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

Not Applicable

Completed

• Conditions: Sepsis
• Interventions: Other: Procalcitonin guided treatment; Other: Conventional treatment

• Registration Number: NCT02202941
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-24
• Study First Submitted QC: 2014-07-25
• Study First Posted: 2014-07-29
• Study Start: 2014-08
• Primary Completion: 2015-02
• Study Completion: 2015-03
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-01
• Last Update Posted: 2018-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Procalcitonin guided treatment	Procalcitonin guided treatment	Patients who will be randomized to this arm will receive antibiotics therapy based on procalcitonin-guided algorithm.
Conventional treatment	Conventional treatment	Patients who will be randomized to this arm will receive antibiotic therapy based on conventional practice.

Primary Outcome Measures

Name	Time	Method
Duration of antibiotic treatment	up to 28 days

Secondary Outcome Measures

Name	Time	Method
Clinical response to treatment for infection	up to 28 days	success vs failure vs relapse after treatment
In hospital mortality	up to 90 days
All cause mortality	up to 28 days
In ICU mortality	up to 28 days

Trial Locations

Locations (4)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of