NCT01379547

Brief Summary

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

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,700

participants targeted

Target at P75+ for phase_3 sepsis

Timeline
Completed

Started Jun 2011

Geographic Reach
3 countries

8 active sites

Status
unknown

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

Study Start

First participant enrolled

June 1, 2011

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

June 21, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 23, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

November 27, 2012

Status Verified

November 1, 2012

Enrollment Period

1.5 years

First QC Date

June 21, 2011

Last Update Submit

November 26, 2012

Conditions

Sepsis

Keywords

ProcalcitoninsepsisICUantibioticantibiotic durationAntibiotic treatment duration

Outcome Measures

Primary Outcomes (2)

  • Average antibiotics duration

    28 days

  • 28-day mortality rate

    Safety endpoints

    28 days

Secondary Outcomes (7)

  • Proportion of antibiotics use in both arms

    28 days

  • Length of ICU stay

    90 days

  • Recurrence of fever within 72 hours of antibiotics discontinuation

    28 days

  • APACHE-II score or SOFA score

    28 days

  • Reinfection between 72-hours and 28 days post antibiotics discontinuation

    28 days

  • +2 more secondary outcomes

Study Arms (2)

Conventional Treatment

ACTIVE COMPARATOR

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

Behavioral: Conventional treatment

procalcitonin-guided antibiotics treatment

EXPERIMENTAL

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

Behavioral: Procalcitonin guided antibiotics treatment algorithm

Interventions

Procalcitonin guided antibiotics treatment algorithmBEHAVIORAL

Patients who will be randomized to arm 2 will receive antibiotics therapy with a duration based on procalcitonin measurement on day 5, 7 and 9.

procalcitonin-guided antibiotics treatment
Conventional treatmentBEHAVIORAL

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

Conventional Treatment

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Definition of laboratory- or image-confirmed severe infection:
  • 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
  • Initial Procalcitonin \> 0.5 ng/mL
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Department of Critical Care Medicine, The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

RECRUITING

Department of Critical Care Medicine, The 301 People Liberation Army General Hospital

Beijing, China

NOT YET RECRUITING

Emergency Department, Beijing Chao-Yang Hospital, Capital Medical University

Beijing, China

RECRUITING

Emergency Department, Ruijin Hospital, Jiaotong University, School of Medicine

Shanghai, China

RECRUITING

Emergency Department, Xinhua Hospital, Jiaotong University School of Medicine

Shanghai, China

RECRUITING

Department of Critical Care Medicine, The General Hospital of Tianjin Medical University

Tianjin, China

RECRUITING

Department of Pathology, Princess Margaret Hospita

Lai Chi Kok, Hong Kong

NOT YET RECRUITING

Department of Emergency, National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Chien-Chang Lee, MD, MSc

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chien-Chang Lee, MD, MSc

CONTACT

+886-972-651951cclee100@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2011

First Posted

June 23, 2011

Study Start

June 1, 2011

Primary Completion

December 1, 2012

Study Completion

June 1, 2013

Last Updated

November 27, 2012

Record last verified: 2012-11

Locations

HK(1)TW(1)CN(6)