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

NCT02340000 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 315

Last updated 2017-08-24

Study results available
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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.

Conditions

  • Sinusitis

Interventions

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

Sponsors & Collaborators

  • Albany Medical College

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-18
Primary Completion
2017-02-27
Completion
2017-02-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02340000 on ClinicalTrials.gov