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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

315 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-18

Study Completion Date

2017-02-27

Brief Summary

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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.

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Detailed Description

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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

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Sinusitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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standard dose

amoxicillin/clavulanate 875/125 mg + placebo tablet twice a day for 7 days

Group Type ACTIVE_COMPARATOR

standard dose amoxicillin/clavulanate

Intervention Type DRUG

amoxicillin/clavulanate 875/125 + placebo bid x 7 days

high dose

Time Period I (November 18, 2014-January 5, 2016): extended-release amoxicillin/clavulanate 1000/62.5 mg 2 tablets (by different manufacturer) twice a day for 7 days Time Period 2 (February 6, 2016-February 27, 2017): immediate-release amoxicillin/clavunate 875/125 mg plus standard immediate-release amoxicillin 875 mg twice a day for 7 days

Group Type EXPERIMENTAL

high dose amoxicillin/clavulanate

Intervention Type DRUG

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

Interventions

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standard dose amoxicillin/clavulanate

amoxicillin/clavulanate 875/125 + placebo bid x 7 days

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Adult 18 or over
2. Meets definition of acute sinusitis by Infectious Disease Society of America (2012)
3. Clinician and participant chose to start antibiotic treatment

Exclusion Criteria

1. Previously enrolled in the study
2. Allergic or intolerant to amoxicillin, penicillin, or amoxicillin/clavulanate
3. Specific medication concerns: lactating (since safety of clavulanate unknown); taking allopurinol (increased risk of rash); concurrent mononucleosis (increased risk of rash with amoxicillin); chronic kidney disease with glomerular filtration rate \< 30; significant hepatic impairment; history of antibiotic-associated colitis
4. Cognitive impairment so that unable to give informed consent or give reliable assessment of improvement
5. Need to use high-dose amoxicillin/clavulanate: treatment with amoxicllin or penicillin within the past month (risk of penicillin-resistant pneumococci), very ill patient (though not ill enough to send to hospital); immunocompromise
6. Need to hospitalize the patient

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes