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Trial registered on ANZCTR


Registration number
ACTRN12611000515998
Ethics application status
Approved
Date submitted
13/05/2011
Date registered
18/05/2011
Date last updated
10/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised trial of ibuprofen in addition to usual care for cellulitis of the lower limb.
Scientific title
In adults with uncomplicated lower limb cellulitis, does the addition of ibuprofen 400mg three times per day orally for five days to usual antibiotic treatment, compared with an identical placebo, lead to more rapid resolution of inflammation?
Secondary ID [1] 262163 0
Nil
Universal Trial Number (UTN)
U1111-1121-3569
Trial acronym
CHARIOT - Cellulitis: HAstening Resolution with IbuprOfen Therapy.
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Uncomplicated cellulitis of the lower limb 265849 0
Condition category
Condition code
Infection 266003 266003 0 0
Other infectious diseases
Skin 266038 266038 0 0
Other skin conditions
Inflammatory and Immune System 266039 266039 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ibuprofen tablets (Herron blue brand 200mg tablets) 400mg three times per day orally for five days, in addition to usual antibiotic therapy (Cephazolin 2 grams twice per day intravenously until clinically improved, then oral antibitoics as prescribed by the treating clinicians)
Intervention code [1] 264575 0
Treatment: Drugs
Comparator / control treatment
Placebo two tablets three times per day orally for five days in addition to usual antibiotic therapy (Cephazolin 2 grams twice per day intravenously until clinically improved, then oral antibitoics as prescribed by the treating clinicians)
Control group
Placebo

Outcomes
Primary outcome [1] 266752 0
Proportion of patients with regression of inflammation, defined as the superior edge of inflammation moving inferiorly rather than advancing or staying static. Assessed twice daily by treating nurse, using a pen marker to mark the leading edge, as well as a photograph for independant confirmation by a physician.
Timepoint [1] 266752 0
48 hours after the first effective dose of intravenous antibiotic.
Secondary outcome [1] 276307 0
Duration of intravenous antibiotic treatment
Timepoint [1] 276307 0
For the current episode of cellulitis
Secondary outcome [2] 276308 0
Time to return to normal leg function, defined as being able to walk at least 10 metres without a walking aid or assistance.
Timepoint [2] 276308 0
For the current episode of cellulitis
Secondary outcome [3] 276309 0
Proportion with serum creatinine>120 micromoles/litre
Timepoint [3] 276309 0
On day 6 of the study (5 days post-randomisation)

Eligibility
Key inclusion criteria
1) Age >=18 years.
2) Uncomplicated lower limb cellulitis or erysipelas.

Cellulitis/erysipelas are defined as being present if the diagnosis has been made by an Infectious Diseases registrar or consultant.

The following will be considered “complicated” and will thus not be eligible: Abscess requiring surgical intervention. Post-operative wound infection. Coexisting deep venous thrombosis. Suspected or proven necrotising fasciitis or gas gangrene. Cellulitis extending superior to the inguinal ligament.

3) Admitted directly to the Hospital in the Home unit from the emergency department or a referring GP.

4) Receiving intravaneous Cefazolin 2grams every 12 hours

5) Able to be randomised within 24 hours of the first dose of effective IV antibiotics.
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Allergy to non-steroidal anti-inflammatory drugs including aspirin.
2) Definite history of current peptic ulcer or past complicated peptic ulcer.
3) Acute renal impairment (Serum Creatinine>120).
4) Chronic renal impairment with eGFR<50.
5) Current Varicella or zoster infection (chicken pox or shingles).
6) Iatrogenic immunosuppression.
7) Known pregnancy.
8) Currently taking regular anti-inflammatory drugs that cannot be ceased
9) Currently taking therapeutic anticoagulation or potent antiplatelet agents

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)
Once a patient has been determined to meet all the eligibility criteria and has provided written informed consent, they will be allocated the next available sequential study number, and will be allocated the study drug bottle number corresponding to this. The bottles will contain either ibuprofen or placebo but the treatment allocaiton will not be listed on the bottle, nor will it be accessible to any of the clinical investiagtors.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation sequence generated by an independant statistician using permuted blocks of variable block size, with no stratification.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,NT

Funding & Sponsors
Funding source category [1] 265076 0
Government body
Name [1] 265076 0
Northern Territory Research and Innovation Board and Fund
Address [1] 265076 0
Ground Floor
Development House
76 The Esplanade
Darwin NT 0800
Country [1] 265076 0
Australia
Primary sponsor type
Individual
Name
Dr Josh Davis
Address
C/- Menzies School of Health Research
Rocklands Drive
Tiwi
NT
0811
Country
Australia
Secondary sponsor category [1] 264166 0
Hospital
Name [1] 264166 0
Royal Darwin Hospital
Address [1] 264166 0
Rocklands Drive
Tiwi
NT
0811
Country [1] 264166 0
Australia
Other collaborator category [1] 277167 0
Hospital
Name [1] 277167 0
Shoalhaven Hospital.
Address [1] 277167 0
Nowra, NSW
Country [1] 277167 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 267056 0
Human Research Ethics Committee of the Menzies School of Health Research and the Northern Territory Department of Health
Ethics committee address [1] 267056 0
C/- Menzies School of Health Research
Rocklands Drive
Tiwi
NT
0811
Ethics committee country [1] 267056 0
Australia
Date submitted for ethics approval [1] 267056 0
26/02/2011
Approval date [1] 267056 0
22/03/2011
Ethics approval number [1] 267056 0
1/11/1510

Summary
Brief summary
Cellulitis is a common, painful and disabling condition where bacterial infection spreads under the skin to cause a red, hot swollen leg. The current standard treatment of cellulitis is antibiotics to kill the responsible bacteria. This treatment is usually successful, however, most people require antibtiotic treatment, rest and time off work for 10-14 days.

A single unblinded small RCT of ibuprofen as adjunctive therapy has previously shown that patients receiving ibuprofen had substantially more rapid regression of cellulitis than those receiving antibiotics alone, with no increase in adverse effects.

We plan to conduct a pilot double-blinded randomised controlled trial of adjunctive ibuprofen versus placebo in patients with uncomplicated lower limb cellulitis to determine if this strategy leads to more rapid resolution of inflammation than standard therapy alone.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 32604 0
A/Prof Joshua Davis
Address 32604 0
c/- Menzies School of Health Research
Rocklands Drive, Tiwi
NT 0811
Australia
Country 32604 0
Australia
Phone 32604 0
+61 8 89 468464
Fax 32604 0
Email 32604 0
Joshua.Davis@menzies.edu.au
Contact person for public queries
Name 15851 0
A/Prof Dr Josh Davis
Address 15851 0
C/- Menzies School of Health Research
Rocklands Drive
Tiwi NT
0811
Country 15851 0
Australia
Phone 15851 0
+61 8 89228196
Fax 15851 0
Email 15851 0
Joshua.Davis@menzies.edu.au
Contact person for scientific queries
Name 6779 0
A/Prof Dr Josh Davis
Address 6779 0
C/- Menzies School of Health Research
Rocklands Drive
Tiwi NT
0811
Country 6779 0
Australia
Phone 6779 0
+61 8 89228196
Fax 6779 0
Email 6779 0
Joshua.Davis@menzies.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary