Amoxicillin Clavulanate in Treatment of Acute Otitis Media

Condition(s) targeted: Acute Otitis Media

Intervention: amoxicillin-clavulanate (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of Turku

Official(s) and/or principal investigator(s):
Aino Ruohola, MD, PhD, Principal Investigator, Affiliation: Pediatrician

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

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.

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

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

Primary outcome: Compare time to treatment failure in children receiving amoxicillin-clavulanate to children receiving placebo

Secondary outcome:

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

Minimum age: 6 Months. Maximum age: 35 Months. Gender(s): Both.

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

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

Department of Pediatrics, Turku University Hospital, Turku 20521, Finland; Recruiting
Aino Ruohola, MD, PhD, Principal Investigator

Starting date: March 2006
Ending date: December 2009
Last updated: August 26, 2008