Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000888167p
Ethics application status
Submitted, not yet approved
Date submitted
5/06/2019
Date registered
26/06/2019
Date last updated
26/06/2019
Date data sharing statement initially provided
26/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Does a single dose of steroid improve the time to resolution of cellulitis (skin infection) in adults when given with standard antibiotic treatment
Scientific title
Does single dose corticosteroid at presentation improve time to resolution in clinically diagnosed cellulitis in adults: a double-blind randomised placebo-controlled study
Secondary ID [1] 298427 0
Nil known
Universal Trial Number (UTN)
U1111-1234-7920
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cellulitis 313166 0
Condition category
Condition code
Skin 311630 311630 0 0
Other skin conditions
Infection 311690 311690 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is the administration of a single 50mg dose of prednisolone alongside standard antibiotics for treatment of cellulitis (a skin infection). This will be given as an oral tablet, alongside their initial dose of antibiotics in the department - there will be no further doses of the intervention therefore adherence does not need to be monitored. The antibiotics given will follow and comply with the hospital antibiotic protocol, and dependent on their allergies - this is the standard care all patients with cellulitis will receive, regardless of whether a participant in the study. The antibiotic given is not relevant to this study, but will be recorded on a data collection sheet. As normal practice in Hervey Bay, they will be given a prescription for the remainder of their antibiotic course.
There is a suggestion from previous research that a course of prednisolone may improve time to resolution of symptoms in cellulitis, and also reduce hospital stay.
This study will try to identify if a single dose of prednisolone has an effect of cellulitis.
Participants will be identified by primary clinicians when seen in the Emergency Department. A single 50mg dose of prednisolone will be given alongside initial antibiotic dose in the Emergency Department by the primary clinician. No further doses/exposure will be given and the participant will continue standard care with antibiotic.
The participants will be given an information sheet, will have an opportunity to ask questions and informed consent to participate will be documented.
Intervention code [1] 314679 0
Treatment: Drugs
Comparator / control treatment
If randomly selected into the control group - the participant will receive a single dose of a placebo (calcium lactate 225mg) in the place of prednisolone, alongside their standard antibiotic treatment. This will be given to them whilst in the Emergency Department by their primary clinician. The calcium lactate will have little to no pharmacological or clinical effect as a single dose.
No further doses/exposure will be given and the participant will continue standard care with antibiotic.
Control group
Placebo

Outcomes
Primary outcome [1] 320323 0
Effect of single dose corticosteroid on time to resolution of symptoms of cellulitis when used alongside standard antibiotic treatment
Time to resolution of symptoms is the time in days from presentation for swelling, redness and pain to resolve as described in the questions below.
A telephone conversation protocol will be followed and is in the following format:
Date of presentation (Day 1): _________________
Day: 3 / 7 / 14

Regarding the area of cellulitis:
Has the redness resolved: YES / NO / SOMEWHAT
If resolution, when? ____________________

Has the warmth resolved: YES / NO / SOMEWHAT
If resolution, when? ____________________

What is your pain score at the present time (1-10): _______________
If resolution, when? ____________________

Has the swelling resolved: YES / NO / SOMEWHAT
If resolution, when? ____________________

Have you seen another health professional for the cellulitis since you came to ED initially? YES / NO
Have they changed the management for your cellulitis? YES / NO
If so, what have they changed? __________________________________________________________________________________

Do you have any concerns regarding this research?
__________________________________________________________________________________

If the cellulitis has not resolved:
Are you willing to participate in further telephone consultations: YES / NO
Timepoint [1] 320323 0
This will be assessed 3 and 7 days after presentation to the ED via telephone consultation. If no resolution at 7 days a further call be will made at 14 days.
Secondary outcome [1] 371251 0
Effect of single dose corticosteroid used in treatment of cellulitis on re-presentations to ED for the same infection.
Data will be collected using Emergency Department Information System (EDIS) computer medical records, as approved by Hervey Bay Data Custodian.
The data collection tool for this will be in the following format:

Has the participant re-presented to ED for the same infection by day 28? YES / NO
Timepoint [1] 371251 0
Assessed at 28 days after initial presentation to ED

Eligibility
Key inclusion criteria
- Cellulitis effecting trunk or limb
- Aged 18-75 years
- Able to give informed consent
- For treatment with antibiotics
- First presentation of acute episode
- Patients who are admitted to and discharged from the ED or admitted to Hospital in the Home (HITH)
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Below 18 years of age or above 75 years of age
- Inability to consent
- Adrenal insufficiency
- Steroid use in the last 2 weeks
- Allergy to steroids
- Admitted into hospital
- Immunocompromised
- Abnormal vital signs (HR >110, BP <100/60, respiration rate >22, O2 saturation <90%)
- Pregnancy or breast feeding
- In a correctional facility

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)
The primary clinician will identify those with cellulitis presenting to ED who fulfil the eligibility criteria.
The study will take place at Hervey Bay Emergency Department.
Placebo and steroid will be divided blindly by a person independent to the study into Group A or Group B packets and placed in a randomized order using a random number generator, and stored in the treatment room.
Participants will be consented by their primary clinician and have clerical details confirmed. They will take their randomly allocated intervention alongside regular antibiotic treatment.
Their allocation will remain concealed until after the follow up telephone consultations and will only be made available after the final participant has been checked on the hospital computer system for re-presentations to ED, which will be conducted 28 days after their presentation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Placebo and steroid will be divided blindly by a person independent to the study into Group A or Group B packets and placed in a randomized order using a computerised random number generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size: If the placebo control group on average takes 4 +/- 2 days from presentation to resolution of symptoms/signs and the steroid group is expected to take 3 +/-2 to resolution, the sample size that would produce a statistically significant result (p <0.05) would by 127 – therefore the group sizes proposed would be 65 in each group (total 130).

Data analysis:
• The study will be unblinded after the last participant has been check for re-presentations to ED
• Data will be transcribed from the data collection sheets into Microsoft Excel
• Comparative statistics e.g. mean, median, mode, range and t-test
• Software – Microsoft Excel

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/07/2019
Actual
Date of last participant enrolment
Anticipated
30/09/2019
Actual
Date of last data collection
Anticipated
28/10/2019
Actual
Sample size
Target
130
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 13945 0
Hervey Bay Hospital - Pialba
Recruitment postcode(s) [1] 26713 0
4655 - Pialba

Funding & Sponsors
Funding source category [1] 302980 0
Hospital
Name [1] 302980 0
Hervey Bay Emergency Department
Country [1] 302980 0
Australia
Primary sponsor type
Hospital
Name
Wide Bay Hospitals and Health Services
Address
Hervey Bay Hospital
Urraween Road
Hervey Bay
Queensland
4655
Country
Australia
Secondary sponsor category [1] 302935 0
None
Name [1] 302935 0
Address [1] 302935 0
Country [1] 302935 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 303530 0
The Prince Charles Hospital Human Research Ethics Committee
Ethics committee address [1] 303530 0
Research, Ethics and Governance Unit
Building 14
The Prince Charles Hospital
Rode Road, Chermside, QLD 4032
Ethics committee country [1] 303530 0
Australia
Date submitted for ethics approval [1] 303530 0
10/06/2019
Approval date [1] 303530 0
Ethics approval number [1] 303530 0

Summary
Brief summary
The use of steroids in combination with antibiotics for cellulitis may reduce symptoms, such as swelling, warmth, pain and redness for patients and time to resolution of the infection. For the Emergency Department (ED) this may mean a reduction in admissions into hospital/observation unit, the use of secondary antibiotics, and re-presentation to the ED.
The study is designed as a double-blind placebo-controlled study with the use of a single dose of 50mg prednisolone or a single dose of placebo alongside standard care of antibiotics on first presentation of cellulitis to the ED.
Measurement of time to resolution of symptoms will be obtained by telephone follow up at day 3 and 7, also at day 14 if infection has not resolved. Electronic medical records will be checked at day 28 to see if the participant re-presented to ED.
There is a suggestion from limited previous research that courses of steroids in cellulitis alongside standard care (antibiotics) have reduced hospital stays. This study will focus on patients discharged from ED with oral antibiotics. Primarily, comparisons will be made between the two groups (steroid vs placebo) to determine if there is a statistically significant difference in time to resolution and patient’s perceived symptoms. The secondary objective will be to compare rates of re-presentation to the ED
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93982 0
Dr Kate Quigley
Address 93982 0
Hervey Bay Emergency Department
Hervey Bay Hospital
Urraween Road
Hervey Bay
Queensland
4655
Country 93982 0
Australia
Phone 93982 0
+61 415573611
Fax 93982 0
Email 93982 0
[email protected]
Contact person for public queries
Name 93983 0
Dr David Johnson
Address 93983 0
Hervey Bay Emergency Department
Hervey Bay Hospital
Urraween Road
Hervey Bay
Queensland
4655
Country 93983 0
Australia
Phone 93983 0
+61 43256666
Fax 93983 0
Email 93983 0
[email protected]
Contact person for scientific queries
Name 93984 0
Dr David Johnson
Address 93984 0
Hervey Bay Emergency Department
Hervey Bay Hospital
Urraween Road
Hervey Bay
Queensland
4655
Country 93984 0
Australia
Phone 93984 0
+61 43256666
Fax 93984 0
Email 93984 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.