ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cellulitis

Studies of infection and infectious agents

Condition category

Condition code

Skin

Other skin conditions

Infection

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]

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]

Lack of progression of Erythema; measured as the maximum diameter of erythema in cms.

Timepoint [1]

Day 1,2, 3, 7 and 28

Primary outcome [2]

The primary outcome measure was days until no advancement of the area of cellulitis.

Timepoint [2]

Days until no advancement in cellulitis (measured daily until advancement ceased)

Secondary outcome [1]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/03/2011

Actual

19/03/2011

Date of last participant enrolment

Anticipated

Actual

23/04/2013

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

3076 - Epping

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Northern Health

Address [1]

185 Cooper St, Epping Vic 3076

Country [1]

Australia

Primary sponsor type

Hospital

Name

Northern Health

Address

185 Cooper St, Epping Vic 3076

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern Health Human Research Ethics Committee

Ethics committee address [1]

Northern Health
185 Cooper St, Epping, 3076 Victoria

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

31/12/2010

Ethics approval number [1]

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

A/Prof A/Prof Craig Aboltins

Address

Department Infectious Diseases
Clinical Medicine
Northern Health
185 Cooper St
Epping
Victoria 3076

Country

Australia

Phone

+ 61 3 8405 2052

Fax

craig.aboltins@nh.org.au

Contact person for public queries

Name

Dr Craig Aboltins

Address

Dept of Medicine
Northern Health
185 Cooper St, Epping
Victoria 3076

Country

Australia

Phone

+ 61 3 8405 2052

Fax

+61 3 8405 8683

Craig.Aboltins@nh.org.au

Contact person for scientific queries

Name

Dr Craig Aboltins

Address

Dept of Medicine
Northern Health
185 Cooper St, Epping
Victoria 3076

Country

Australia

Phone

+ 61 3 8405 2007

Fax

+61 3 8405 8683

Craig.Aboltins@nh.org.au

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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Documents added manually

Documents added automatically