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Amoxicillin Clavulanate in Treatment of Acute Otitis Media

NCT00299455 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2009-02-11

No results posted yet for this study

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.

Conditions

  • Acute Otitis Media

Interventions

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.

Sponsors & Collaborators

  • Finnish Institute for Health and Welfare

    collaborator OTHER_GOV

  • University of Turku

    lead OTHER

Principal Investigators

  • Aino Ruohola, MD, PhD · Pediatrician

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
35 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2008-12-31
Completion
2009-03-31

Countries

  • Finland

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00299455 on ClinicalTrials.gov