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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02340000
First Posted: January 16, 2015
Last Update Posted: August 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Paul Sorum, MD, Albany Medical College
  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 Phase
Sinusitis Drug: standard dose amoxicillin/clavulanate Drug: high dose amoxicillin/clavulanate Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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: day 0, end of 3 days of treatment ]

    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 [ Time Frame: end of 10th day ]
    rating of "a lot better" or "no symptoms"

  • SNOT-16 - Day 10 [ Time Frame: day 0, end of 10th day ]

    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 [ Time Frame: baseline ]
    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 [ Time Frame: end of 10th day ]
    whether participants said they would NOT take the antibiotic again


Enrollment: 315
Actual Study Start Date: November 18, 2014
Study Completion Date: February 27, 2017
Primary Completion Date: February 27, 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
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
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

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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02340000


Locations
United States, New York
Albany Medical Center Internal Medicine and Pediatrics
Latham, New York, United States, 12110
Sponsors and Collaborators
Albany Medical College
  Study Documents (Full-Text)

Documents provided by Paul Sorum, MD, Albany Medical College:
Informed Consent Form  [PDF] July 16, 2017

  More Information

Publications:
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
First Submitted: November 22, 2014
First Posted: January 16, 2015
Results First Submitted: July 16, 2017
Results First Posted: August 24, 2017
Last Update Posted: August 24, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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