CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 69 enrolled
Drug / intervention
Cephalexin +1 moredrug
Likely dose
Cephalexin 1000 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04471246
NCT04471246Phase 4Completed

High-dose Cephalexin for Cellulitis: A Pilot Randomized Controlled Trial

Ottawa Hospital Research Institute·interventional·Posted Jul 15, 2020·Updated Jan 17, 2025

In Brief

A Phase 4 clinical trial evaluating Cephalexin and Cephalexin + placebo for Cellulitis. Completed, enrolled 69 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCellulitis
CountriesCanada

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedJul 15, 2020
Enrollment StartAug 16, 2021
Primary CompletionFeb 23, 2022
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 6.0 years ago

Interventions

Cephalexindrug

1000 mg PO QID for 7 days

Cephalexin + placebodrug

500 mg PO QID plus oral placebo for 7 days