitis media.

Brennan-Jones C, Head K, Chong L, Burton M, Schilder A, Bhutta M Cochrane Database Syst Rev. 2020; 1:CD013051.

PMID: 31896168 PMC: 6956124. DOI: 10.1002/14651858.CD013051.pub2.

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