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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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
Trial Officials
Krishan Yadav, MD
Principal Investigator
Ottawa Hospital Research Institute
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported