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Trial registered on ANZCTR


Registration number
ACTRN12611000685910
Ethics application status
Approved
Date submitted
1/03/2011
Date registered
6/07/2011
Date last updated
25/07/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial of oral antibiotics compared with intravenous antibiotics for the treatment of cellulitis.
Scientific title
A randomised controlled trial of oral antibiotics compared with intravenous antibiotics for the treatment of cellulitis.
Secondary ID [1] 259706 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cellulitis 261280 0
Studies of infection and infectious agents 261289 0
Condition category
Condition code
Skin 259429 259429 0 0
Other skin conditions
Infection 259436 259436 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
intervention(s) / exposure* Intravenous Antibiotics
Cefazolin 2g intravenously 12 hourly or if immediate penicillin hypersensitivity exists, Clindamycin 450mg iv eight hourly.

2-3 days of Intravenous antibiotics or until progression of erythema stops then followed by oral for total treatment duration of 10 days. Oral Treatment: Cephalexin 1g orally every six hours or if immediate penicillin hypersensitivity exists, Clindamycin 450mg every eight hours to complete a total of 10 days of antibiotic treatment..
Intervention code [1] 264134 0
Treatment: Drugs
Comparator / control treatment
oral antibiotics
Cephalexin 1g orally every six hours or if immediate penicillin hypersensitivity exists, Clindamycin 450mg every eight hours for 10 days.
Control group
Active

Outcomes
Primary outcome [1] 262237 0
Lack of progression of Erythema; measured as the maximum diameter of erythema in cms.
Timepoint [1] 262237 0
Day 1,2, 3, 7 and 28
Primary outcome [2] 292754 0
The primary outcome measure was days until no advancement of the area of cellulitis.
Timepoint [2] 292754 0
Days until no advancement in cellulitis (measured daily until advancement ceased)
Secondary outcome [1] 273367 0
Rate of Complications from Cellulitis or Treatments.

Failure to respond to treatment, progression of erythema and /or development of signs and symptoms of systemic infection.
Requirement for escalation of treatment.
Requirement for readmission for management of cellulitis.
Timepoint [1] 273367 0
Day 3, 7 and 28 after commencement of treatment

Eligibility
Key inclusion criteria
Referral from Emergency Department Staff for treatment of cellulitis with intravenous antibiotics as an inpatient or outpatient.
Minimum age
16 Years
Maximum age
100 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) Necrotising fasciitis is suspected (suggested by involvement of subcutaneous tissues with subcutaneous induration, severe necrosis or gas, severe pain, rapid progression, severe sepsis, ongoing rigors, perineal or abdominal location)
b) Complicated cellulitis (hypotension or other signs of severe sepsis, bullous skin changes, abscess formation).
c) Cellulitis complicating trauma, especially penetrating injury (may need surgical debridement).
d) Site: periorbital cellulitis, perineal cellulitis.
e) Patient: Children (age < 16 years), Immunosuppressed patients
f) Vomiting or any other reason precluding oral antibiotic therapy.
g) Treatment with oral antibiotics for greater than 48 prior to referral or with intravenous antibiotics for greater than 12 hours before referral.

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)
Blinded treatment allocation using a computer assisted randomisation program.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation generated by computer software package
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
The trial was designed to assess non-inferiority of the oral arm when compared to the parenteral arm. Based on clinician researcher opinion of acceptable clinical difference, a non-inferiority margin of 15% was used for the primary outcome. Specifically, the oral arm was considered non-inferior if the upper limit of the 95% confidence interval for the difference in means was less than +15% of the mean value for the parenteral arm.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 8469 0
3076 - Epping

Funding & Sponsors
Funding source category [1] 264589 0
Hospital
Name [1] 264589 0
Northern Health
Address [1] 264589 0
185 Cooper St, Epping Vic 3076
Country [1] 264589 0
Australia
Primary sponsor type
Hospital
Name
Northern Health
Address
185 Cooper St, Epping Vic 3076
Country
Australia
Secondary sponsor category [1] 263729 0
None
Name [1] 263729 0
Address [1] 263729 0
Country [1] 263729 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260582 0
Northern Health Human Research Ethics Committee
Ethics committee address [1] 260582 0
Northern Health
185 Cooper St, Epping, 3076 Victoria
Ethics committee country [1] 260582 0
Australia
Date submitted for ethics approval [1] 260582 0
Approval date [1] 260582 0
31/12/2010
Ethics approval number [1] 260582 0
A43/10

Summary
Brief summary
Cellulitis is an acute spreading infection of the skin. It develops as a result of entry of bacteria, especially beta-haemolytic Streptococci spp. and Staphylococcus aureus, through the skin barrier. It is a common condition that is often thought by health professionals to require treatment with intravenous antibiotics initially, resulting a high rate of presentation and admission to acute medical services. To reduce the burden on hospital inpatient beds, intravenous antibiotics have increasingly been administered at home by visiting nursing services or Hospital In The Home (HITH) programs to treat cellulitis. Intravenous antibiotics have the associated problems of local intravenous line site complications including phlebitis and infection as well as the costs of nursing and medical staff required to administer the antibiotics. With these problems in mind, clinicians at the The Northern Hospital (TNH) have developed clinical experience successfully using oral antibiotics for many patients with cellulitis referred for treatment with intravenous antibiotics. Limited evidence exists supporting this approach in patients with cellulitis. Oral penicillin has been shown to be equivalent to initial intravenous then oral penicillin in inpatients admitted with the diagnosis of cellulitis. Similarly oral pristinomycin has been shown to be non-inferior to an intravenous then oral penicillin regimen for inpatients with cellulitis. Neither of these studies investigated patients treated by HITH programs nor did they use antibiotics regimens that would commonly be prescribed in Australia for this indication. There is more recent and substantial evidence showing success in favouring early oral antibiotics in patients with community-acquired pneumonia another common infection that was previously thought to require intravenous antibiotics in many cases presenting to hospital.

Justification for project

Any research that demonstrated that treatment of cellulitis with oral antibiotics was as effective as treatment with intravenous antibiotics would have important implications in that patients may be able to be treated more safely and with less expense. Comparison with patients treated in HITH settings and in Australia with antibiotics commonly used here would have particular relevance. If information gained from this trial is useful then this may be used to justify a larger multi-centre trial to more definitively inform guidelines in the area.
Trial website
Not Applicable
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32291 0
A/Prof A/Prof Craig Aboltins
Address 32291 0
Department Infectious Diseases
Clinical Medicine
Northern Health
185 Cooper St
Epping
Victoria 3076
Country 32291 0
Australia
Phone 32291 0
+ 61 3 8405 2052
Fax 32291 0
Email 32291 0
craig.aboltins@nh.org.au
Contact person for public queries
Name 15538 0
A/Prof Dr Craig Aboltins
Address 15538 0
Dept of Medicine
Northern Health
185 Cooper St, Epping
Victoria 3076
Country 15538 0
Australia
Phone 15538 0
+ 61 3 8405 2052
Fax 15538 0
+61 3 8405 8683
Email 15538 0
Craig.Aboltins@nh.org.au
Contact person for scientific queries
Name 6466 0
A/Prof Dr Craig Aboltins
Address 6466 0
Dept of Medicine
Northern Health
185 Cooper St, Epping
Victoria 3076
Country 6466 0
Australia
Phone 6466 0
+ 61 3 8405 2007
Fax 6466 0
+61 3 8405 8683
Email 6466 0
Craig.Aboltins@nh.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary