Trial Review

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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] 296541 0
None
Universal Trial Number (UTN)
U1111-1223-3820
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cellulitis 310324 0
Condition category
Condition code
Infection 309055 309055 0 0
Other infectious diseases
Skin 309069 309069 0 0
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] 312847 0
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] 308018 0
Number of patients discharged home as recorded on enrolment data collection sheets by treating clinician
Timepoint [1] 308018 0
At any point in the first 24 hours
Secondary outcome [1] 353657 0
Composite outcome of readmission or re-occurrence as recorded in follow up telephone interviews or hospital records
Timepoint [1] 353657 0
7 days post discharge
Secondary outcome [2] 353658 0
Patient satisfaction via study specific questionnaire
Timepoint [2] 353658 0
7 days post discharge
Secondary outcome [3] 353659 0
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] 353659 0
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?
No
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)
NT
Recruitment hospital [1] 12371 0
Royal Darwin Hospital - Tiwi
Recruitment postcode(s) [1] 24634 0
0810 - Tiwi

Funding & Sponsors
Funding source category [1] 301121 0
Hospital
Name [1] 301121 0
Royal Darwin Hospital
Country [1] 301121 0
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] 300739 0
None
Name [1] 300739 0
Address [1] 300739 0
Country [1] 300739 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 301873 0
TEHS HREC
Ethics committee address [1] 301873 0
John Mathews Building (JMB)
Building 58, Royal Darwin Hospital Campus
105 Rocklands Dr
Tiwi NT 0810
Ethics committee country [1] 301873 0
Australia
Date submitted for ethics approval [1] 301873 0
07/12/2018
Approval date [1] 301873 0
Ethics approval number [1] 301873 0

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 88390 0
Dr Ashley Loughman
Address 88390 0
Careflight NT
Darwin International Airport
12 Lancaster Rd
Eaton NT 0820
Country 88390 0
Australia
Phone 88390 0
61423535547
Fax 88390 0
Email 88390 0
[email protected]
Contact person for public queries
Name 88391 0
Dr Ashley Loughman
Address 88391 0
Careflight NT
Darwin International Airport
12 Lancaster Rd
Eaton NT 0820
Country 88391 0
Australia
Phone 88391 0
61423535547
Fax 88391 0
Email 88391 0
[email protected]
Contact person for scientific queries
Name 88392 0
Dr Ashley Loughman
Address 88392 0
Careflight NT
Darwin International Airport
12 Lancaster Rd
Eaton NT 0820
Country 88392 0
Australia
Phone 88392 0
61423535547
Fax 88392 0
Email 88392 0
[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.TypeCitationLinkEmailOther DetailsAttachment
162Study 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.