drugset / Trial / NCT05852262
High-dose Cephalexin for Cellulitis (HI-DOCC)
Phase 4
Enrolling by invitation
446 enrolled
Ottawa Hospital Research Institute
Network of Canadian Emergency Researchers (NCER) · collabThe Ottawa Hospital Academic Medical Association · collab
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2023-08-30
- Primary completion
- 2025-12
- Completion
- 2026-08-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | CEPHALEXIN ANHYDROUS | Small molecule | 500 mg | Oral |
| Comparator | CEPHALEXIN ANHYDROUS | Small molecule | 1000 mg | Oral |