Amoxicillin Clavulanate in Treatment of Acute Otitis Media - Full Text View

Sponsor:	University of Turku
Collaborator:	National Institute for Health and Welfare, Finland
Information provided by:	University of Turku
ClinicalTrials.gov Identifier:	NCT00299455

Purpose

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.

Condition	Intervention	Phase
Acute Otitis Media	Drug: amoxicillin-clavulanate Drug: Placebo	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Phase 4 Efficacy Study of Antimicrobials in the Treatment of Acute Otitis Media in Young Children

Resource links provided by NLM:

MedlinePlus related topics: Ear Infections

Drug Information available for: Amoxicillin sodium Amoxicillin

U.S. FDA Resources

Further study details as provided by University of Turku:

Primary Outcome Measures:

Compare time to treatment failure in children receiving amoxicillin-clavulanate to children receiving placebo [ Time Frame: During the first 8 days of follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to resolution of symptoms in children receiving amoxicillin-clavulanate to children receiving placebo [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
Time to resolution of acute inflammatory signs of middle ear [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Compare the incidence of adverse events accompanying the 2 treatment regimens [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
Time to resolution of middle ear fluid in the ear(s) that is affected on study day 1 [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
Time to relapse of acute otitis media [ Time Frame: Study days 9-17 ] [ Designated as safety issue: No ]
Time to first reinfection of acute otitis media [ Time Frame: From study day 18 to the end of follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment:	320
Study Start Date:	March 2006
Estimated Study Completion Date:	March 2009
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Reconstituted amoxicillin-clavulanate at 40/5.7 mg/kg/day in 2 divided doses for 7 days.	Drug: amoxicillin-clavulanate 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.
Placebo Comparator: 2 Reconstituted placebo in 2 divided doses for 7 days.	Drug: Placebo Placebo twice a day for 7 days. Placebo capsules contain lactose monohydrate 640 mg.

Arms

Assigned Interventions

Experimental: 1

Reconstituted amoxicillin-clavulanate at 40/5.7 mg/kg/day in 2 divided doses for 7 days.

Drug: amoxicillin-clavulanate

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.

Placebo Comparator: 2

Reconstituted placebo in 2 divided doses for 7 days.

Drug: Placebo

Placebo twice a day for 7 days. Placebo capsules contain lactose monohydrate 640 mg.

Eligibility

Ages Eligible for Study:	6 Months to 35 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00299455

Locations

Finland
Department of Pediatrics, Turku University Hospital
Turku, Finland, 20521

Turku, Finland

Sponsors and Collaborators

University of Turku

National Institute for Health and Welfare, Finland

Investigators

Principal Investigator:

Aino Ruohola, MD, PhD

Pediatrician

More Information

No publications provided by University of Turku

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Tähtinen 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.

McGill HC Jr, McMahan CA, Zieske AW, Tracy RE, Malcom GT, Herderick EE, Strong JP. Association of Coronary Heart Disease Risk Factors with microscopic qualities of coronary atherosclerosis in youth. Circulation. 2000 Jul 25;102(4):374-9.

Responsible Party:	Aino Ruohola, Department of Pediatrcis, Turku University Hospital, Turku, Finland
ClinicalTrials.gov Identifier:	NCT00299455 History of Changes
Other Study ID Numbers:	RRR-60
Study First Received:	March 3, 2006
Last Updated:	February 10, 2009
Health Authority:	Finland: Finnish Medicines Agency

Additional relevant MeSH terms:

Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
Amoxicillin
Amoxicillin-Potassium Clavulanate Combination
Clavulanic Acids

Clavulanic Acid
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 24, 2012