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

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2016 by Paul Sorum, MD, Albany Medical College
Sponsor:
Information provided by (Responsible Party):
Paul Sorum, MD, Albany Medical College
ClinicalTrials.gov Identifier:
NCT02340000
First received: November 22, 2014
Last updated: July 17, 2016
Last verified: July 2016
  Purpose
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.

Condition Intervention
Sinusitis Drug: standard dose amoxicillin/clavulanate Drug: high dose amoxicillin/clavulanate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Trial of the Treatment of Acute Sinusitis With Standard-dose Versus High-dose Amoxicillin/Clavulanate

Resource links provided by NLM:


Further study details as provided by Paul Sorum, MD, Albany Medical College:

Primary Outcome Measures:
  • subjective improvement - day 3 (rating of "a lot better" or "no symptoms") [ Time Frame: end of 3 days of treatment ]
    rating of "a lot better" or "no symptoms"


Secondary Outcome Measures:
  • SNOT-16 - day 3 [ Time Frame: end of 3 days of treatment ]
    mean improvement of 0.5 or greater on each of the 16 questions

  • subjective improvement - day 10 (rating of "a lot better" or "no symptoms") [ Time Frame: end of 10th day ]
    rating of "a lot better" or "no symptoms"

  • SNOT-16 - day 10 [ Time Frame: end of 10th day ]
    mean improvement of 0.5 or greater on each of the 16 questions

  • side effects - day 3 (proportions with diarrhea, rash, vaginal candidiasis, or other side effect) [ Time Frame: end of 3 days of treatment ]
    proportions with diarrhea, rash, vaginal candidiasis, or other side effect

  • side effects - day 10 (proportions with diarrhea, rash, vaginal candidiasis, or other side effect) [ Time Frame: end of 10th day ]
    proportions with diarrhea, rash, vaginal candidiasis, or other side effect

  • nasal colonization with resistant bacteria [ Time Frame: at the end of the study, i.e. 2 years from start of study (or whenever 300 participants have been enrolled) (results of cultures not available to investigators until end of trial) ]
    identification of participants with nasal carriage of pathogens resistant to study medication

  • success of participant blinding (success of participants in guessing which treatment they received) [ Time Frame: end of 10th day ]
    success of participants in guessing which treatment they received


Estimated Enrollment: 300
Study Start Date: November 2014
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: standard dose
amoxicillin/clavulanate 875/125 mg + placebo tablet twice a day for 7 days
Drug: standard dose amoxicillin/clavulanate
amoxicillin/clavulanate 875/125 + placebo bid x 7 days
Experimental: high dose
amoxicillin/clavulanate 1000/62.5 mg 2 tablets (by different manufacturer) twice a day for 7 days
Drug: high dose amoxicillin/clavulanate
amoxicillin/clavulanate 1000/62.5 two tablets (different manufacturers) bid x 7 days

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02340000

Locations
United States, New York
Albany Medical Center Internal Medicine and Pediatrics Recruiting
Latham, New York, United States, 12110
Contact: Paul Sorum, MD    518-262-7500    sorump@mail.amc.edu   
Contact: David Bounds    518-262-7500    boundsd@mail.amc.edu   
Principal Investigator: Paul Sorum, MD         
Sub-Investigator: Gina Garrison, PharmD         
Sub-Investigator: Mary Mulqueen, MD         
Sub-Investigator: Andrea Matho, MD         
Sub-Investigator: Miyuki Tanino, MD         
Sub-Investigator: Aaron Quidort, MD         
Sub-Investigator: Sujata Kane, PA-C         
Sub-Investigator: Christine McGovern, PA-C         
Sponsors and Collaborators
Albany Medical College
  More Information

Responsible Party: Paul Sorum, MD, Professor of Internal Medicine and Pediatrics, Albany Medical College
ClinicalTrials.gov Identifier: NCT02340000     History of Changes
Other Study ID Numbers: 3968
Study First Received: November 22, 2014
Last Updated: July 17, 2016

Keywords provided by Paul Sorum, MD, Albany Medical College:
acute sinusitis
amoxicillin/clavulanate
adults
outcomes

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Amoxicillin
Clavulanic Acid
Clavulanic Acids
Amoxicillin-Potassium Clavulanate Combination
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 21, 2017