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

Phase 4

Terminated

Conditions: Sinusitis, Acute

Interventions: Drug: Amoxicillin 875 mg
Dietary Supplement: Placebo (lactase)

Registration Number: NCT03431337

Lead Sponsor: Paul Sorum, MD

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. .

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 157

Inclusion Criteria

Adults 18 and older who are patients at the Albany Medical Center Internal Medicine and Pediatrics practice (study site).
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

Previous enrollment in the current study
Allergy or intolerance to any penicillin or to amoxicillin/clavulanate
Serious hypersensitivity reaction to any beta lactam
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
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
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
Cognitive impairment, so unable to give reliable symptom ratings (even if a health proxy can give consent)
Pregnant women and nursing mothers
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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High dose	Amoxicillin 875 mg	Amoxicillin/clavulanate 875mg/125mg \& amoxicillin 875 mg twice a day x 7 days
Standard dose	Placebo (lactase)	Amoxicillin/clavulanate 875 mg/125mg \& placebo (lactase) twice a day x 7 days.

Primary Outcome Measures

Name	Time	Method
Number of Participants With a Global Rating of Improvement of 5 & 6 at the End of 3 Days of Treatment	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, with a higher score indicating greater improvement.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in the Total Score on the Sinonasal Outcome Test-16 (SNOT-16) at the End of 3 Days of Treatment	At end of 3 days of treatment	The change between enrollment and the end of 3 days of treatment in the total score on the Sinonasal Outcome Test-16 (SNOT-16). The total SNOT-16 is the sum of the participant's ratings of 16 symptoms of illness on the scale of 0 (no problem) to 3 (severe problem), with a possible range of 0 to 48, with a higher sum indicating more troubling symptoms. A decrease in total score would indicate an improvement in symptoms.
Number of Participants With a Global Rating of Improvement of 5 or 6 at End of 10 Days Since Enrollment	At end of 10 days since enrollment	Rating of 5 (a lot better) or 6 (no symptoms) on Global Rating of Improvement scale, with range of 1 (a lot worse) to 6 (no symptoms), with a higher score indicating greater improvement
Change From Baseline in the Total Score on the Sinonasal Outcome Test-16 (SNOT-16) at the End of 10 Days Since Enrollment	At end of 10 days since enrollment	The change between enrollment and the end of 10 days since enrollment in the total score on the Sinonasal Outcome Test-16 (SNOT-16). The total SNOT-16 is the sum of the participant's ratings of 16 symptoms of illness on the scale of 0 (no problem) to 3 (severe problem), with a possible range of 0 to 48, with a higher sum indicating more troubling symptoms. A decrease in total score would indicate an improvement in symptoms.
Balance of Benefits and Detriments	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
Number of Participants Answering "Yes" to Willingness to Take the Antibiotic Again in the Future	At end of 10 days since enrollment	Response of "yes" at the end of 10 days since enrollment to the question whether the participant would take this antibiotic again, with possible answers of yes, no, or uncertain.