CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 98 enrolled
Drug / intervention
Amoxicillin-Potassium Clavulanate Combination +1 moredrug
Likely dose
Amoxicillin-Potassium Clavulanate Combination 90mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01166945
NCT01166945N/ACompleted
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Short (5 Days) Versus Long (14 Days) Duration of Antimicrobial Therapy for Acute Bacterial Sinusitis in Children

University of Wisconsin, Madison·interventional·Posted Jul 21, 2010·Updated Jun 10, 2019

In Brief

A clinical study evaluating Amoxicillin-Potassium Clavulanate Combination and Placebo for Sinusitis. Completed, enrolled 98 participants across 2 sites.

Detailed Summary

The investigators objective is to compare short course (5 days) to long course (14 days)antibiotics for the treatment of acute bacterial sinusitis in children. The investigators hypothesize that short course therapy will lead to more frequent relapses of sinusitis and will not reduce resistant organisms.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSinusitis
CountriesUnited States
CollaboratorsThrasher Research Fund

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 21, 2010
Enrollment StartNov 1, 2010
Primary CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 15.9 years ago

Interventions

Amoxicillin-Potassium Clavulanate Combinationdrug

All subjects will be started on treatment with 5 days of high dose amoxicillin (90mg/kg) with potassium clavulanate (6.4 mg/kg) twice daily in bottle A. The allocation to group B1 or B2 will be concealed until after the family and subject has signed the assent and consent, respectively. The maximum dose will be 2 gms twice daily. After 5 days the subjects will be randomized to either continue to receive the same dose of amoxicillin clavulanate or a look-a-like and taste-a-like placebo for the next 9 days.

Placebodrug

After 5 days the subjects will be randomized to either continue to receive the same dose of amoxicillin clavulanate or a look-a-like and taste-a-like placebo for the next 9 days.