Amoxicillin Clavulanate in Treatment of Acute Otitis Media

Summary

This is a prospective, randomized, double-blind, placebo controlled one-center study carried out in primary care setting of the health center of City of Turku, Finland. The study patients will be allocated to one of the two parallel treatment groups (amoxicillin-clavulanate or placebo). The hypothesis is that the symptoms and signs of acute otitis media are resolved more effectively with antimicrobial treatment than with placebo. Furthermore, this study aims at finding out prognostic factors that could help to direct antimicrobial treatment for correct subgroups of young patients.

Timeline

Start

2006-03

Primary completion

2008-12

Completion

2009-03

Outcome

Met primary endpoint

paper 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). PMID 21226577 ↗

Publications

• Uitti JM, Salantera S, Laine MK, Tahtinen PA, Ruohola A. Adaptation of pain scales for parent observation: are pain scales and symptoms useful in detecting pain of young children with the suspicion of acute otitis media? BMC Pediatr. 2018 Dec 20;18(1):392. doi: 10.1186/s12887-018-1361-y.
• Ruohola A, Laine MK, Tahtinen PA. Effect of Antimicrobial Treatment on the Resolution of Middle-Ear Effusion After Acute Otitis Media. J Pediatric Infect Dis Soc. 2018 Feb 19;7(1):64-70. doi: 10.1093/jpids/pix008.
• Laine MK, Tahtinen PA, Ruuskanen O, Loyttyniemi E, Ruohola A. Can trained nurses exclude acute otitis media with tympanometry or acoustic reflectometry in symptomatic children? Scand J Prim Health Care. 2015;33(4):298-304. doi: 10.3109/02813432.2015.1118835. Epub 2015 Dec 14.
• Erkkola-Anttinen N, Laine MK, Tahtinen PA, Ruohola A. Parental role in the diagnostics of otitis media: can layman parents use spectral gradient acoustic reflectometry reliably? Int J Pediatr Otorhinolaryngol. 2015 Sep;79(9):1516-21. doi: 10.1016/j.ijporl.2015.06.040. Epub 2015 Jul 6.
• Tahtinen PA, Laine MK, Huovinen P, Jalava J, Ruuskanen O, Ruohola A. A placebo-controlled trial of antimicrobial treatment for acute otitis media. N Engl J Med. 2011 Jan 13;364(2):116-26. doi: 10.1056/NEJMoa1007174.
• Laine MK, Tahtinen PA, Ruuskanen O, Huovinen P, Ruohola A. Symptoms or symptom-based scores cannot predict acute otitis media at otitis-prone age. Pediatrics. 2010 May;125(5):e1154-61. doi: 10.1542/peds.2009-2689. Epub 2010 Apr 5.

Drugs

Indications