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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.
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Scientific title
A randomised controlled trial of oral antibiotics compared with intravenous antibiotics for the treatment of cellulitis.
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Secondary ID [1]
259706
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cellulitis
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Studies of infection and infectious agents
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Condition category
Condition code
Skin
259429
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0
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Other skin conditions
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Infection
259436
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0
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Studies of infection and infectious agents
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Intervention/exposure
Study type
Interventional
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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..
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Intervention code [1]
264134
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Treatment: Drugs
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Lack of progression of Erythema; measured as the maximum diameter of erythema in cms.
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Assessment method [1]
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Timepoint [1]
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Day 1,2, 3, 7 and 28
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Primary outcome [2]
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The primary outcome measure was days until no advancement of the area of cellulitis.
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Assessment method [2]
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Timepoint [2]
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Days until no advancement in cellulitis (measured daily until advancement ceased)
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Secondary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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Day 3, 7 and 28 after commencement of treatment
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Eligibility
Key inclusion criteria
Referral from Emergency Department Staff for treatment of cellulitis with intravenous antibiotics as an inpatient or outpatient.
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Minimum age
16
Years
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Maximum age
100
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Blinded treatment allocation using a computer assisted randomisation program.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation generated by computer software package
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Safety/efficacy
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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.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/03/2011
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Actual
19/03/2011
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Date of last participant enrolment
Anticipated
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Actual
23/04/2013
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
56
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment postcode(s) [1]
8469
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3076 - Epping
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Northern Health
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Address [1]
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185 Cooper St, Epping Vic 3076
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Country [1]
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Australia
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Primary sponsor type
Hospital
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Name
Northern Health
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Address
185 Cooper St, Epping Vic 3076
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
263729
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Northern Health Human Research Ethics Committee
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Ethics committee address [1]
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Northern Health
185 Cooper St, Epping, 3076 Victoria
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
260582
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Approval date [1]
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31/12/2010
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Ethics approval number [1]
260582
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A43/10
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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.
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Trial website
Not Applicable
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof A/Prof Craig Aboltins
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Address
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Department Infectious Diseases
Clinical Medicine
Northern Health
185 Cooper St
Epping
Victoria 3076
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Country
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Australia
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Phone
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+ 61 3 8405 2052
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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A/Prof Dr Craig Aboltins
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Address
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Dept of Medicine
Northern Health
185 Cooper St, Epping
Victoria 3076
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Country
15538
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Australia
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Phone
15538
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+ 61 3 8405 2052
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Fax
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+61 3 8405 8683
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Email
15538
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[email protected]
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Contact person for scientific queries
Name
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A/Prof Dr Craig Aboltins
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Address
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Dept of Medicine
Northern Health
185 Cooper St, Epping
Victoria 3076
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Country
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Australia
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Phone
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+ 61 3 8405 2007
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Fax
6466
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+61 3 8405 8683
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Email
6466
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[email protected]
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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
Source
Title
Year of Publication
DOI
Embase
Oral versus parenteral antimicrobials for the treatment of cellulitis: A randomized non-inferiority trial.
2015
https://dx.doi.org/10.1093/jac/dku397
N.B. These documents automatically identified may not have been verified by the study sponsor.
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