Tags

Type your tag names separated by a space and hit enter

A placebo-controlled trial of antimicrobial treatment for acute otitis media.
N Engl J Med 2011; 364(2):116-26NEJM

Abstract

BACKGROUND

The efficacy of antimicrobial treatment in children with acute otitis media remains controversial.

METHODS

In this randomized, double-blind trial, children 6 to 35 months of age with acute otitis media, diagnosed with the use of strict criteria, received amoxicillin-clavulanate (161 children) or placebo (158 children) for 7 days. The primary outcome was the time to treatment failure from the first dose until the end-of-treatment visit on day 8. The definition of treatment failure was based on the overall condition of the child (including adverse events) and otoscopic signs of acute otitis media.

RESULTS

Treatment failure occurred in 18.6% of the children who received amoxicillin-clavulanate, as compared with 44.9% of the children who received placebo (P<0.001). The difference between the groups was already apparent at the first scheduled visit (day 3), at which time 13.7% of the children who received amoxicillin-clavulanate, as compared with 25.3% of those who received placebo, had treatment failure. Overall, amoxicillin-clavulanate reduced the progression to treatment failure by 62% (hazard ratio, 0.38; 95% confidence interval [CI], 0.25 to 0.59; P<0.001) and the need for rescue treatment by 81% (6.8% vs. 33.5%; hazard ratio, 0.19; 95% CI, 0.10 to 0.36; P<0.001). Analgesic or antipyretic agents were given to 84.2% and 85.9% of the children in the amoxicillin-clavulanate and placebo groups, respectively. Adverse events were significantly more common in the amoxicillin-clavulanate group than in the placebo group. A total of 47.8% of the children in the amoxicillin-clavulanate group had diarrhea, as compared with 26.6% in the placebo group (P<0.001); 8.7% and 3.2% of the children in the respective groups had eczema (P=0.04).

CONCLUSIONS

Children with acute otitis media benefit from antimicrobial treatment as compared with placebo, although they have more side effects. Future studies should identify patients who may derive the greatest benefit, in order to minimize unnecessary antimicrobial treatment and the development of bacterial resistance. (Funded by the Foundation for Paediatric Research and others; ClinicalTrials.gov number, NCT00299455.).

Authors+Show Affiliations

Department of Pediatrics, Turku University Hospital, Turku, Finland.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

21226577

Citation

Tähtinen, Paula A., et al. "A Placebo-controlled Trial of Antimicrobial Treatment for Acute Otitis Media." The New England Journal of Medicine, vol. 364, no. 2, 2011, pp. 116-26.
Tähtinen PA, Laine MK, Huovinen P, et al. A placebo-controlled trial of antimicrobial treatment for acute otitis media. N Engl J Med. 2011;364(2):116-26.
Tähtinen, P. A., Laine, M. K., Huovinen, P., Jalava, J., Ruuskanen, O., & Ruohola, A. (2011). A placebo-controlled trial of antimicrobial treatment for acute otitis media. The New England Journal of Medicine, 364(2), pp. 116-26. doi:10.1056/NEJMoa1007174.
Tähtinen PA, et al. A Placebo-controlled Trial of Antimicrobial Treatment for Acute Otitis Media. N Engl J Med. 2011 Jan 13;364(2):116-26. PubMed PMID: 21226577.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A placebo-controlled trial of antimicrobial treatment for acute otitis media. AU - Tähtinen,Paula A, AU - Laine,Miia K, AU - Huovinen,Pentti, AU - Jalava,Jari, AU - Ruuskanen,Olli, AU - Ruohola,Aino, PY - 2011/1/14/entrez PY - 2011/1/14/pubmed PY - 2011/1/21/medline SP - 116 EP - 26 JF - The New England journal of medicine JO - N. Engl. J. Med. VL - 364 IS - 2 N2 - BACKGROUND: The efficacy of antimicrobial treatment in children with acute otitis media remains controversial. METHODS: In this randomized, double-blind trial, children 6 to 35 months of age with acute otitis media, diagnosed with the use of strict criteria, received amoxicillin-clavulanate (161 children) or placebo (158 children) for 7 days. The primary outcome was the time to treatment failure from the first dose until the end-of-treatment visit on day 8. The definition of treatment failure was based on the overall condition of the child (including adverse events) and otoscopic signs of acute otitis media. RESULTS: Treatment failure occurred in 18.6% of the children who received amoxicillin-clavulanate, as compared with 44.9% of the children who received placebo (P<0.001). The difference between the groups was already apparent at the first scheduled visit (day 3), at which time 13.7% of the children who received amoxicillin-clavulanate, as compared with 25.3% of those who received placebo, had treatment failure. Overall, amoxicillin-clavulanate reduced the progression to treatment failure by 62% (hazard ratio, 0.38; 95% confidence interval [CI], 0.25 to 0.59; P<0.001) and the need for rescue treatment by 81% (6.8% vs. 33.5%; hazard ratio, 0.19; 95% CI, 0.10 to 0.36; P<0.001). Analgesic or antipyretic agents were given to 84.2% and 85.9% of the children in the amoxicillin-clavulanate and placebo groups, respectively. Adverse events were significantly more common in the amoxicillin-clavulanate group than in the placebo group. A total of 47.8% of the children in the amoxicillin-clavulanate group had diarrhea, as compared with 26.6% in the placebo group (P<0.001); 8.7% and 3.2% of the children in the respective groups had eczema (P=0.04). CONCLUSIONS: Children with acute otitis media benefit from antimicrobial treatment as compared with placebo, although they have more side effects. Future studies should identify patients who may derive the greatest benefit, in order to minimize unnecessary antimicrobial treatment and the development of bacterial resistance. (Funded by the Foundation for Paediatric Research and others; ClinicalTrials.gov number, NCT00299455.). SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/21226577/A_placebo_controlled_trial_of_antimicrobial_treatment_for_acute_otitis_media_ L2 - http://www.nejm.org/doi/full/10.1056/NEJMoa1007174?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -