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

Paul Sorum, MD

Status and phase: Terminated; Phase 4

Conditions: Sinusitis, Acute

Treatments: Dietary Supplement: Placebo (lactase); Drug: Amoxicillin 875 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03431337

4993

Details and patient eligibility

About

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. .

Full 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.

Enrollment: 157 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

157 participants in 2 patient groups

High dose

Experimental group

Description:

Amoxicillin/clavulanate 875mg/125mg & amoxicillin 875 mg twice a day x 7 days

Treatment:

Drug: Amoxicillin 875 mg

Standard dose

Active Comparator group

Description:

Amoxicillin/clavulanate 875 mg/125mg & placebo (lactase) twice a day x 7 days.

Treatment:

Dietary Supplement: Placebo (lactase)