Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000996662
Ethics application status
Not yet submitted
Date submitted
6/09/2014
Date registered
16/09/2014
Date last updated
16/09/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot randomised clinical trial: flucloxacillin plus probenecid versus flucloxacillin alone for uncomplicated skin infections
Scientific title
Skin infection treatment with flucloxacillin and probenecid versus flucloxacillin: a pilot randomised clinical trial
Secondary ID [1] 285297 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skin infection 292966 0
Cellulitis 293042 0
Abscess 293043 0
infected wound 293044 0
Condition category
Condition code
Infection 293261 293261 0 0
Other infectious diseases
Skin 293262 293262 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Flucloxacillin 1 g twice daily orally plus probenecid 500 mg twice daily orally for 7 days
Adherence will be monitored by tablet count in blister pack
Intervention code [1] 290200 0
Treatment: Drugs
Comparator / control treatment
Flucloxacillin 500 mg four times daily orally for 7 days. Adherence will be monitored by capsule count in blister pack
Control group
Active

Outcomes
Primary outcome [1] 293111 0
Complete resolution, improvement, no change or worsening in infection surface area, redness, swelling, pain, tenderness and purulence, and in feverishness. Surface area will be measured by FDA-recommended width x length method. Redness, swelling and purulence will be assessed by the research assistant. Pain, tenderness and feverishness will be assessed by visual analogue scale
Timepoint [1] 293111 0
At 48-72 hr after starting treatment, 7 to 8 days after starting treatment, and 7 to 14 days after completing treatment
Secondary outcome [1] 310357 0
The presence (or not) of any treatment-associated adverse effects, including stomach upset, vomiting, diarrhoea, headache, dizziness, rash, itch, flushing, or joint pain. The patient may also free-text any other possible TAAE.
Timepoint [1] 310357 0
At48-72 hr after starting treatment, 7 to 8 days after starting treatment and 7 to 14 days after completing treatment
Secondary outcome [2] 310358 0
Mortality
Timepoint [2] 310358 0
28 days

Eligibility
Key inclusion criteria
New onset skin infection - cellulitis, abscess, wound infection
Area of the infection should be at least 75 cm2 (lesion size measured by the area of redness, oedema or induration)Weight less than 120 kg
Outpatient
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Infected animal or human bites
Necrotising infections
Diabetic foot infections or infection complicating severe peripheral vascular disease
Decubitus ulcer infection
Infection associated with a vascular, enteric or urinary catheter site
Infection associated with underlying thrombophlebitis, osteomyelitis, septic arthritis or sepsis syndrome
Infection associated with a wound from surgery that was not clean surgery
Infection associated with marine or freshwater injury
Facial cellulitis
Gram-negative pathogen suspected or documented; MRSA suspected or documented
Severe immunocompromise (e.g., neutropenia)
Previous treatment failure at the same infection site – more than 24 hours therapy with an oral or parenteral antibiotic
Topical or other systemic antibiotic with gram-positive activity within 96 hours of first dose of study drug
Contra-indications to study medications:
Pregnancy or breastfeeding
Allergy to probenecid or any penicillin; severe allergy to a cephalosporin
Renal impairment (GFR < 40)
Past kidney stones
Recent or current gout
Liver disease

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)
A GP or ED doctor refers the patient. If consents, randomise to one of two parallel arms. Randomise for each of three main infection types. Allocation concealment by sealed opaque envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by computerised sequence generation, stratified by type of infection
Masking / blinding
Open (masking not 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
Not yet recruiting
Date of first participant enrolment
Anticipated
3/11/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 6341 0
New Zealand
State/province [1] 6341 0
Nelson/Tasman

Funding & Sponsors
Funding source category [1] 289916 0
Charities/Societies/Foundations
Name [1] 289916 0
Nelson Medical Research and Education Trust
Country [1] 289916 0
New Zealand
Primary sponsor type
Other
Name
Nelson Bays Primary Health
Address
PO Box 1776
Nelson 7040
Country
New Zealand
Secondary sponsor category [1] 288607 0
Government body
Name [1] 288607 0
Nelson Marlborough District Health Board
Address [1] 288607 0
Private Bag 18
Nelson 7010
Country [1] 288607 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 291635 0
New Zealand Health and Disability Ethics Committee
Ethics committee address [1] 291635 0
Ethics committee country [1] 291635 0
New Zealand
Date submitted for ethics approval [1] 291635 0
20/09/2014
Approval date [1] 291635 0
Ethics approval number [1] 291635 0

Summary
Brief summary
Pharmacokinetic studies show that probenecid more than doubles the T>MIC90 for flucloxacillin and S. aureus and unpublished case series support the use of probenecid in this manner. We wish to formally compare probenecid-boosted oral flucloxacillin with flucloxacillin alone in adults with mild to moderate outpatient skin infections
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51274 0
Dr Richard Everts
Address 51274 0
Nelson Bays Primary Health
PO Box 1776
Nelson 7040
Country 51274 0
New Zealand
Phone 51274 0
+64 274633284
Fax 51274 0
+64 3 5394958
Email 51274 0
richard.everts@nbph.org.nz
Contact person for public queries
Name 51275 0
Dr Richard Everts
Address 51275 0
Nelson Bays Primary Health
PO Box 1776
Nelson 7040
Country 51275 0
New Zealand
Phone 51275 0
+64 274633284
Fax 51275 0
+64 3 5394958
Email 51275 0
richard.everts@nbph.org.nz
Contact person for scientific queries
Name 51276 0
Dr Richard Everts
Address 51276 0
Nelson Bays Primary Health
PO Box 1776
Nelson 7040
Country 51276 0
New Zealand
Phone 51276 0
+64 274633284
Fax 51276 0
+64 3 5394958
Email 51276 0
richard.everts@nbph.org.nz

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
No additional documents have been identified.