Procalcitonin-guided Treatment on Duration of Antibiotic Therapy and Cost in Septic Patients (PRODA)

Seoul National University

Status: Completed

Conditions: Sepsis

Treatments: Other: Conventional treatment; Other: Procalcitonin guided treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02202941

PRODA-2014

Details and patient eligibility

About

This clinical trial is aimed to show a procalcitonin-guided treatment algorithm may shorten duration of antibiotic therapy safely and cost-effectively in sepsis patients of Korean ICU.

Enrollment: 62 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients with suspicious or confirmed sepsis at admission or during stay in ICU
• Patients with antibiotic duration of less than 48 hours before enrollment

Exclusion criteria

• Age less than or equal to 18 years
• Known pregnancy
• Specific infections for which long-term antibiotic treatment for 3 weeks more is strongly recommended: infective endocarditis, empyema, osteomyelitis et al.
• severe immunocompromised patients : HIV infected patients (CD4 count < 200 cells/mm3), Neutropenia (ANC count < 500/mm3)
• Presence of do-not-resuscitate order

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Procalcitonin guided treatment

Experimental group

Description:

Patients who will be randomized to this arm will receive antibiotics therapy based on procalcitonin-guided algorithm.

Treatment:

Other: Procalcitonin guided treatment

Conventional treatment

Active Comparator group

Description:

Patients who will be randomized to this arm will receive antibiotic therapy based on conventional practice.

Treatment:

Other: Conventional treatment