Treatment of Acute Sinusitis With High-Dose vs. Standard-Dose Amoxicillin/Clavulanate
Condition: Sinusitis, Acute
MeSH terms: Sinusitis
Intervention: Amoxicillin 875 mg; Placebo (lactase)
Intervention description: Doubling the dose of amoxicillin by adding amoxicillin 875 to each dose of the standard treatment of amoxicillin/clavulanate 875/125; Placebo (in place of additional amoxicillin in experimental arm)
Intervention MeSH terms: Amoxicillin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
If they do not meet exclusion criteria, they will be offered enrollment in the study.
If they agree, they will be provided unlabeled study medication, either amoxicillin/clavulanate 875/125 + placebo pills bid x 7 days (standard dose) or amoxicillin/clavulanate 875/125 + amoxicillin immediate-release 875 (high dose).
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.
Enrollment: 157.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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. .
    

Eligibility 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)