Phase 4
N=66
High-dose vs. Standard-dose Cephalexin for Cellulitis
Cellulitis
Bottom Line
View on ClinicalTrials.gov: NCT04471246 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Patient Recruitment Rate — 51.5 percentage of eligible patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Cephalexin (Drug); Cephalexin + placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ottawa Hospital Research Institute
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Recruitment Rate |
51.5 | — |
| PRIMARY Oral Antibiotic Treatment Failure |
3.2; 12.9 | — |
| SECONDARY Ability to Approach Eligible Patients |
14.2 | — |
| SECONDARY Assessment of Blinding |
33.3; 60.1 | — |
| SECONDARY Protocol Adherence |
75.8; 75.8 | — |
| SECONDARY Loss to Follow-up |
6.1; 6.1 | — |
| SECONDARY Clinical Cure |
45.2; 38.7; 16.1; 6.5 | — |
| SECONDARY Adverse Events |
9.7; 3.2; 16.1; 6.5; 3.2; 0 | — |
| SECONDARY Unplanned ED Visits or Hospitalization |
6.5; 6.5; 22.6; 16.1; 0; 0 | — |
Summary
Cellulitis is a painful bacterial infection of the skin and underlying tissue that needs antibiotic treatment. There are approximately 193,000 visits to Canadian emergency departments (EDs) each year for cellulitis. Emergency doctors who treat patients with cellulitis must decide on the correct antibiotic agent, dose, duration and frequency. Cellulitis is most commonly treated with the oral antibiotic cephalexin. However, there has been little research to guide doctors with respect to cellulitis treatment, which has led to an overuse of intravenous antibiotics. In addition, the current treatment failure rate of 20% is unacceptably high. When compared to standard-dose oral cephalexin, high-dose oral cephalexin may reduce treatment failure, which would help decrease the need for intravenous antibiotics and subsequent hospitalization. A well-designed clinical trial is necessary to determine if high-dose oral cephalexin reduces treatment failure for cellulitis patients. This pilot trial will determine the feasibility and design of such a clinical trial.
Eligibility Criteria
Inclusion Criteria
Adults (age >=18 years) with non-purulent cellulitis determined by the treating emergency physician to be eligible for outpatient care with oral antibiotics.
Exclusion Criteria
- Age =38C plus absolute neutrophil count <500 cells/uL)
- Solid organ or bone marrow transplant recipient
- Renal impairment with creatinine clearance <30 mL/min
- Pregnant or breastfeeding
- Allergy to cephalosporins or history of anaphylaxis to penicillin
- Inability to provide consent
Data sourced from ClinicalTrials.gov (NCT04471246). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.