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Bacteriologic and clinical efficacy of amoxicillin/clavulanate vs. azithromycin in acute otitis media.
Pediatr Infect Dis J 2000; 19(2):95-104PI

Abstract

OBJECTIVES

To compare the bacteriologic and clinical efficacy of amoxicillin/clavulanate and azithromycin in patients with acute otitis media (AOM), particularly the ability to eradicate the predominant AOM pathogens from middle ear fluid as assessed by mandatory second tympanocentesis.

METHODS

In this single blind study 238 infants and children with AOM were randomized to receive amoxicillin/clavulanate (45/6.4 mg/kg/day in two divided doses for 10 days) or azithromycin (10 mg/kg on Day 1, then 5 mg/kg daily on Days 2 through 5). Tympanocentesis was performed before the first dose and repeated on Day 4, 5 or 6. Clinical response was assessed at end of therapy between Days 12 and 14 and at follow-up between Days 22 and 28.

RESULTS

Amoxicillin/clavulanate was significantly more likely to eradicate all bacterial pathogens [83% (54 of 65) vs. 49% (35 of 71), P = 0.001] and Haemophilus influenzae [87% (26 of 30) vs. 39% (13 of 33), P = 0.0001] from middle ear fluid than was azithromycin. Amoxicillin/clavulanate was also more likely to eradicate Streptococcus pneumoniae, but the difference was not statistically significant [90% (18 of 20) vs. 68% (13 of 19) [corrected], P = 0.095]. On Days 12 to 14, signs and symptoms were more likely to resolve completely or improve in all culture-positive patients [86% (60 of 70) vs. 70% (51 of 73), P = 0.023] and in those with H. influenzae infections [91% (30 of 33) vs. 65% (22 of 34), P = 0.010] who received amoxicillin/clavulanate compared with those who received azithromycin. Otherwise there were no significant differences between groups in clinical outcomes on Days 12 to 14 or at follow-up.

CONCLUSIONS

Our findings indicate that amoxicillin/clavulanate has superior bacteriologic and clinical efficacy compared with azithromycin in children with AOM.

Authors+Show Affiliations

Soroka University Medical Center and the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel. rdagan@bgumail.bgu.ac.ilNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

10693993

Citation

Dagan, R, et al. "Bacteriologic and Clinical Efficacy of Amoxicillin/clavulanate Vs. Azithromycin in Acute Otitis Media." The Pediatric Infectious Disease Journal, vol. 19, no. 2, 2000, pp. 95-104.
Dagan R, Johnson CE, McLinn S, et al. Bacteriologic and clinical efficacy of amoxicillin/clavulanate vs. azithromycin in acute otitis media. Pediatr Infect Dis J. 2000;19(2):95-104.
Dagan, R., Johnson, C. E., McLinn, S., Abughali, N., Feris, J., Leibovitz, E., ... Jacobs, M. R. (2000). Bacteriologic and clinical efficacy of amoxicillin/clavulanate vs. azithromycin in acute otitis media. The Pediatric Infectious Disease Journal, 19(2), pp. 95-104.
Dagan R, et al. Bacteriologic and Clinical Efficacy of Amoxicillin/clavulanate Vs. Azithromycin in Acute Otitis Media. Pediatr Infect Dis J. 2000;19(2):95-104. PubMed PMID: 10693993.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Bacteriologic and clinical efficacy of amoxicillin/clavulanate vs. azithromycin in acute otitis media. AU - Dagan,R, AU - Johnson,C E, AU - McLinn,S, AU - Abughali,N, AU - Feris,J, AU - Leibovitz,E, AU - Burch,D J, AU - Jacobs,M R, PY - 2000/2/29/pubmed PY - 2000/3/25/medline PY - 2000/2/29/entrez SP - 95 EP - 104 JF - The Pediatric infectious disease journal JO - Pediatr. Infect. Dis. J. VL - 19 IS - 2 N2 - OBJECTIVES: To compare the bacteriologic and clinical efficacy of amoxicillin/clavulanate and azithromycin in patients with acute otitis media (AOM), particularly the ability to eradicate the predominant AOM pathogens from middle ear fluid as assessed by mandatory second tympanocentesis. METHODS: In this single blind study 238 infants and children with AOM were randomized to receive amoxicillin/clavulanate (45/6.4 mg/kg/day in two divided doses for 10 days) or azithromycin (10 mg/kg on Day 1, then 5 mg/kg daily on Days 2 through 5). Tympanocentesis was performed before the first dose and repeated on Day 4, 5 or 6. Clinical response was assessed at end of therapy between Days 12 and 14 and at follow-up between Days 22 and 28. RESULTS: Amoxicillin/clavulanate was significantly more likely to eradicate all bacterial pathogens [83% (54 of 65) vs. 49% (35 of 71), P = 0.001] and Haemophilus influenzae [87% (26 of 30) vs. 39% (13 of 33), P = 0.0001] from middle ear fluid than was azithromycin. Amoxicillin/clavulanate was also more likely to eradicate Streptococcus pneumoniae, but the difference was not statistically significant [90% (18 of 20) vs. 68% (13 of 19) [corrected], P = 0.095]. On Days 12 to 14, signs and symptoms were more likely to resolve completely or improve in all culture-positive patients [86% (60 of 70) vs. 70% (51 of 73), P = 0.023] and in those with H. influenzae infections [91% (30 of 33) vs. 65% (22 of 34), P = 0.010] who received amoxicillin/clavulanate compared with those who received azithromycin. Otherwise there were no significant differences between groups in clinical outcomes on Days 12 to 14 or at follow-up. CONCLUSIONS: Our findings indicate that amoxicillin/clavulanate has superior bacteriologic and clinical efficacy compared with azithromycin in children with AOM. SN - 0891-3668 UR - https://www.unboundmedicine.com/medline/citation/10693993/Bacteriologic_and_clinical_efficacy_of_amoxicillin/clavulanate_vs__azithromycin_in_acute_otitis_media_ L2 - http://Insights.ovid.com/pubmed?pmid=10693993 DB - PRIME DP - Unbound Medicine ER -