High-dose Cephalexin for Cellulitis (HI-DOCC)

NCT05852262 | Enrolling By Invitation Phase 4 DMC

• 1 other identifier: 20230205-01T
• Study Type: interventional
• Target: 446
• Locations: 1 country
• Sites: 10

Brief 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. The Investigators 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, The investigators found that the mean cost of care to hospitalize cellulitis patients for IV antibiotics was $10,145 CDN.

Conditions

Cellulitis

Keywords

Cellulitis; Cephalexin; Oral antibiotics; Treatment failure

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Oral Antibiotic Treatment Failure

  defined as a change in antibiotic (change in class of oral antibiotic or step up to IV therapy) within 7 days due to worsening infection. Any of the following meet criteria for worsening infection (at day 3 or 8 follow-up): (1) New fever (temperature ≥38.0C) or persistent fever at follow-up; (2) Increasing area of erythema (in cm2) ≥20% from baseline; or (3) Increasing pain ≥2 points from baseline (using the numeric rating scale).

  7 days

Secondary Outcomes (12)

• Number of Participants with clinical cure

  evaluated at day 8 and day 30

• Number of Participants with clinical response

  evaluated at days 3 and 8

• Number of Participants with unplanned visits to a healthcare provider for cellulitis

  30 days

• Number of Participants with unplanned hospitalization for cellulitis

  30 days

• Number of Participants with adverse events

  30 days

Study Arms (2)

High Dose Cephalexin

EXPERIMENTAL

The intervention is high-dose cephalexin (1000mg PO QID) for seven days

Drug: Cephalexin

Standard Dose Cephalexin

ACTIVE COMPARATOR

The comparator is standard-dose cephalexin (500mg PO QID) plus oral placebo for seven days

Drug: Cephalexin

Interventions

Cephalexin DRUG

1000 mg PO QID for 7 days

Also known as: High-dose cephalexin

High Dose Cephalexin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Age \<18 years;
• Patient already taking oral antibiotics;
• Treating physician decides IV antibiotics are required;
• Abscess requiring an incision and drainage procedure;
• Known prior skin or soft tissue infection secondary to methicillin-resistant Staphylococcus aureus (MRSA);
• Cellulitis secondary to a human or animal bite wound;
• Penetrating wound or water exposure resulting in cellulitis;
• Surgical site infection;
• Patient found at a follow up visit to have an alternative, non-infectious etiology (e.g., deep vein thrombosis);
• bilateral symptoms (e.g., both legs involved);
• Malignancy and currently being treated with chemotherapy;
• Solid organ or bone marrow transplant recipient;
• Renal impairment with an estimated glomerular filtration rate \<30 mL/min documented on the health record at any time within the past three months;
• Allergy to cephalosporins or history of anaphylaxis to penicillin;
• Inability to provide informed consent

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Network of Canadian Emergency Researchers (NCER): collaborator
• The Ottawa Hospital Academic Medical Association: collaborator

Study Sites (10)

South Health Campus

Calgary, Alberta, Canada

Location

Queen Elisabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada

Location

Health Sciences North

Greater Sudbury, Ontario, P3E 2H2, Canada

Location

Kingston Health Sciences Centre

Kingston, Ontario, Canada

Location

London Health Sciences Centre

London, Ontario, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location

Thunder Bay Health Sciences Centre

Thunder Bay, Ontario, Canada

Location

Sinai Health System

Toronto, Ontario, Canada

Location

Hôpital du Sacré-Cœur de Montréal

Montreal, Quebec, Canada

Location

Enfant-Jésus Hospital

Québec, Quebec, Canada

Location

MeSH Terms

Conditions

Cellulitis

Interventions

Cephalexin

Condition Hierarchy (Ancestors)

Skin Diseases, Infectious; Infections; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Krishan Yadav, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Eligible patients will be randomized (1:1) to high-dose versus standard-dose arms. The randomization sequence will be computer-generated by a statistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The Investigators will conduct a parallel arm double-blind randomized controlled trial.

Study Record Dates

• First Submitted: May 1, 2023
• First Posted: May 10, 2023
• Study Start: August 30, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (10)