At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 315 enrolled
Drug / intervention
standard dose amoxicillin/clavulanate +1 moredrug
Likely dose
Not stated in 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.
Clinical Trial of the Treatment of Acute Sinusitis With Standard-dose Versus High-dose Amoxicillin/Clavulanate
In Brief
A Phase 4 clinical trial evaluating standard dose amoxicillin/clavulanate and high dose amoxicillin/clavulanate for Sinusitis. Completed, enrolled 315 participants across 1 site.
Detailed Summary
The aim is to determine if high-dose amoxicillin/clavulanate is more effective than standard-dose amoxicillin/clavulanate in treating acute bacterial sinusitis in adults seen at a primary care office.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSinusitis
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartNov 2014
First PostedJan 2015
Primary CompletionFeb 2017
TodayJul 2026
First PostedJan 16, 2015
Enrollment StartNov 18, 2014
Primary CompletionFeb 27, 2017
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 11.5 years ago
Interventions
standard dose amoxicillin/clavulanatedrug
amoxicillin/clavulanate 875/125 + placebo bid x 7 days
high dose amoxicillin/clavulanatedrug
Time Period I: extended-release amoxicillin/clavulanate 1000/62.5 two tablets bid x 7 days Time Period 2: immediate-release amoxicillin/clavulanate 875/125 plus amoxicllin 875 bid x 7 days