NCT03431337

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

Treatment of Acute Sinusitis With High-Dose vs. Standard-Dose Amoxicillin/Clavulanate: A Confirmation Study

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 157 (actual)
• Sponsor: Paul Sorum, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sinusitis, Acute

Interventions

Type	Name	Description
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
DIETARY_SUPPLEMENT	Placebo (lactase)	Placebo (in place of additional amoxicillin in experimental arm)

Timeline

• Start date: 2018-02-26
• Primary completion: 2020-05-31
• Completion: 2020-05-31
• First posted: 2018-02-13
• Last updated: 2021-08-12
• Results posted: 2021-08-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study