NCT02340000

Clinical Trial of the Treatment of Acute Sinusitis With Standard-dose Versus High-dose Amoxicillin/Clavulanate

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 315 (actual)
• Sponsor: Albany Medical College · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

The aim was amended in February 2016--because of the unexpected unavailability of the original high-dose formulation of amoxicillin/clavulanate--to compare the effectiveness (versus standard dose) of extended-release (the original formulation) versus immediate-release amoxicillin/clavulanate.

Conditions

• Sinusitis

Interventions

Type	Name	Description
DRUG	standard dose amoxicillin/clavulanate	amoxicillin/clavulanate 875/125 + placebo bid x 7 days
DRUG	high dose amoxicillin/clavulanate	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

Timeline

• Start date: 2014-11-18
• Primary completion: 2017-02-27
• Completion: 2017-02-27
• First posted: 2015-01-16
• Last updated: 2017-08-24
• Results posted: 2017-08-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study