Clinical trial NCT00299455: Amoxicillin Clavulanate in Treatment of Acute Otitis Media
Official title: Phase 4 Efficacy Study of Antimicrobials in the Treatment of Acute Otitis Media in Young Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Otitis Media
Lead sponsor: University of Turku
Sponsor class: OTHER
Collaborators: name: Finnish Institute for Health and Welfare
First posted: 2006-03-06
Enrollment: 320
Sex: ALL
Minimum age (years): 6
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Acute otitis media
* Age 6 - 35 mo

Exclusion Criteria:

* Spontaneous perforation of the tympanic membrane and drainage
* Systemic or nasal corticosteroid therapy within 3 preceding days
* Antihistamine therapy with 3 preceding days
* Oseltamivir therapy within 3 preceding days
* Allergy to amoxicillin/penicillin
* Tympanostomy tube present in tympanic membrane
* Clinical evidence of infection requiring systemic antimicrobial treatment
* Documented Ebstein Barr virus infection within 7 preceding days
* Down syndrome or other condition to affect middle ear infections
* Known immunodeficiency
* Vomiting or another symptom to violate per oral dosage
* Poor parental co-operation due to language or other reasons
* Use of any investigational drugs during the 4 preceding weeks

Primary outcomes:
measure: Compare time to treatment failure in children receiving amoxicillin-clavulanate to children receiving placebo
timeFrame: During the first 8 days of follow-up
Secondary outcomes:
measure: Time to resolution of symptoms in children receiving amoxicillin-clavulanate to children receiving placebo
timeFrame: Duration of study
measure: Time to resolution of acute inflammatory signs of middle ear
timeFrame: Duration of study
measure: Compare the 2 treatment groups regarding the doses of analgesic medication and number of days analgesics are administered by children's parents
timeFrame: First 7 days of follow-up
measure: Compare the 2 treatment groups regarding the number of days with absenteeism from day care and/or parental absenteeism from work
timeFrame: First 7 days of follow-up
measure: Compare the incidence of adverse events accompanying the 2 treatment regimens
timeFrame: Duration of study
measure: Time to resolution of middle ear fluid in the ear(s) that is affected on study day 1
timeFrame: Duration of study
measure: Time to relapse of acute otitis media
timeFrame: Study days 9-17
measure: Time to first reinfection of acute otitis media
timeFrame: From study day 18 to the end of follow-up
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Department of Pediatrics, Turku University Hospital
city: Turku
country: Finland
Study officials:
affiliation: Pediatrician
name: Aino Ruohola, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.