High-Dose Cephalexin for Cellulitis: A Randomized Controlled Trial

• Status: Not yet recruiting
• Trial end date: 2026-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Cellulitis is a common condition diagnosed and managed in the ED that carries significant burden on healthcare systems globally. Cellulitis is the 8th most common reason patients present to an ED in Canada. Among middle-aged patients (45-64 years) it is the 5th most common reason to visit an ED. This disease is responsible for significant healthcare system burden due to high hospitalization rates and subsequent costs. We conducted a health records review at two large urban EDs in Ottawa, and found that 29.6% of patients with cellulitis are admitted to hospital. In a separate study, we found that the mean cost of care to hospitalize cellulitis patients for IV antibiotics was $10,145 CDN.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ottawa Hospital Research Institute
• Collaborators: Network of Canadian Emergency Researchers (NCER); The Ottawa Hospital Academic Medical Association
• Treatments: Cephalexin

Criteria

Inclusion Criteria:

Adults (age ≥18 years) diagnosed with non-purulent cellulitis and determined by the treating emergency physician to be eligible for outpatient oral antibiotics.

Exclusion Criteria:

1. Age <18 years;

2. Patient already taking oral antibiotics;

3. Treating physician decides IV antibiotics are required;

4. Abscess requiring an incision and drainage procedure;

5. Known prior cellulitis secondary to methicillin-resistant Staphylococcus aureus (MRSA);

6. Cellulitis secondary to a human or animal bite wound;

7. Penetrating wound or water exposure resulting in cellulitis;

8. Surgical site infection;

9. Patient found at a follow up visit to have an alternative, non-infectious etiology (e.g., deep vein thrombosis);

10. bilateral symptoms (e.g., both legs involved);

11. Malignancy and currently being treated with chemotherapy;

12. Solid organ or bone marrow transplant recipient;

13. Renal impairment with an estimated glomerular filtration rate <30 mL/min documented on the health record at any time within the past three months;

14. Allergy to cephalosporins or history of anaphylaxis to penicillin;

15. Inability to provide informed consent