Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000682044
Ethics application status
Approved
Date submitted
18/08/2010
Date registered
18/08/2010
Date last updated
18/08/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Flucloxacillin in Cellulitis: A randomised controlled trial comparing continuous infusion to bolus dosing for uncomplicated cellulitis.
Scientific title
In an adult population with uncomplicated cellulitis presenting to an Emergency Department is flucloxacillin delivered by infusion comparable to bolus dosing for nursing workload and patient discharge at 24 hours?
Secondary ID [1] 252507 0
Nil
Universal Trial Number (UTN)
Trial acronym
FliC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cellulitis 257994 0
Condition category
Condition code
Skin 258159 258159 0 0
Other skin conditions
Infection 258160 258160 0 0
Other infectious diseases
Inflammatory and Immune System 258161 258161 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Efficacy of 8g Flucloxacillin administered continuously via infusion over 24 hours
Intervention code [1] 257043 0
Treatment: Drugs
Comparator / control treatment
Four six hourly intravenous 2g boluses of Flucloxacillin over 24 hours
Control group
Active

Outcomes
Primary outcome [1] 259019 0
Nursing time in preparing and administering drug measured with a stopwatch by an independent observer
Timepoint [1] 259019 0
First 24 hours of treatment
Primary outcome [2] 259020 0
Patient and Nurse satisfaction as measured by a written questionnaire
Timepoint [2] 259020 0
At 24 hours
Secondary outcome [1] 265255 0
Proportion of patients discharged on oral antibiotics at 24 hours as documented in the patient record.
Timepoint [1] 265255 0
24 hours after admission
Secondary outcome [2] 265256 0
Serum flucloxacillin levels
Timepoint [2] 265256 0
16 hours after first antibiotic dose

Eligibility
Key inclusion criteria
Patients with cellulitis felt to be clinically suitable for management in an Emergency Department Short Stay Unit.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Abbreviated Mortality in Emergency Department Sepsis Score >4
Physician intends to treat with other than Flucloxacillin 2G Intravenously four times daily
Patient has any of the following comorbidities:
*Diabetes Mellitus
*Chronic Systemic Steroid Use
*Immunosuppression
Patient will not be contactable by telephone for next 31 days

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/10/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3142 0
4029

Funding & Sponsors
Funding source category [1] 257487 0
Government body
Name [1] 257487 0
Queensland Emergency Medicine Research Foundation
Country [1] 257487 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane & Women's Hospital
Address
Butterfield Street,
Herston
Qld 4029
Country
Australia
Secondary sponsor category [1] 256724 0
None
Name [1] 256724 0
Address [1] 256724 0
Country [1] 256724 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259515 0
Royal Brisbane & Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 259515 0
Royal Brisbane & Women's Hospital
Butterfield Street
Herston
QLD 4029
Ethics committee country [1] 259515 0
Australia
Date submitted for ethics approval [1] 259515 0
19/04/2010
Approval date [1] 259515 0
27/07/2010
Ethics approval number [1] 259515 0
HREC/10/QRBW/137

Summary
Brief summary
The purpose of this study is to test the hypothesis that by managing Emergency Department patients with uncomplicated cellulitis in a short stay unit with a continuous 24 hour infusion of 8g of intravenous flucloxacillin as opposed to the current standard treatment of four 2g intravenous blouses administered every six hours for 24 hours, significant nursing time and resources would be saved with there being no decrease in the clinical or microbiological cure rate of the cellulitis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31541 0
Address 31541 0
Country 31541 0
Phone 31541 0
Fax 31541 0
Email 31541 0
Contact person for public queries
Name 14788 0
Dr Peter Logan
Address 14788 0
Department of Emergency Medicine
Royal Brisbane & Women's Hospital
Butterfield Street
Herston
Qld 4029
Country 14788 0
Australia
Phone 14788 0
+61736368111
Fax 14788 0
Email 14788 0
[email protected]
Contact person for scientific queries
Name 5716 0
Dr Peter Logan
Address 5716 0
Department of Emergency Medicine
Royal Brisbane & Women's Hospital
Butterfield Street
Herston
Qld 4029
Country 5716 0
Australia
Phone 5716 0
+61736368111
Fax 5716 0
Email 5716 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.