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Trial registered on ANZCTR


Registration number
ACTRN12610000809033
Ethics application status
Approved
Date submitted
22/09/2010
Date registered
28/09/2010
Date last updated
19/08/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The use of an infection biomarker (Procalcitonin blood level) to guide antibiotic use in intensive care patients
Scientific title
The effect of a Procalcitonin guided algorithm compared with standard care on the number of antibiotic treatment days in critically ill intensive care patients with suspected infection
Secondary ID [1] 252740 0
NA
Universal Trial Number (UTN)
U1111-1117-1760
Trial acronym
(ProGUARD-ICU)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intensive care patients with presumed infection 258238 0
Condition category
Condition code
Infection 258417 258417 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be run according to a prespecified algorithm based on plasma level pf Procalcitonin:
1. if Procalcitonin level <0.1 antibiotics ceased.
2. if Procalcitonin level is rising, type of antibiotics and dosage to be changed based on clinical opinion.
3. Procalcitonin levels will be done daily up to 7 days.
Intervention code [1] 257256 0
Diagnosis / Prognosis
Intervention code [2] 257277 0
Treatment: Other
Comparator / control treatment
The Procalcitonin level will not be known in the control group. The clinician in charge, in consultation with infect disease team, will dictate the antibiotic prescribed on clinical grounds until discharge from intensive care according to antimicrobial stewardship strategies used.
Control group
Active

Outcomes
Primary outcome [1] 259267 0
The primary objective of the study is to determine if Procalcitonin (PCT) guided antibiotic therapy, compared with conventionally guided antibiotic treatment in intensive care unit patients, reduces the median number of antibiotic exposure days by 25%. This will be assessed according to number of days antibiotics are given in each arm amd recorded in drug chart.
Timepoint [1] 259267 0
This will be assessed by data linkage to medical records.
Dsicharge from intensive care (ICU) for primary outcome.
Secondary outcome [1] 265670 0
1. Total Daily Defined Dose (DDD) Antibiotic / per 1000 ICU Occupied Bed Days
Timepoint [1] 265670 0
Up to 28 days after randomisation.
Assessed by data linkage to medical records.
Secondary outcome [2] 265712 0
Emergence of new infections (Hospital acquired infections including resistant organisms post randomisation.
Timepoint [2] 265712 0
Up to discharge from hospital.
Data linkage to medical records and microbiological assay
Secondary outcome [3] 265713 0
ICU length of stay
Timepoint [3] 265713 0
up to ICU discharge
Linkage to medical records
Secondary outcome [4] 265714 0
Hospital length of stay
Timepoint [4] 265714 0
up to hospital discharge
Linkage to medical records
Secondary outcome [5] 265715 0
Ventilation time
Timepoint [5] 265715 0
up to ICU discharge
Linkage to medical records
Secondary outcome [6] 265716 0
28 day Mortality after randomisation
Timepoint [6] 265716 0
At ICU discharge, hospital discharge and 28 day.
Assessed by Linkage to medical records and phone follow up
Secondary outcome [7] 265717 0
90 days mortality from randomisation
Timepoint [7] 265717 0
Assessed at 90 days post randomisation.
Assessed by Linkage to medical records and phone follow up
Secondary outcome [8] 304207 0
Prediction of site of infection, severity of sepsis, positive vs negative culture by first PCT level recorded
Timepoint [8] 304207 0
First PCT with all microbiological isolates while in ICU
Secondary outcome [9] 304208 0
Predictive value of serial PCT and prognosis in terms of mortality
Timepoint [9] 304208 0
Decline of PCT overtime and ICU, Hospital and 90 day all-cause mortality

Eligibility
Key inclusion criteria
Patients will be eligible for inclusion in the study if they meet the following criteria;
1. Antibiotic therapy is required for presumed infection
2. Antibiotic therapy is required for > 24 hrs
3. Anticipated stay in intensive care is for > 24 hours
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Age < 18 years old
2. Antibiotics are prescribed for surgical prophylaxis only
3. Suspected or proven isolated systemic fungal infection
4. The patient is being treated with immunosuppressive agents (excluding steroids)
5. The patient is neutropenic and receiving antimicrobial therapy
6. Suspected or proven Mycobacterium Tuberculosis
7. Antimicrobial therapy for proven bacterial infection requiring prolonged
antibiotic therapy for > 3 weeks (e.g. proven bacterial endocarditis, proven
bacterial meningitis, osteomyelitis, deep tissue infections)
8. The patients is receiving treatment for an isolated systemic viral infection
9. Cardiac surgery in the previous 48 hrs
10. Admission to ICU for multi-trauma or burns
11. Admission to ICU for environmental heatstroke
12. Patients with malignancies that are known to raise PCT levels (such as small
cell Carcinoma (Ca) of the Lung or C cell Ca of the Thyroid)
13. The patient not expected to survive > 24 hrs
14. The patient is receiving palliative care only, and is not expected to survive
hospital discharge
15. The patient is known to be pregnant.

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)
Allocation is done via central randomisation via computer.
Concealment done via computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random web based sequence
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

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)
Recruitment hospital [1] 1445 0
Prince of Wales Private Hospital - Randwick
Recruitment postcode(s) [1] 7279 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 257697 0
Charities/Societies/Foundations
Name [1] 257697 0
Intensive Care Foundation
Address [1] 257697 0
Intensive Care Foundation, Level 2, 10 Levers Tce, Carlton, VIC 3053
Country [1] 257697 0
Australia
Primary sponsor type
Hospital
Name
Prince of Wales Hospital
Address
Barker Street
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 256913 0
None
Name [1] 256913 0
Address [1] 256913 0
Country [1] 256913 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259730 0
St Vincents Ethics Committee
Ethics committee address [1] 259730 0
Victoria Rd
Darlighurst
NSW 2010
Ethics committee country [1] 259730 0
Australia
Date submitted for ethics approval [1] 259730 0
01/06/2010
Approval date [1] 259730 0
08/09/2010
Ethics approval number [1] 259730 0
HREC/09/SVH/103

Summary
Brief summary
Procalcitonin (PCT) is a marker of bacterial infection, severity of infection and response to therapy. This study aims to examine the use of this biomarker to guide antibiotic therapy in intensive care patients. We assume that a 25% reduction in exposure to antibiotic days can be produced by using a PCT guided algorithm.
Trial website
https://monashmed/proguardrand
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31678 0
A/Prof Yahya Shehabi
Address 31678 0
Intensive Care Unit
Prince of Wales Hospital
Barker St
Randwick NSW 2031
Country 31678 0
Australia
Phone 31678 0
+61293824721
Fax 31678 0
Email 31678 0
y.shehabi@unsw.edu.au
Contact person for public queries
Name 14925 0
A/Prof Yahya Shehabi
Address 14925 0
Barker St
Randwick
NSW 2031
Country 14925 0
Australia
Phone 14925 0
+61 2 93824721
Fax 14925 0
Email 14925 0
y.shehabi@unsw.edu.au
Contact person for scientific queries
Name 5853 0
A/Prof Yahya Shehabi
Address 5853 0
Barker St
Randwick
NSW 2031
Country 5853 0
Australia
Phone 5853 0
+61 2 93824721
Fax 5853 0
Email 5853 0
y.shehabi@unsw.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