NCT02202941

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for not_applicable sepsis

Timeline
Completed

Started Aug 2014

Shorter than P25 for not_applicable sepsis

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 29, 2014

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

November 2, 2018

Status Verified

November 1, 2018

Enrollment Period

6 months

First QC Date

July 24, 2014

Last Update Submit

November 1, 2018

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

  • Duration of antibiotic treatment

    up to 28 days

Secondary Outcomes (4)

  • Clinical response to treatment for infection

    up to 28 days

  • In ICU mortality

    up to 28 days

  • All cause mortality

    up to 28 days

  • In hospital mortality

    up to 90 days

Study Arms (2)

Procalcitonin guided treatment

EXPERIMENTAL

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

Other: Procalcitonin guided treatment

Conventional treatment

ACTIVE COMPARATOR

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

Other: Conventional treatment

Interventions

Procalcitonin guided treatmentOTHER

Patients who will be randomized to arm will receive antibiotics therapy based on procalcitonin measurement on day 1, 3, 5, 7, 9, 11 and 13.

Procalcitonin guided treatment
Conventional treatmentOTHER

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

Conventional treatment

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Severance Hospital

Seoul, South Korea

Location

Related Publications (1)

  • Jeon K, Suh JK, Jang EJ, Cho S, Ryu HG, Na S, Hong SB, Lee HJ, Kim JY, Lee SM. Procalcitonin-Guided Treatment on Duration of Antibiotic Therapy and Cost in Septic Patients (PRODA): a Multi-Center Randomized Controlled Trial. J Korean Med Sci. 2019 Apr 15;34(14):e110. doi: 10.3346/jkms.2019.34.e110.

    PMID: 30977312DERIVED

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sang-Min Lee, M.D.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

July 24, 2014

First Posted

July 29, 2014

Study Start

August 1, 2014

Primary Completion

February 1, 2015

Study Completion

March 1, 2015

Last Updated

November 2, 2018

Record last verified: 2018-11

Locations

KR(4)