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Amoxicillin Clavulanate in Treatment of Acute Otitis Media

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00299455
Recruitment Status : Unknown
Verified February 2009 by University of Turku.
Recruitment status was:  Active, not recruiting
First Posted : March 6, 2006
Last Update Posted : February 11, 2009
National Institute for Health and Welfare, Finland
Information provided by:
University of Turku

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.

Condition or disease Intervention/treatment Phase
Acute Otitis Media Drug: amoxicillin-clavulanate Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 4 Efficacy Study of Antimicrobials in the Treatment of Acute Otitis Media in Young Children
Study Start Date : March 2006
Actual Primary Completion Date : December 2008
Estimated Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 Measures :
  1. Time to resolution of symptoms in children receiving amoxicillin-clavulanate to children receiving placebo [ Time Frame: Duration of study ]
  2. Time to resolution of acute inflammatory signs of middle ear [ Time Frame: Duration of study ]
  3. 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 ]
  4. 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 ]
  5. Compare the incidence of adverse events accompanying the 2 treatment regimens [ Time Frame: Duration of study ]
  6. Time to resolution of middle ear fluid in the ear(s) that is affected on study day 1 [ Time Frame: Duration of study ]
  7. Time to relapse of acute otitis media [ Time Frame: Study days 9-17 ]
  8. Time to first reinfection of acute otitis media [ Time Frame: From study day 18 to the end of follow-up ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 35 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00299455

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Department of Pediatrics, Turku University Hospital
Turku, Finland, 20521
Turku, Finland
Sponsors and Collaborators
University of Turku
National Institute for Health and Welfare, Finland
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Principal Investigator: Aino Ruohola, MD, PhD Pediatrician

Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Aino Ruohola, Department of Pediatrcis, Turku University Hospital, Turku, Finland Identifier: NCT00299455    
Other Study ID Numbers: RRR-60
First Posted: March 6, 2006    Key Record Dates
Last Update Posted: February 11, 2009
Last Verified: February 2009
Additional relevant MeSH terms:
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Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
Clavulanic Acid
Clavulanic Acids
Amoxicillin-Potassium Clavulanate Combination
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action