The use of an infection biomarker (Procalcitonin blood level) to guide antibiotic use in intensive care patients

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000809033

Acronym

(ProGUARD-ICU)

Enrollment

400

Registered

2010-09-28

Start date

2011-02-25

Completion date

2012-12-21

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

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.

Outcome results