Procalcitonin to Shorten Antibiotics Duration in ICU Patients (ProShort)

National Taiwan University

Status and phase: Unknown; Phase 3

Conditions: Sepsis

Treatments: Behavioral: Procalcitonin guided antibiotics treatment algorithm; Behavioral: Conventional treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01379547

201101079RB

Details and patient eligibility

About

The trial is aimed to show that implementation of a procalcitonin-guided antibiotics algorithm may result in shortened antibiotics course in ICU sepsis patients without inferior outcome as compared to the conventional therapy

Full description

The duration of antibiotic therapy in patients with sepsis is largely empirical. An extended treatment course for up to two weeks is a common practice for patients with sepsis in the ICU, despite lack of evidence for this duration of therapy.

Procalcitonin (PCT) is a new biomarker that has high negative predictive value for systemic bacterial infection. The purpose of this trial is to evaluate whether serial PCT measurements can shorten antibiotic treatment duration in patients with sepsis in the ICU.

Specific Aims

1. To show that implementation of a procalcitonin-guided antibiotics stewardship algorithm may result in shortened antibiotics course in ICU sepsis patients
2. To show that implementation of a procalcitonin-guided antibiotics stewardship algorithm may not result in inferior outcome as compared to conventional therapy

Enrollment: 1,700 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients with laboratory- or image-confirmed severe infection at admission or during stay in ICU will be eligible for inclusion.

Definition of laboratory- or image-confirmed severe infection:

1. Two or more of four Signs of Inflammation

   • Temperature > 38.3℃ or < 36℃
   • Heart rate > 90 beats/min
   • Respiratory rate > 20 breaths/min or PaCO2 < 32 mmHg
   • WBC > 12,000 cells/mm3, < 4000 cells/mm3, or > 10% bands

2. Initial Procalcitonin > 0.5 ng/mL

3. Presence of either laboratory or image evidence of infection

Laboratory evidence:

Sign of inflammation in urine, CSF, ascites, pleural effusion or local abscess

Image evidence:

Compatible findings on Chest X ray、ultrasound、CT、or MR image

Exclusion criteria

• Age less than 20 years
• Known pregnancy
• Presence of DNR order
• Expected ICU stay less than 3 days
• Neutropenia (ANC count < 500/mm3)
• Specific infections for which long-term antibiotic treatment is strongly recommended: lung abscess or empyema, bacterial meningitis, osteomyelitis, infective endocarditis, local abscess, mediastinitis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,700 participants in 2 patient groups

Conventional Treatment

Active Comparator group

Description:

Patients who will be randomized to arm 1 will receive antibiotic therapy with a duration based on conventional practice

Treatment:

Behavioral: Conventional treatment

procalcitonin-guided antibiotics treatment

Experimental group

Description:

Patients who will be randomized to arm 2 will receive antibiotics therapy with a duration based on procalcitonin-guided algorithm.

Treatment:

Behavioral: Procalcitonin guided antibiotics treatment algorithm