High-dose vs. Standard-dose Cephalexin for Cellulitis
Status:
Recruiting
Trial end date:
2022-06-01
Target enrollment:
Participant gender:
Summary
Background: Cellulitis is a common clinical condition that represents up to 3% of all
emergency department (ED) visits. The current treatment failure rate is approximately 20%.
This high treatment failure rate may be due to suboptimal dosing of cephalexin. The
Investigators hypothesize that high-dose cephalexin may lead to lower rates of treatment
failure and subsequently improved patient outcomes (less hospitalizations and avoidance of
intravenous antibiotics)
Rationale: Before embarking on a large, multicenter trial, it is essential to conduct a
smaller pilot to test and refine study procedures and to demonstrate feasibility.
Methods:
Design: The investigators will conduct a parallel arm double-blind randomized controlled
pilot trial at the Civic and General campus ED of The Ottawa Hospital (TOH). The study will
operate seven days a week from 0800 to 2000 over a 6-month timeframe. TOH Pharmacy will
follow a randomization sequence and prepare study medication packages. Study medication
packages will be dispensed to the patient by a registered nurse (RN).
Patients: Adult (age >=18 years) ED patient with non-purulent cellulitis determined by the
treating emergency physician to be eligible for outpatient care with oral antibiotics.
Intervention: High-dose cephalexin (1000 mg PO QID) for seven days.
Comparator: Standard-dose cephalexin (500 mg PO QID) plus placebo for seven days.
Primary Feasibility Outcome: Patient recruitment rate (percentage of approached eligible
patients who are successfully recruited). The goal is to recruit at least 29% of eligible
patients.
Primary Effectiveness Outcome: 1. Oral antibiotic treatment failure, defined as a change in
antibiotic (change in class of oral antibiotic or step up to intravenous therapy) within 7
days due to worsening infection, which is defined as:
1. New fever (temperature ≥ 38.0C) or persistent fever at Day 3 follow up; or
2. Increasing area of erythema ≥20% from baseline; or
3. Increasing pain ≥2 points from baseline (numeric rating scale)
The secondary effectiveness outcomes are:
1. Clinical cure (no erythema, pain and fever) at day 7
2. Clinical response (≥20% reduction in area of erythema compared to baseline) at day 3
3. Adverse events (e.g. vomiting, diarrhea, rash) at 14-day telephone follow-up
4. Unplanned i) return ED visits; and ii) hospitalization at 14-day telephone follow-up
Importance: This pilot trial will be the first to compare high-dose cephalexin to
standard-dose cephalexin for ED patients with cellulitis. The results of this pilot
randomized trial will help inform the design and implementation of a larger, multicenter
randomized controlled trial to answer this important clinical question.
Phase:
Phase 4
Details
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborators:
Canadian Association of Emergency Physicians The Ottawa Hospital Academic Medical Association