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High-dose vs. Standard-dose Cephalexin for Cellulitis

NCT04471246 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2025-01-17

Study results available
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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.

Conditions

  • Cellulitis

Interventions

DRUG

Cephalexin

1000 mg PO QID for 7 days

DRUG

Cephalexin + placebo

500 mg PO QID plus oral placebo for 7 days

Sponsors & Collaborators

  • The Ottawa Hospital Academic Medical Association

    collaborator OTHER

  • Canadian Association of Emergency Physicians

    collaborator INDUSTRY

  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • Krishan Yadav, MD, MSc · Ottawa Hospital Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-16
Primary Completion
2022-02-23
Completion
2022-02-23

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04471246 on ClinicalTrials.gov