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Treatment of Acute Sinusitis With High-Dose vs. Standard-Dose Amoxicillin/Clavulanate

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ClinicalTrials.gov Identifier: NCT03431337
Recruitment Status : Recruiting
First Posted : February 13, 2018
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
Paul Sorum, MD, Albany Medical College

Brief Summary:
Comparative-effectiveness study of the treatment of acute bacterial sinusitis with amoxicillin/clavulanate 875mg/125mg bid for 7 days with or without the addition of immediate-release amoxicillin 875 mg bid x 7 days. .

Condition or disease Intervention/treatment Phase
Sinusitis, Acute Drug: Amoxicillin 875 mg Dietary Supplement: Placebo (lactase) Phase 4

Detailed Description:
Double-blind comparative-effectiveness study of the treatment of acute bacterial sinusitis with standard dose of amoxicillin/clavulanate 875mg/125mg bid for 7 days, as recommended by the Infectious Disease Society of America, with or without the addition of immediate-release amoxicillin 875 mg bid x 7 days. The study aims are 1) to confirm, or not, our recent findings of more rapid improvement in overall symptoms with the additional amoxicillin, but also of more frequent diarrhea and vaginal yeast infections and 2) to assess, from the participants' point of view, the balance between improvement and adverse effects.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
  1. Ill adult patients coming to a primary care office will be diagnosed by the treating physicians with acute bacterial sinusitis in accordance with the guidelines of the Infectious Disease Society of America.
  2. If they do not meet exclusion criteria, they will be offered enrollment in the study.
  3. If they agree, they will be provided unlabeled study medication, either amoxicillin/clavulante 875/125 + placebo pills bid x 7 days (standard dose) or amoxicillin/clavulanate 875/125 + amoxicillin immediate-release 875 (high dose).
  4. Outcomes will be assessed, by telephone or over the web (through Qualtrics), at 3 and 10 days after enrollment.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Unlabeled bottles of study medications, identified only by participant #, prepared by the pharmacist member of research team. The placebo will be similar in appearance to plain amoxicillin. The pills inside the bottle will be difficult to see until the bottle is opened by the patient.
Primary Purpose: Treatment
Official Title: Treatment of Acute Sinusitis With High-Dose vs. Standard-Dose Amoxicillin/Clavulanate: A Confirmation Study
Actual Study Start Date : February 26, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis

Arm Intervention/treatment
Experimental: High dose
Amoxicillin/clavulanate 875mg/125mg & amoxicillin 875 mg twice a day x 7 days
Drug: Amoxicillin 875 mg
Doubling the dose of amoxicillin by adding amoxicillin 875 to each dose of the standard treatment of amoxicillin/clavulanate 875/125
Other Name: Amoxil

Active Comparator: Standard dose
Amoxicillin/clavulanate 875 mg/125mg & placebo (lactase) twice a day x 7 days.
Dietary Supplement: Placebo (lactase)
Placebo (in place of additional amoxicillin in experimental arm)




Primary Outcome Measures :
  1. Global rating of improvement at 3 days [ Time Frame: At end of 3 days of treatment ]
    Rating on a scale of 1=a lot worse, 2=a little worse, 3=the same, 4=a little better, 5=a lot better, 6=no symptoms


Secondary Outcome Measures :
  1. Global rating of improvement at 10 days [ Time Frame: At end of 10 days since enrollment ]
    Rating on scale of 1-6 (as above)

  2. Sinonasal Outcome Test-16 (SNOT-16) at 3 days [ Time Frame: At end of 3 days of treatment ]
    Ratings on scale of 0-4 of 16 symptoms in comparison with ratings at enrollment

  3. SNOT-16 at 10 days [ Time Frame: At end of 10 days since enrollment ]
    Ratings of 16 symptoms in comparison with ratings at enrollment

  4. Adverse effects at 3 days [ Time Frame: At end of 3 days of treatment ]
    Ratings on scale of 0=none to 3=severe of diarrhea, abdominal pain, vaginal itching and discharge (for women), and rash

  5. Adverse effects at 10 days [ Time Frame: At end of 10 days since enrollment ]
    Ratings of adverse effects as above

  6. Balance of benefits and detriments [ Time Frame: At end of 10 days since enrollment ]
    Assessment of balance between good effects and bad effects of antibiotic on scale of -3=bad effects much greater than good effects to +3=good effects much greater than bad effects

  7. Future preference [ Time Frame: At end of 10 days since enrollment ]
    Response to question whether would take this antibiotic again: yes, no, uncertain


Other Outcome Measures:
  1. Effectiveness of blinding [ Time Frame: At end of 10 days since enrollment ]
    Responses to question of which dose participants think they took (standard-dose, high-dose, or uncertain) and why they think this

  2. Amount of medication taken [ Time Frame: At end of 10 days since enrollment ]
    Responses to question of how many doses they took and, if they did not take all doses, why not



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adults 18 and older who are patients at the Albany Medical Center Internal Medicine and Pediatrics practice (study site).
  2. Clinical diagnosis of acute bacterial sinusitis in accordance with the guidelines of the Infectious Disease Society of America (fitting into one of 3 categories: persistent sinus symptoms for 10 days or more; severe sinus symptoms for 3 days or more; or worsening sinus symptoms after initial improvement (double sickening).

Exclusion Criteria:

  1. Previous enrollment in the current study
  2. Allergy or intolerance to any penicillin or to amoxicillin/clavulanate
  3. Serious hypersensitivity reaction to any beta lactam
  4. Elevated risk of amoxicillin-resistant bacteria: a. amoxicillin, penicillin, or other beta-lactam within the past month; b. known to have had methicillin-resistant Staph aureus
  5. Chronic or recurrent "sinus" problems (defined as a) persistent symptoms of "sinus" congestion, not attributed to nasal allergies, for 8 weeks or more or b) 2 or more episodes of antibiotic-treated "sinusitis" in past 3 months
  6. Need to use high-dose amoxicillin/clavulanate or levofloxacin or to send to emergency department or to hospitalize because of a) signs of severe infection or b) immunocompromise
  7. Cognitive impairment, so unable to give reliable symptom ratings (even if a health proxy can give consent)
  8. Pregnant women and nursing mothers
  9. Drug warnings: a) taking allopurinol; b) current mononucleosis; c) chronic kidney disease stage 4 (estimated glomerular filtration rate <30); d) hepatic impairment (not including isolated transaminase elevated < 2 times upper limit of normal); e) history of antibiotic-associated colitis (C. difficile)

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): NCT03431337


Contacts
Contact: Paul C Sorum, MD, PhD 518-262-7500 sorump@amc.edu
Contact: Danielle Wales, MD, MPH 518-262-7500 walesd@amc.edu

Locations
United States, New York
Albany Medical Center Internal Medicine and Pediatrics Recruiting
Cohoes, New York, United States, 12047
Contact: Paul C Sorum, MD, PhD    518-262-7500    sorump@amc.edu   
Contact: Danielle Wales, MD, MPH    5182627500    walesd@amc.edu   
Sub-Investigator: Jennifer Gregory, MD         
Sub-Investigator: Bichtram Huynh, MD         
Sub-Investigator: Gina Garrison, PharmD         
Sub-Investigator: Jennifer Cha         
Sub-Investigator: Chaitali Korgaonkar         
Sponsors and Collaborators
Paul Sorum, MD
Investigators
Principal Investigator: Paul C Sorum, MD, PhD Albany Medical College

Publications:
Responsible Party: Paul Sorum, MD, Professor of Internal Medicine and Pediatrics, Albany Medical College
ClinicalTrials.gov Identifier: NCT03431337     History of Changes
Other Study ID Numbers: 4993
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: At end of study, will ask Institutional Review Board for permission to make de-identified data available to other researchers

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

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