ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618001840279p

Ethics application status

Not yet submitted

Date submitted

7/11/2018

Date registered

12/11/2018

Date last updated

12/11/2018

Date data sharing statement initially provided

12/11/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

Is Oral or Intravenous administration of antibiotics superior in the treatment of moderate cellulitis?

Scientific title

Superiority of Oral or Intravenous administration of antibiotics in the treatment of moderate cellulitis, a randomised control trial.

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1223-3820

Trial acronym

Linked study record

Health condition

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

Cellulitis

Condition category

Condition code

Infection

Other infectious diseases

Skin

Other skin conditions

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Oral Antibiotics, 1g Flucloxacillin four times daily or 450mg Clindamycin three times daily in case of penicillin immediate type hypersensitivity. Therapies will be directly administered as inpatient treatment with administration recorded in medication charts.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Intravenous antibiotics, 1g Flucloxacillin four times daily or 450mg Clindamycin three times daily in case of penicillin immediate type hypersensitivity. Therapies will be directly administered as inpatient treatment with administration recorded in medication charts.

Control group

Active

Outcomes

Primary outcome [1]

Number of patients discharged home as recorded on enrolment data collection sheets by treating clinician

Timepoint [1]

At any point in the first 24 hours

Secondary outcome [1]

Composite outcome of readmission or re-occurrence as recorded in follow up telephone interviews or hospital records

Timepoint [1]

7 days post discharge

Secondary outcome [2]

Patient satisfaction via study specific questionnaire

Timepoint [2]

7 days post discharge

Secondary outcome [3]

Complications of treatment(Intravenous cannula site infections, antibiotic associated diarrhoea, allergic and anaphylactic reactions) as recorded in follow up telephone interviews or hospital records

Timepoint [3]

7 days post discharge

Eligibility

Key inclusion criteria

Presence of Cellulitis as defined by the presence of acute dermal/epidermal inflammation lasting <5 days and of probable infective aetiology. At least one marker of moderate severity, either a marker of systemic inflammatory response (documented temperature >37.8c, tachycardia >90bpm, systemic symptoms inc. malaise, flu like symptoms, nausea and vomiting or elevated inflammatory markers) or a risk factor eg. Diabetes, homelessness, etc.

Minimum age

16 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Patients will be excluded if they are unable to or decline consent; have mild cellulitis suitable for immediate discharge(limited area <10cm in longest axis, no risk factors, no systemic symptoms); cellulitis complicating trauma, intravenous drug use or recent (<30 days) surgical sites; periorbital cellulitis; immunosuppressed patients; morbidly obese patients; a diagnosis other than cellulitis or complicated cellulitis (severe sepsis, extensive bullous changes, abscess formation or suspected necrotising deep tissue involvement); vomiting precluding oral therapy or prior treatment with per protocol oral antimicrobials for >48 hours or parenteral antimicrobials

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)

sealed envelope in a 1:1 ratio with a 10 block schedule

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Permuted block randomisation

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Two-tailed T tests will be performed with a p value of 0.05 indicating significance.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/01/2019

Actual

Date of last participant enrolment

Anticipated

1/01/2020

Actual

Date of last data collection

Anticipated

1/02/2020

Actual

Sample size

Target

412

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Royal Darwin Hospital - Tiwi

Recruitment postcode(s) [1]

0810 - Tiwi

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Royal Darwin Hospital

Address [1]

105 Rocklands Dr
Tiwi NT 0810

Country [1]

Australia

Primary sponsor type

Individual

Name

Ashley Loughman

Address

Careflight NT
Darwin International Airport
12 Lancaster Rd
Eaton NT 0820

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

TEHS HREC

Ethics committee address [1]

John Mathews Building (JMB)
Building 58, Royal Darwin Hospital Campus
105 Rocklands Dr
Tiwi NT 0810

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

07/12/2018

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

Cellulitis, a spreading skin infection treated with antibitoics, is routinely stratified according to severity and patient risk factors. Moderate-severity cellulitis is commonly treated with short-course intravenous antibitoics followed by oral antibiotics. This is some evidence to suggest moderate-severity cellulitis could be safely treated with oral antibiotics. 
This prospective, single-blinded trial will assess the efficacy and safety of oral antibiotics for the treatment of moderate-severity cellulitis. Participants will be randomized to treatment with either oral or intravenous antibiotics and assessed for rates of treatment success and complications.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Ashley Loughman

Address

Careflight NT
Darwin International Airport
12 Lancaster Rd
Eaton NT 0820

Country

Australia

Phone

61423535547

Fax

[email protected]

Contact person for public queries

Name

Ashley Loughman

Address

Careflight NT
Darwin International Airport
12 Lancaster Rd
Eaton NT 0820

Country

Australia

Phone

61423535547

Fax

[email protected]

Contact person for scientific queries

Name

Ashley Loughman

Address

Careflight NT
Darwin International Airport
12 Lancaster Rd
Eaton NT 0820

Country

Australia

Phone

61423535547

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Undecided

No/undecided IPD sharing reason/comment

As yet undecided

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
162	Study protocol					376333-(Uploaded-07-11-2018-12-06-05)-Study-related document.docx

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.

Trial Review

Documents added manually

Documents added automatically