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NCT Number: NCT02340000

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

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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Key information

Conditions

Sinusitis Infections Nose Diseases Otorhinolaryngologic Diseases Paranasal Sinus Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Albany Medical Center Internal Medicine and Pediatrics

Latham, New York, 12110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

standard dose amoxicillin/clavulanate

Drug

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

high dose amoxicillin/clavulanate

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

Primary outcomes

  1. 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 outcomes

  1. 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).

  2. Subjective Improvement - Day 10

    Time frame: end of 10th day

    rating of "a lot better" or "no symptoms"

  3. 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).

  4. 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).

  5. 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

Sponsors and collaborators

Lead sponsor

Albany Medical College

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jan 16, 2015
Registry last updated
Aug 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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