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Sponsors and Collaborators: |
University of Turku National Institute for Health and Welfare, Finland |
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Information provided by: | University of Turku |
ClinicalTrials.gov Identifier: | NCT00299455 |
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 |
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Acute Otitis Media |
Drug: amoxicillin-clavulanate Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Phase 4 Efficacy Study of Antimicrobials in the Treatment of Acute Otitis Media in Young Children |
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 |
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1: Experimental
Reconstituted amoxicillin-clavulanate at 40/5.7 mg/kg/day in 2 divided doses for 7 days.
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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.
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2: Placebo Comparator
Reconstituted placebo in 2 divided doses for 7 days.
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Drug: Placebo
Placebo twice a day for 7 days. Placebo capsules contain lactose monohydrate 640 mg.
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Ages Eligible for Study: | 6 Months to 35 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Finland | |
Department of Pediatrics, Turku University Hospital | |
Turku, Finland, 20521 | |
Turku, Finland |
Principal Investigator: | Aino Ruohola, MD, PhD | Pediatrician |
Responsible Party: | Department of Pediatrcis, Turku University Hospital, Turku, Finland ( Aino Ruohola ) |
Study ID Numbers: | RRR-60 |
Study First Received: | March 3, 2006 |
Last Updated: | February 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00299455 History of Changes |
Health Authority: | Finland: National Agency for Medicines |
Anti-Bacterial Agents Amoxicillin Otorhinolaryngologic Diseases Clavulanic Acid Otitis |
Otitis Media Clavulanic Acids Amoxicillin-Potassium Clavulanate Combination Ear Diseases |
Anti-Infective Agents Amoxicillin Otorhinolaryngologic Diseases Molecular Mechanisms of Pharmacological Action Otitis Media Clavulanic Acids Enzyme Inhibitors |
Amoxicillin-Potassium Clavulanate Combination Ear Diseases Pharmacologic Actions Anti-Bacterial Agents Otitis Clavulanic Acid Therapeutic Uses |