Official Title: “Phase 4 Efficacy Study of Antimicrobials in the Treatment of Acute Otitis Media in Young Children”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study

Study Primary Completion Date: December 2008

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Reconstituted amoxicillin-clavulanate at 40/5.7 mg/kg/day in 2 divided doses for 7 days.
• Placebo Comparator: 2
  • Reconstituted placebo in 2 divided doses for 7 days.

Primary 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
    Safety Issue?: No

Secondary Measures

• Time to resolution of symptoms in children receiving amoxicillin-clavulanate to children receiving placebo
  • Time Frame: Duration of study
    Safety Issue?: No
• Time to resolution of acute inflammatory signs of middle ear
  • Time Frame: Duration of study
    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
    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
    Safety Issue?: No
• Compare the incidence of adverse events accompanying the 2 treatment regimens
  • Time Frame: Duration of study
    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
    Safety Issue?: No
• Time to relapse of acute otitis media
  • Time Frame: Study days 9-17
    Safety Issue?: No
• Time to first reinfection of acute otitis media
  • Time Frame: From study day 18 to the end of follow-up
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Months

Maximum Age for this Clinical Trial: 35 Months

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Turku

Overall Clinical Trial Officials and Contacts

Aino Ruohola, MD, PhD Principal Investigator Pediatrician  

Overall Contact: Aino Ruohola, MD, PhD +358 - 40 - 738 7358 aino.ruohola@utu.fi

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00299455

Study ID Number: RRR-60

ClinicalTrials.gov Identifier: NCT00299455

Health Authority: Finland: National Agency for Medicines