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

Primary Purpose

Sinusitis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
standard dose amoxicillin/clavulanate
high dose amoxicillin/clavulanate
Sponsored by
Albany Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sinusitis focused on measuring acute sinusitis, amoxicillin/clavulanate, adults, outcomes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Albany Medical Center Internal Medicine and Pediatrics

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

standard dose

high dose

Arm Description

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

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

Outcomes

Primary Outcome Measures

Subjective Improvement - Day 3 (Rating of "a Lot Better" or "no Symptoms")
rating of "a lot better" or "no symptoms"

Secondary Outcome Measures

SNOT-16 - Day 3
Ratings on a scale from 0=none to 3=severe of 16 sinusitis-related symptoms. Total score can range from 0 to 48 (with 48 the most severe possible) of the 16 symptoms. The outcome measure was the mean difference in the ratings of each of the 16 symptoms between day 0 and day 3 (values at day 0 minus values at day 3).
Subjective Improvement - Day 10
rating of "a lot better" or "no symptoms"
SNOT-16 - Day 10
Ratings on a scale from 0=none to 3=severe of 16 sinusitis-related symptoms. Total score can range from 0 to 48 (with 48 the most severe possible) of the 16 symptoms. The outcome measure was the mean difference in the ratings of each of the 16 symptoms between day 0 and day 10 (values at day 0 minus values at day 10).
Nasal Colonization With Resistant Bacteria
Clinicians performed anterior nasal cultures to look for colonization with penicillin-resistant pneumococci and other pathogens (stopped after participant #231 because of lack of funds).
Willingness to Take the Study Antibiotic in the Future
whether participants said they would NOT take the antibiotic again

Full Information

First Posted
November 22, 2014
Last Updated
August 22, 2017
Sponsor
Albany Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT02340000
Brief Title
Clinical Trial of the Treatment of Acute Sinusitis With Standard-dose Versus High-dose Amoxicillin/Clavulanate
Official Title
Clinical Trial of the Treatment of Acute Sinusitis With Standard-dose Versus High-dose Amoxicillin/Clavulanate
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
November 18, 2014 (Actual)
Primary Completion Date
February 27, 2017 (Actual)
Study Completion Date
February 27, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albany Medical College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sinusitis
Keywords
acute sinusitis, amoxicillin/clavulanate, adults, outcomes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
315 (Actual)

8. Arms, Groups, and Interventions

Arm Title
standard dose
Arm Type
Active Comparator
Arm Description
amoxicillin/clavulanate 875/125 mg + placebo tablet twice a day for 7 days
Arm Title
high dose
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
standard dose amoxicillin/clavulanate
Intervention Description
amoxicillin/clavulanate 875/125 + placebo bid x 7 days
Intervention Type
Drug
Intervention Name(s)
high dose amoxicillin/clavulanate
Intervention Description
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
Primary Outcome Measure Information:
Title
Subjective Improvement - Day 3 (Rating of "a Lot Better" or "no Symptoms")
Description
rating of "a lot better" or "no symptoms"
Time Frame
end of 3 days of treatment
Secondary Outcome Measure Information:
Title
SNOT-16 - Day 3
Description
Ratings on a scale from 0=none to 3=severe of 16 sinusitis-related symptoms. Total score can range from 0 to 48 (with 48 the most severe possible) of the 16 symptoms. The outcome measure was the mean difference in the ratings of each of the 16 symptoms between day 0 and day 3 (values at day 0 minus values at day 3).
Time Frame
day 0, end of 3 days of treatment
Title
Subjective Improvement - Day 10
Description
rating of "a lot better" or "no symptoms"
Time Frame
end of 10th day
Title
SNOT-16 - Day 10
Description
Ratings on a scale from 0=none to 3=severe of 16 sinusitis-related symptoms. Total score can range from 0 to 48 (with 48 the most severe possible) of the 16 symptoms. The outcome measure was the mean difference in the ratings of each of the 16 symptoms between day 0 and day 10 (values at day 0 minus values at day 10).
Time Frame
day 0, end of 10th day
Title
Nasal Colonization With Resistant Bacteria
Description
Clinicians performed anterior nasal cultures to look for colonization with penicillin-resistant pneumococci and other pathogens (stopped after participant #231 because of lack of funds).
Time Frame
baseline
Title
Willingness to Take the Study Antibiotic in the Future
Description
whether participants said they would NOT take the antibiotic again
Time Frame
end of 10th day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adult 18 or over Meets definition of acute sinusitis by Infectious Disease Society of America (2012) Clinician and participant chose to start antibiotic treatment Exclusion Criteria: Previously enrolled in the study Allergic or intolerant to amoxicillin, penicillin, or amoxicillin/clavulanate 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 Cognitive impairment so that unable to give informed consent or give reliable assessment of improvement 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 Need to hospitalize the patient
Facility Information:
Facility Name
Albany Medical Center Internal Medicine and Pediatrics
City
Latham
State/Province
New York
ZIP/Postal Code
12110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22438350
Citation
Chow AW, Benninger MS, Brook I, Brozek JL, Goldstein EJ, Hicks LA, Pankey GA, Seleznick M, Volturo G, Wald ER, File TM Jr; Infectious Diseases Society of America. IDSA clinical practice guideline for acute bacterial rhinosinusitis in children and adults. Clin Infect Dis. 2012 Apr;54(8):e72-e112. doi: 10.1093/cid/cir1043. Epub 2012 Mar 20.
Results Reference
background
PubMed Identifier
29738561
Citation
Matho A, Mulqueen M, Tanino M, Quidort A, Cheung J, Pollard J, Rodriguez J, Swamy S, Tayler B, Garrison G, Ata A, Sorum P. High-dose versus standard-dose amoxicillin/clavulanate for clinically-diagnosed acute bacterial sinusitis: A randomized clinical trial. PLoS One. 2018 May 8;13(5):e0196734. doi: 10.1371/journal.pone.0196734. eCollection 2018.
Results Reference
derived

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

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