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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03632642




Registration number
NCT03632642
Ethics application status
Date submitted
22/07/2018
Date registered
15/08/2018

Titles & IDs
Public title
Penicillin Against Flucloxacillin Treatment Evaluation
Scientific title
Pilot Randomised Controlled Trial of Penicillin Versus Flucloxacillin for Definitive Treatment of Invasive Penicillin Susceptible Staphylococcus Aureus
Secondary ID [1] 0 0
HREC/17/QRBW/620
Universal Trial Number (UTN)
Trial acronym
PANFLUTE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Staphylococcus Aureus 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Benzylpenicillin
Treatment: Drugs - Flucloxacillin

Active comparator: Benzylpenicillin arm - Patients randomised to benzylpenicillin will be treated according to Therapeutic Guidelines 15th Edition. During hospitalisation, the standard dose will be 1.8g Q4H IVI for uncomplicated BSIs and 2.4g Q4H for deep-seated or critical illness infections.

Active comparator: Flucloxacillin arm - Patients randomised to flucloxacillin will be treated according to Therapeutic Guidelines 15th Edition. During hospitalisation, the standard dose will be 2g Q6H IVI or 2g Q4H for deep-seated or criticial illness infections.


Treatment: Drugs: Benzylpenicillin
The study drug will be administered for a minimum of 2 weeks (the minimal currently accepted duration of IV therapy for SAB.) For patients who do not fulfill criteria for 2 weeks of therapy, the duration of treatment will be 4 to 6 weeks and will be made by the treating clinician.

Treatment: Drugs: Flucloxacillin
The study drug will be administered for a minimum of 2 weeks (the minimal currently accepted duration of IV therapy for SAB.) For patients who do not fulfill criteria for 2 weeks of therapy, the duration of treatment will be 4 to 6 weeks and will be made by the treating clinician.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Feasibility of DOOR
Timepoint [1] 0 0
90 day
Secondary outcome [1] 0 0
Adverse Events
Timepoint [1] 0 0
90 day
Secondary outcome [2] 0 0
Mortality
Timepoint [2] 0 0
14, 42 and 90 days
Secondary outcome [3] 0 0
Time to defervescence
Timepoint [3] 0 0
From randomisation to any period where a temperature is < 37.5 degrees celsius for greater than or equal to 24 hours
Secondary outcome [4] 0 0
Persistent bacteraemia
Timepoint [4] 0 0
Day 3 and day 7
Secondary outcome [5] 0 0
Microbiologic relapse
Timepoint [5] 0 0
Any period within 90 days from randomisation following a negative blood culture at least 3 days prior
Secondary outcome [6] 0 0
Microbiologic treatment failure
Timepoint [6] 0 0
Any period within day 14 to day 90 from randomisation
Secondary outcome [7] 0 0
Healthcare costs
Timepoint [7] 0 0
90 day

Eligibility
Key inclusion criteria
* Bloodstream infection with Staphylococcus aureus susceptible to penicillin and negative for penicillinase by phenotypic methods.
* No more than 72 hours has elapsed since the first positive blood culture was drawn
* Patient is aged 18 years and over
* The patient or approved proxy is able to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patient with a recorded allergy to penicillin including:

1. Hypersensitivity type reaction
2. Stephens-Johnson syndrome
3. Rash
4. Urticaria
* Contraindications based upon other recorded allergies, such as gastrointestinal upset, will be at the discretion of the treating clinician
* Patient with significant polymicrobial bacteraemia (skin contaminants excepted)
* Treated with non-curative intent
* Pregnancy or breast-feeding
* Patient currently receiving concomitant antimicrobials with activity against S. aureus which cannot be ceased or substituted.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/07/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2020
Actual
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Brisbane Private Hospital - Brisbane
Recruitment postcode(s) [1] 0 0
4000 - Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Paterson
Address 0 0
UQCCR
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
As this study is a feasibility pilot study of a planned definitive RCT, it is likely that IPD will be made available to future potential collaborators on a definitive study in order to determine the feasibility, calculate an appropriate sample size and determine if any changes are required to the study protocol and SAP in particular.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03632642