Clinical Trial of the Treatment of Acute Sinusitis With Standard-dose Versus High-dose Amoxicillin/Clavulanate
1 other identifier
interventional
315
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2014
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 18, 2014
CompletedFirst Submitted
Initial submission to the registry
November 22, 2014
CompletedFirst Posted
Study publicly available on registry
January 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 27, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 27, 2017
CompletedResults Posted
Study results publicly available
August 24, 2017
CompletedAugust 24, 2017
August 1, 2017
2.3 years
November 22, 2014
July 16, 2017
August 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Subjective Improvement - Day 3 (Rating of "a Lot Better" or "no Symptoms")
rating of "a lot better" or "no symptoms"
end of 3 days of treatment
Secondary Outcomes (5)
SNOT-16 - Day 3
day 0, end of 3 days of treatment
Subjective Improvement - Day 10
end of 10th day
SNOT-16 - Day 10
day 0, end of 10th day
Nasal Colonization With Resistant Bacteria
baseline
Willingness to Take the Study Antibiotic in the Future
end of 10th day
Study Arms (2)
standard dose
ACTIVE COMPARATORamoxicillin/clavulanate 875/125 mg + placebo tablet twice a day for 7 days
high dose
EXPERIMENTALTime 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
Interventions
amoxicillin/clavulanate 875/125 + placebo bid x 7 days
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
Eligibility Criteria
You may qualify if:
- Adult 18 or over
- Meets definition of acute sinusitis by Infectious Disease Society of America (2012)
- Clinician and participant chose to start antibiotic treatment
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Albany Medical Center Internal Medicine and Pediatrics
Latham, New York, 12110, United States
Related Publications (2)
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.
PMID: 22438350BACKGROUNDMatho 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.
PMID: 29738561DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
1. Initial formulation of high-dose amox/clav (extended release) became unavailable, so had to switch after participant #180 to immediate-release. 2. The medical students and residents had trouble reaching some participants for follow-up.
Results Point of Contact
- Title
- Paul Sorum, MD
- Organization
- Albany Medical College
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Internal Medicine and Pediatrics
Study Record Dates
First Submitted
November 22, 2014
First Posted
January 16, 2015
Study Start
November 18, 2014
Primary Completion
February 27, 2017
Study Completion
February 27, 2017
Last Updated
August 24, 2017
Results First Posted
August 24, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will not share