PROcalcitonin to SHORTen Antibiotics Duration in PEDiatricICU Patients (ProShort-Ped) Trial (ProShort-Ped)

July 27, 2012 updated by: Hunan Children's Hospital
The purpose of this study is to give conclusive evidence on whether serial PCT (Procalcitonin) measurements can facilitate individual decision-making and shorten antibiotic treatment duration in patients with sepsis in the pediatric ICU (Intensive Care Unit).

Study Overview

Detailed Description

In this study, the investigators aimed to design a multi-center trial addressing aforementioned flaws. The investigators will set stricter inclusion criteria, collect complete data on relapse or secondary infection, and include sufficient number of patients to show non-inferiority to conventional therapy by a delta margin of 10% [11]. The investigators aimed to give conclusive evidence on whether serial PCT measurements can facilitate individual decision-making and shorten antibiotic treatment duration in patients with sepsis in the pediatric ICU.

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Hunan
      • Changsha, Hunan, China
        • Recruiting
        • Hunan Children's Hospital
        • Contact:
        • Principal Investigator:
          • Yi-Min Zhu, BSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

* 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 (Arterial pressure of carbon dioxide) < 32 mmHg
    • WBC (White Blood Cell count) > 12,000 cells/mm3, <4000 cells/mm3, or >5% band-form WBC
  • Initial Procalcitonin > 0.5 ng/mL
  • Presence of either laboratory or image evidence of infection
  • Laboratory evidence: Sign of inflammation in urine, CSF (Cerebrospinal Fluid), ascites, pleural effusion or local abscess
  • Image evidence: Compatible findings on Chest X ray, ultrasound, CT (Computed Tomography), MR image (Magnetic Resonance Image)

Exclusion Criteria:

  • Age greater than 15 years or less than 1 month
  • Known pregnancy
  • Expected ICU stay less than 3 days
  • Neutropenia: ANC (Absolute Neutrophil Count) <500/mm3
  • Specific infections for which long-term antibiotic treatment is strongly recommended:

    • Lobar pneumonia or empyema
    • Bacterial meningitis
    • Osteomyelitis
    • Infective endocarditis
    • Local abscess
    • Mediastinitin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Procalcitonin-guided treatment
The duration of antibiotics will be determined by the procalcitonin levels.
The antibiotics duration will be determined by the serum procalcitonin level at day 5, 7 and 9.
Active Comparator: Conventional treatment
The duration of antibiotics will be determined by the treating physician.
The antibiotics duration will be determined by treating physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average antibiotics duration
Time Frame: 28 days
Efficacy endpoint
28 days
28-day mortality rate
Time Frame: 28 days
Safety endpoint
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of antibiotics use in both arms
Time Frame: 28 days
Efficacy endpoint
28 days
Length of ICU stay
Time Frame: 90 days
Efficacy endpoint
90 days
Recurrence of fever within 72 hours of antibiotics discontinuation
Time Frame: 28 days
Safety endpoint
28 days
SOFA score (Sequential Organ Failure Assessment score)
Time Frame: 28 days
Safety endpoint
28 days
Reinfection rate between 72-hours and 28 days post antibiotics discontinuation
Time Frame: 28 days
Safety endpoint
28 days
90-day all-cause mortality
Time Frame: 90 days
Safety endpoint
90 days
90-day readmission rate
Time Frame: 90 days
Safety endpoint
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Chien-Chang Lee, MD, MSc, National Taiwan University Hospital
  • Study Chair: Yi-Min Zhu, BSc, Hunan Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

August 22, 2011

First Submitted That Met QC Criteria

July 27, 2012

First Posted (Estimate)

July 30, 2012

Study Record Updates

Last Update Posted (Estimate)

July 30, 2012

Last Update Submitted That Met QC Criteria

July 27, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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