Amoxicillin Clavulanate in Treatment of Acute Otitis Media
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|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Acute Otitis Media||Drug: amoxicillin-clavulanate Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||320 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Phase 4 Efficacy Study of Antimicrobials in the Treatment of Acute Otitis Media in Young Children|
|Study Start Date :||March 2006|
|Primary Completion Date :||December 2008|
|Estimated Study Completion Date :||March 2009|
Reconstituted amoxicillin-clavulanate at 40/5.7 mg/kg/day in 2 divided doses for 7 days.
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.
Placebo twice a day for 7 days. Placebo capsules contain lactose monohydrate 640 mg.
- Compare time to treatment failure in children receiving amoxicillin-clavulanate to children receiving placebo [ Time Frame: During the first 8 days of follow-up ]
- Time to resolution of symptoms in children receiving amoxicillin-clavulanate to children receiving placebo [ Time Frame: Duration of study ]
- Time to resolution of acute inflammatory signs of middle ear [ Time Frame: Duration of study ]
- 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 ]
- 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 ]
- Compare the incidence of adverse events accompanying the 2 treatment regimens [ Time Frame: Duration of study ]
- Time to resolution of middle ear fluid in the ear(s) that is affected on study day 1 [ Time Frame: Duration of study ]
- Time to relapse of acute otitis media [ Time Frame: Study days 9-17 ]
- Time to first reinfection of acute otitis media [ Time Frame: From study day 18 to the end of follow-up ]
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 ClinicalTrials.gov identifier (NCT number): NCT00299455
|Department of Pediatrics, Turku University Hospital|
|Turku, Finland, 20521|
|Principal Investigator:||Aino Ruohola, MD, PhD||Pediatrician|