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Treatment of Acute Sinusitis With High-Dose vs. Standard-Dose Amoxicillin/Clavulanate

NCT03431337 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 157

Last updated 2021-08-12

Study results available
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Summary

Comparative-effectiveness study of the treatment of acute bacterial sinusitis with amoxicillin/clavulanate 875mg/125mg bid for 7 days with or without the addition of immediate-release amoxicillin 875 mg bid x 7 days. .

Conditions

  • Sinusitis, Acute

Interventions

DRUG

Amoxicillin 875 mg

Doubling the dose of amoxicillin by adding amoxicillin 875 to each dose of the standard treatment of amoxicillin/clavulanate 875/125

DIETARY_SUPPLEMENT

Placebo (lactase)

Placebo (in place of additional amoxicillin in experimental arm)

Sponsors & Collaborators

  • Paul Sorum, MD

    lead OTHER

Principal Investigators

  • Paul C Sorum, MD, PhD · Albany Medical College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-26
Primary Completion
2020-05-31
Completion
2020-05-31
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 NCT03431337 on ClinicalTrials.gov