High-Dose Cephalexin for Cellulitis

(HI-DOCC Trial)

Recruiting at 10 trial locations

Overseen by Krishan Yadav, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Ottawa Hospital Research Institute

No Placebo Group

Prior Safety Data

Approved in 5 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Krishan Yadav, MD

Principal Investigator

Ottawa Hospital Research Institute

Eligibility Criteria

This trial is for adults over 18 with non-purulent cellulitis who can take oral antibiotics at home. It's not for those under 18, on current antibiotics, needing IV treatment or surgery, with a history of MRSA-related cellulitis, cephalosporin allergy, unable to consent, undergoing chemotherapy for cancer, having symptoms in both legs, from penetrating wounds or water exposure related infections or severe kidney issues.

Inclusion Criteria

I am 18 or older with cellulitis and can be treated with oral antibiotics at home.

Exclusion Criteria

My kidney function is significantly reduced.

I have an infection at a recent surgery site.

My doctor has prescribed IV antibiotics for me.

Treatment Details

Interventions

• Cephalexin (Cephalosporin Antibiotic)

Trial Overview The HI-DOCC study tests whether high doses of Cephalexin are effective in treating cellulitis without hospital admission. The goal is to see if this approach can reduce the healthcare burden by managing more cases as outpatients.

Participant Groups

Group I: High Dose Cephalexin Experimental Treatment 1 Intervention

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

Group II: Standard Dose Cephalexin Active Control 1 Intervention

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

Cephalexin is already approved in Canada, Switzerland for the following indications:

Approved in Canada as Keflex for:

• Respiratory tract infections
• Otitis media
• Skin and skin structure infections
• Bone infections
• Genitourinary tract infections

Approved in Switzerland as Keflex for:

• Respiratory tract infections
• Otitis media
• Skin and skin structure infections
• Bone infections
• Genitourinary tract infections

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

The Ottawa Hospital Academic Medical Association

Collaborator

Trials

24

Recruited

3,000+

Network of Canadian Emergency Researchers (NCER)

Collaborator

Trials

1

Recruited

450+