ClinConnect ClinConnect Logo
Search / Trial NCT05852262

High-dose Cephalexin for Cellulitis (HI-DOCC)

Launched by OTTAWA HOSPITAL RESEARCH INSTITUTE · May 1, 2023

Trial Information

Current as of June 26, 2025

Enrolling by invitation

Keywords

Cellulitis Cephalexin Oral Antibiotics Treatment Failure

ClinConnect Summary

Background Non-purulent cellulitis is a bacterial skin and soft tissue infection of the subcutaneous tissue. Group A streptococcus (Streptococcus pyogenes), beta-hemolytic streptococci and methicillin-susceptible Staphylococcus aureus are the most common bacteria causing non-purulent cellulitis. Patients typically present to the emergency department (ED) with pain, redness, swelling and induration (skin hardening due to inflammation) of the affected skin. A minority of patients may have fever or tachycardia. The diagnosis of cellulitis is clinical. Once the diagnosis is made, antibiotic tre...

Gender

ALL

Eligibility 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

About Ottawa Hospital Research Institute

The Ottawa Hospital Research Institute (OHRI) is a leading academic research institute dedicated to advancing health and healthcare through innovative research and evidence-based practices. Affiliated with The Ottawa Hospital and the University of Ottawa, OHRI fosters a collaborative environment that brings together clinicians, scientists, and trainees to conduct groundbreaking clinical trials and translational research. With a focus on improving patient outcomes, OHRI specializes in a wide range of fields, including cancer, cardiovascular health, and regenerative medicine. The institute is committed to ethical research practices and the dissemination of knowledge to enhance public health and inform healthcare policy.

Locations

London, Ontario, Canada

Calgary, Alberta, Canada

Ottawa, Ontario, Canada

Calgary, Alberta, Canada

Montréal, Quebec, Canada

Kingston, Ontario, Canada

Toronto, Ontario, Canada

Sudbury, Ontario, Canada

Thunder Bay, Ontario, Canada

Halifax, Nova Scotia, Canada

Québec, Quebec, Canada

Patients applied

0 patients applied

Trial Officials

Krishan Yadav, MD

Principal Investigator

Ottawa Hospital Research Institute

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported