Back to resultsAmoxicillin Clavulanate in Treatment of Acute Otitis Media
Primary Purpose
Acute Otitis Media
Status
Unknown status
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
amoxicillin-clavulanate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute Otitis Media
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
Sites / Locations
- Department of Pediatrics, Turku University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Reconstituted amoxicillin-clavulanate at 40/5.7 mg/kg/day in 2 divided doses for 7 days.
Reconstituted placebo in 2 divided doses for 7 days.
Outcomes
Primary Outcome Measures
Compare time to treatment failure in children receiving amoxicillin-clavulanate to children receiving placebo
Secondary Outcome Measures
Time to resolution of symptoms in children receiving amoxicillin-clavulanate to children receiving placebo
Time to resolution of acute inflammatory signs of middle ear
Compare the 2 treatment groups regarding the doses of analgesic medication and number of days analgesics are administered by children's parents
Compare the 2 treatment groups regarding the number of days with absenteeism from day care and/or parental absenteeism from work
Compare the incidence of adverse events accompanying the 2 treatment regimens
Time to resolution of middle ear fluid in the ear(s) that is affected on study day 1
Time to relapse of acute otitis media
Time to first reinfection of acute otitis media
Full Information
NCT ID
NCT00299455
First Posted
March 3, 2006
Last Updated
February 10, 2009
Sponsor
University of Turku
Collaborators
Finnish Institute for Health and Welfare
1. Study Identification
Unique Protocol Identification Number
NCT00299455
Brief Title
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
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Unknown status
Study Start Date
March 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
March 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Turku
Collaborators
Finnish Institute for Health and Welfare
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Otitis Media
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
320 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Reconstituted amoxicillin-clavulanate at 40/5.7 mg/kg/day in 2 divided doses for 7 days.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Reconstituted placebo in 2 divided doses for 7 days.
Intervention Type
Drug
Intervention Name(s)
amoxicillin-clavulanate
Intervention Description
Amoxicillin clavulanate 40 mg/kg/day divided into two daily doses for 7 days. Capsules will be produced by pulverizing amoxicillin clavulanate tablets (Augmentin 875 mg; manufacturer Glaxo SmithKline Beecham; ATC Code: J01CR02) and mixing that with lactose monohydrate. Each capsule will contain Augmentin tablet powder 68 mg and lactose monohydrate 572 mg. This means amoxicillin 40 mg and clavulanate 5,7 mg respecting the dose per 2 kg.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo twice a day for 7 days. Placebo capsules contain lactose monohydrate 640 mg.
Primary Outcome Measure Information:
Title
Compare time to treatment failure in children receiving amoxicillin-clavulanate to children receiving placebo
Time Frame
During the first 8 days of follow-up
Secondary Outcome Measure Information:
Title
Time to resolution of symptoms in children receiving amoxicillin-clavulanate to children receiving placebo
Time Frame
Duration of study
Title
Time to resolution of acute inflammatory signs of middle ear
Time Frame
Duration of study
Title
Compare the 2 treatment groups regarding the doses of analgesic medication and number of days analgesics are administered by children's parents
Time Frame
First 7 days of follow-up
Title
Compare the 2 treatment groups regarding the number of days with absenteeism from day care and/or parental absenteeism from work
Time Frame
First 7 days of follow-up
Title
Compare the incidence of adverse events accompanying the 2 treatment regimens
Time Frame
Duration of study
Title
Time to resolution of middle ear fluid in the ear(s) that is affected on study day 1
Time Frame
Duration of study
Title
Time to relapse of acute otitis media
Time Frame
Study days 9-17
Title
Time to first reinfection of acute otitis media
Time Frame
From study day 18 to the end of follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
35 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aino Ruohola, MD, PhD
Organizational Affiliation
Pediatrician
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pediatrics, Turku University Hospital
City
Turku
ZIP/Postal Code
20521
Country
Finland
City
Turku
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
30572868
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.
Results Reference
derived
PubMed Identifier
28340091
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.
Results Reference
derived
PubMed Identifier
26651157
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.
Results Reference
derived
PubMed Identifier
26183005
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.
Results Reference
derived
PubMed Identifier
21226577
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.
Results Reference
derived
PubMed Identifier
20368317
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.
Results Reference
derived
Learn more about this trial
Amoxicillin Clavulanate in Treatment of Acute Otitis Media
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