CellulitisPhase 2NCT01029782
Comparison of Intravenous Cefazolin Plus Oral Probenecid With Oral Cephalexin for the Treatment of Cellulitis
A Phase 2 study of Cellulitis, run by Kelowna General Hospital at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cellulitis
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 206 participants
- Where
- 2 sitesCanada
- Study dates
- May 2010to Oct 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 19 years of age or older
Who cannot join
- 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
Show all 17Show fewer
- 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
- pregnant/breastfeeding
- obesity (BMI > 30 kg/m2)
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 1V7
Kelowna General Hospital
Kelowna, British Columbia, V1Y 1T2
About this study
Official title: Intravenous Cefazolin Plus Oral Probenecid vs. Oral Cephalexin for the Treatment of Cellulitis: a Randomized Controlled Trial
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.
Read the detailed description
Skin and soft tissue infections (SSTIs) are a common reason for presentation to an Emergency Department (ED) in Canada. Although many patients with mild SSTI are able to be managed at home with oral antibiotics, those with mild-moderate infections are often treated with parenteral antibiotics. Current practice patterns in Canadian EDs indicate this patient population is often treated with intravenous cefazolin once daily along with oral probenecid and return to the ED or other ambulatory setting for daily medication administration and assessment. This parenteral regimen has been found to result in success rates comparable to studies which have evaluated treatment success with oral antibiotics in this patient population (89-97%). Although successful outcome can be achieved with this approach, it is often inconvenient for the patient to return to the ED/ambulatory care unit daily and does contribute to overall ED/ambulatory care visit volumes and overall health care costs. Unfortunately, there has never been a study which has evaluated the relative efficacy and safety or oral antibiotics to the aforementioned parenteral approach in this patient population and thus there remains a significant knowledge gap which must be addressed before a change in current practice can be explored.
The objective of the study is to determine whether oral cephalexin is equivalent to intravenous cefazolin plus oral probenecid for the treatment of uncomplicated SSTIs in patients that present to the ED. This study will be a prospective, multi-centered, randomized controlled non-inferiority trial comparing cephalexin 500 mg orally four times to cefazolin 2 g IV plus probenecid 1 g orally, in patients presenting to the ED with presumed diagnosis of SSTI. The primary outcome will be to compare the proportion of patients failing therapy for their cellulitis after 72 hours of antibiotic treatment with oral cephalexin or IV cefazolin/oral probenecid 1 g daily. Secondary outcomes include the clinical cure rate at 7 days, percentage of patients requiring hospital admission, percentage of patients stepped down to oral antibiotics on or before day 7 of therapy, percentage of patients requiring an additional antibiotic prescription on day 7, and the frequency of adverse events.
- Conditions
- Cellulitis
- Being tested
- IV cefazolin plus oral probenecid and placebo cephalexin, Oral cephalexin and saline IV plus probenecid placebo
- Keywords
- Cellulitis, Emergency Department, Cefazolin, Probenecid, Cephalexin
- Medical subject headings
- Cellulitis, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Oral cephalexin and saline IV plus probenecid placeboDrug
Cephalexin 500 mg orally four times daily plus saline IV and oral probenecid placebo daily
| Study group | Role | What they receive |
|---|---|---|
| IV cefazolin plus oral probenecid and placebo cephalexin | Active comparator | Not described Receives: Drug: IV cefazolin plus oral probenecid and placebo cephalexin |
| Oral cephalexin and saline IV plus probenecid placebo | Active comparator | Not described Receives: Drug: Oral cephalexin and saline IV plus probenecid placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Patients Failing Therapy After 72 Hours of Antibiotic Treatment With Oral Cephalexin or Intravenous Cefazolin Plus Oral Probenecid.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2009 (estimated)
- Study startMay 2010
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CellulitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kelowna General Hospital
- Sponsor type
- Other government
- Collaborators
- Canadian Society of Hospital Pharmacists, Capital Health, Canada, Interior Health Authority, Canada
- Responsible party
- Principal investigator, Dawn Dalen, Kelowna General Hospital
- Investigators
- Dawn Dalen, PharmD, Principal investigator, Interior HealthPeter Zed, PharmD, Principal investigator, Capital Health, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01029782
- Sponsor's protocol ID
- KGHQEII-0001
- Status last verified
- Aug 2018
- First submitted
- 9 Dec 2009
- Last updated
- 13 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 29914924
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Cefazolin Plus Oral Probenecid vs. Oral Cephalexin for the Treatment of Cellulitis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01029782
- Acronym / sponsor ID
- KGHQEII-0001
- Conditions
- Cellulitis
- Keywords
- Cellulitis, Emergency Department, Cefazolin, Probenecid, Cephalexin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Kelowna General HospitalOther government
- Collaborators
- Canadian Society of Hospital Pharmacists, Capital Health, Canada, Interior Health Authority, Canada
- Study start
- May 2010
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 10 Dec 2009 (estimated)
- Results
- Posted 13 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Skin and soft tissue infections (SSTIs) are a common reason for presentation to an Emergency Department (ED) in Canada. Although many patients with mild SSTI are able to be managed at home with oral antibiotics, those with mild-moderate infections are often treated with parenteral antibiotics. Current practice patterns in Canadian EDs indicate this patient population is often treated with intravenous cefazolin once daily along with oral probenecid and return to the ED or other ambulatory setting for daily medication administration and assessment. This parenteral regimen has been found to result in success rates comparable to studies which have evaluated treatment success with oral antibiotics in this patient population (89-97%). Although successful outcome can be achieved with this approach, it is often inconvenient for the patient to return to the ED/ambulatory care unit daily and does contribute to overall ED/ambulatory care visit volumes and overall health care costs. Unfortunately, there has never been a study which has evaluated the relative efficacy and safety or oral antibiotics to the aforementioned parenteral approach in this patient population and thus there remains a significant knowledge gap which must be addressed before a change in current practice can be explored.
The objective of the study is to determine whether oral cephalexin is equivalent to intravenous cefazolin plus oral probenecid for the treatment of uncomplicated SSTIs in patients that present to the ED. This study will be a prospective, multi-centered, randomized controlled non-inferiority trial comparing cephalexin 500 mg orally four times to cefazolin 2 g IV plus probenecid 1 g orally, in patients presenting to the ED with presumed diagnosis of SSTI. The primary outcome will be to compare the proportion of patients failing therapy for their cellulitis after 72 hours of antibiotic treatment with oral cephalexin or IV cefazolin/oral probenecid 1 g daily. Secondary outcomes include the clinical cure rate at 7 days, percentage of patients requiring hospital admission, percentage of patients stepped down to oral antibiotics on or before day 7 of therapy, percentage of patients requiring an additional antibiotic prescription on day 7, and the frequency of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
- 19 years of age or older
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IV cefazolin plus oral probenecid and placebo cephalexinIntravenous cefazolin 2 g IV plus probenecid 1 g daily plus cephalexin placebo orally four times daily. | Drug | IV cefazolin plus oral probenecid and placebo cephalexin |
| Oral cephalexin and saline IV plus probenecid placeboCephalexin 500 mg orally four times daily plus saline IV and oral probenecid placebo daily | Drug | Oral cephalexin and saline IV plus probenecid placebo |
Primary outcome
The Number of Patients Failing Therapy After 72 Hours of Antibiotic Treatment With Oral Cephalexin or Intravenous Cefazolin Plus Oral Probenecid.
Time frame: 72 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29914924Dalen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dawn Dalen, PharmD principal investigator
Interior Health
Peter Zed, PharmD principal investigator
Capital Health, Canada
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Cellulitis, run by Kelowna General Hospital at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of Patients Failing Therapy After 72 Hours of Antibiotic Treatment With Oral Cephalexin or Intravenous Cefazolin Plus Oral Probenecid. (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01029782, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2018.