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Bacteriologic and clinical efficacy of high dose amoxicillin/clavulanate in children with acute otitis media.
Pediatr Infect Dis J 2001; 20(9):829-37PI

Abstract

OBJECTIVES

To determine the bacteriologic and clinical efficacy of high dose amoxicillin/clavulanate (90/6.4 mg/kg/day) against common bacterial pathogens causing acute otitis media (AOM), including penicillin-resistant Streptococcus pneumoniae (PRSP).

METHODS

In this open label multicenter study, 521 infants and children with AOM [mean age, 18.6 months; age < 24 months, n = 375 (72%)] were treated with amoxicillin/clavulanate 90/6.4 mg/kg/day in two divided doses for 10 days. Bilateral otitis media, previous episodes of AOM, antibiotic treatment within 3 months and day-care attendance were recorded in 60.1, 35.7, 50.2 and 38.2% of the children, respectively. Tympanocentesis was performed before the first dose and repeated on Days 4 to 6 for all children with S. pneumoniae at 22 centers and for all children with any pathogen at 3 centers. Clinical response was assessed at end of therapy.

RESULTS

Pathogens were isolated from 355 (68%) of 521 enrolled children; 180 children underwent repeat tympanocentesis and were bacteriologically evaluable. Baseline pathogens were S. pneumoniae (n = 122 enrolled/93 bacteriologically evaluable), Haemophilus influenzae (n = 160/51), both (n = 37/32) and others (n = 36/4). Pathogens were eradicated from 172 (96%) of 180 bacteriologically evaluable children. Overall 122 (98%) of 125 isolates of S. pneumoniae were eradicated, including 31 (91%) of 34 PRSP isolates (penicillin MICs 2 to 4 micrograms/ml). Seventy-eight (94%) of 83 isolates of H. influenzae were eradicated. Symptoms and otoscopic signs of acute inflammation were completely resolved or improved on Days 12 to 15 in 263 (89%) of 295 clinically evaluable children with bacteriologically documented AOM.

CONCLUSIONS

On the basis of bacteriologic outcome on Days 4 to 6 and clinical outcome on Days 12 to 15, we found that high dose amoxicillin/clavulanate (90/6.4 mg/kg/day) was highly efficacious in children with AOM, including those most likely to fail treatment, namely children < 24 months of age and those with infectious caused by PRSP.

Authors+Show Affiliations

Soroka University Medical Center, 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
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

11734759

Citation

Dagan, R, et al. "Bacteriologic and Clinical Efficacy of High Dose Amoxicillin/clavulanate in Children With Acute Otitis Media." The Pediatric Infectious Disease Journal, vol. 20, no. 9, 2001, pp. 829-37.
Dagan R, Hoberman A, Johnson C, et al. Bacteriologic and clinical efficacy of high dose amoxicillin/clavulanate in children with acute otitis media. Pediatr Infect Dis J. 2001;20(9):829-37.
Dagan, R., Hoberman, A., Johnson, C., Leibovitz, E. L., Arguedas, A., Rose, F. V., ... Jacobs, M. R. (2001). Bacteriologic and clinical efficacy of high dose amoxicillin/clavulanate in children with acute otitis media. The Pediatric Infectious Disease Journal, 20(9), pp. 829-37.
Dagan R, et al. Bacteriologic and Clinical Efficacy of High Dose Amoxicillin/clavulanate in Children With Acute Otitis Media. Pediatr Infect Dis J. 2001;20(9):829-37. PubMed PMID: 11734759.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Bacteriologic and clinical efficacy of high dose amoxicillin/clavulanate in children with acute otitis media. AU - Dagan,R, AU - Hoberman,A, AU - Johnson,C, AU - Leibovitz,E L, AU - Arguedas,A, AU - Rose,F V, AU - Wynne,B R, AU - Jacobs,M R, PY - 2001/12/6/pubmed PY - 2002/1/10/medline PY - 2001/12/6/entrez SP - 829 EP - 37 JF - The Pediatric infectious disease journal JO - Pediatr. Infect. Dis. J. VL - 20 IS - 9 N2 - OBJECTIVES: To determine the bacteriologic and clinical efficacy of high dose amoxicillin/clavulanate (90/6.4 mg/kg/day) against common bacterial pathogens causing acute otitis media (AOM), including penicillin-resistant Streptococcus pneumoniae (PRSP). METHODS: In this open label multicenter study, 521 infants and children with AOM [mean age, 18.6 months; age < 24 months, n = 375 (72%)] were treated with amoxicillin/clavulanate 90/6.4 mg/kg/day in two divided doses for 10 days. Bilateral otitis media, previous episodes of AOM, antibiotic treatment within 3 months and day-care attendance were recorded in 60.1, 35.7, 50.2 and 38.2% of the children, respectively. Tympanocentesis was performed before the first dose and repeated on Days 4 to 6 for all children with S. pneumoniae at 22 centers and for all children with any pathogen at 3 centers. Clinical response was assessed at end of therapy. RESULTS: Pathogens were isolated from 355 (68%) of 521 enrolled children; 180 children underwent repeat tympanocentesis and were bacteriologically evaluable. Baseline pathogens were S. pneumoniae (n = 122 enrolled/93 bacteriologically evaluable), Haemophilus influenzae (n = 160/51), both (n = 37/32) and others (n = 36/4). Pathogens were eradicated from 172 (96%) of 180 bacteriologically evaluable children. Overall 122 (98%) of 125 isolates of S. pneumoniae were eradicated, including 31 (91%) of 34 PRSP isolates (penicillin MICs 2 to 4 micrograms/ml). Seventy-eight (94%) of 83 isolates of H. influenzae were eradicated. Symptoms and otoscopic signs of acute inflammation were completely resolved or improved on Days 12 to 15 in 263 (89%) of 295 clinically evaluable children with bacteriologically documented AOM. CONCLUSIONS: On the basis of bacteriologic outcome on Days 4 to 6 and clinical outcome on Days 12 to 15, we found that high dose amoxicillin/clavulanate (90/6.4 mg/kg/day) was highly efficacious in children with AOM, including those most likely to fail treatment, namely children < 24 months of age and those with infectious caused by PRSP. SN - 0891-3668 UR - https://www.unboundmedicine.com/medline/citation/11734759/Bacteriologic_and_clinical_efficacy_of_high_dose_amoxicillin/clavulanate_in_children_with_acute_otitis_media_ L2 - http://Insights.ovid.com/pubmed?pmid=11734759 DB - PRIME DP - Unbound Medicine ER -