NCT01029782

Brief Summary

The purpose of this study is to determine whether oral cephalexin is equivalent to intravenous cefazolin plus oral probenecid for the treatment of uncomplicated skin and soft tissue infections in patients that present to the emergency department.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2010

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 10, 2009

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

August 13, 2018

Completed
Last Updated

August 13, 2018

Status Verified

August 1, 2018

Enrollment Period

4.4 years

First QC Date

December 9, 2009

Results QC Date

October 6, 2017

Last Update Submit

August 10, 2018

Conditions

Cellulitis

Keywords

CellulitisEmergency DepartmentCefazolinProbenecidCephalexin

Outcome Measures

Primary Outcomes (1)

  • The Number of Patients Failing Therapy After 72 Hours of Antibiotic Treatment With Oral Cephalexin or Intravenous Cefazolin Plus Oral Probenecid.

    72 hours

Study Arms (2)

IV cefazolin plus oral probenecid and placebo cephalexin

ACTIVE COMPARATOR
Drug: IV cefazolin plus oral probenecid and placebo cephalexin

Oral cephalexin and saline IV plus probenecid placebo

ACTIVE COMPARATOR
Drug: Oral cephalexin and saline IV plus probenecid placebo

Interventions

IV cefazolin plus oral probenecid and placebo cephalexinDRUG

Intravenous cefazolin 2 g IV plus probenecid 1 g daily plus cephalexin placebo orally four times daily.

IV cefazolin plus oral probenecid and placebo cephalexin
Oral cephalexin and saline IV plus probenecid placeboDRUG

Cephalexin 500 mg orally four times daily plus saline IV and oral probenecid placebo daily

Oral cephalexin and saline IV plus probenecid placebo

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients presenting to the emergency department with a presumed diagnosis of mild to moderate skin and soft tissue infection
  • Deemed well enough to be treated as an outpatient
  • years of age or older

You may not qualify if:

  • known allergy to study drugs
  • known chronic kidney disease with a creatinine clearance \<30 mL/min
  • known previous methicillin-resistant staphylococcus aureus (MRSA) infection
  • use of antibiotics for greater than 24 hours in the past 7 days
  • wound/abscess requiring operative debridement or incision and drainage
  • suspected necrotizing fasciitis, osteomyelitis or septic arthritis
  • febrile neutropenia
  • concomitant documented bacteremia
  • Two or more signs of systemic sepsis
  • new altered mental status
  • infections at a site involving prosthetic materials
  • animal or human bite wound infections
  • post-operative wound infections
  • known peripheral vascular disease
  • superficial thrombophlebitis
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kelowna General Hospital

Kelowna, British Columbia, V1Y 1T2, Canada

Location

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Related Publications (1)

  • Dalen D, Fry A, Campbell SG, Eppler J, Zed PJ. Intravenous cefazolin plus oral probenecid versus oral cephalexin for the treatment of skin and soft tissue infections: a double-blind, non-inferiority, randomised controlled trial. Emerg Med J. 2018 Aug;35(8):492-498. doi: 10.1136/emermed-2017-207420. Epub 2018 Jun 18.

    PMID: 29914924DERIVED

MeSH Terms

Conditions

CellulitisEmergencies

Interventions

CefazolinProbenecidCephalexin

Condition Hierarchy (Ancestors)

Skin Diseases, InfectiousInfectionsSuppurationConnective Tissue DiseasesSkin and Connective Tissue DiseasesInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Intervention Hierarchy (Ancestors)

Cephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsSulfonamidesSulfones

Results Point of Contact

Title
Dawn Dalen
Organization
Interior Health
dawn.dalen@interiorhealth.ca
250-862-4449

Study Officials

  • Dawn Dalen, PharmD

    Interior Health

    PRINCIPAL INVESTIGATOR

  • Peter Zed, PharmD

    Capital Health, Canada

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Pharmacy Specialist, Emergency Medicine

Study Record Dates

First Submitted

December 9, 2009

First Posted

December 10, 2009

Study Start

May 1, 2010

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

August 13, 2018

Results First Posted

August 13, 2018

Record last verified: 2018-08

Locations

CA(2)