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

Primary Purpose

Sepsis

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Procalcitonin-guided treatment
Conventional treatment
Sponsored by
Hunan Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis focused on measuring ICU, sepsis, antibiotic therapy, procalcitonin

Eligibility Criteria

1 Month - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hunan Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Procalcitonin-guided treatment

Conventional treatment

Arm Description

The duration of antibiotics will be determined by the procalcitonin levels.

The duration of antibiotics will be determined by the treating physician.

Outcomes

Primary Outcome Measures

Average antibiotics duration
Efficacy endpoint
28-day mortality rate
Safety endpoint

Secondary Outcome Measures

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

Full Information

First Posted
August 22, 2011
Last Updated
July 27, 2012
Sponsor
Hunan Children's Hospital
Collaborators
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01652404
Brief Title
PROcalcitonin to SHORTen Antibiotics Duration in PEDiatricICU Patients (ProShort-Ped) Trial
Acronym
ProShort-Ped
Official Title
PROcalcitonin to SHORTen Antibiotics Duration in PEDiatricICU Patients (ProShort-Ped) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hunan Children's Hospital
Collaborators
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis
Keywords
ICU, sepsis, antibiotic therapy, procalcitonin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Procalcitonin-guided treatment
Arm Type
Experimental
Arm Description
The duration of antibiotics will be determined by the procalcitonin levels.
Arm Title
Conventional treatment
Arm Type
Active Comparator
Arm Description
The duration of antibiotics will be determined by the treating physician.
Intervention Type
Behavioral
Intervention Name(s)
Procalcitonin-guided treatment
Intervention Description
The antibiotics duration will be determined by the serum procalcitonin level at day 5, 7 and 9.
Intervention Type
Behavioral
Intervention Name(s)
Conventional treatment
Intervention Description
The antibiotics duration will be determined by treating physician.
Primary Outcome Measure Information:
Title
Average antibiotics duration
Description
Efficacy endpoint
Time Frame
28 days
Title
28-day mortality rate
Description
Safety endpoint
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Proportion of antibiotics use in both arms
Description
Efficacy endpoint
Time Frame
28 days
Title
Length of ICU stay
Description
Efficacy endpoint
Time Frame
90 days
Title
Recurrence of fever within 72 hours of antibiotics discontinuation
Description
Safety endpoint
Time Frame
28 days
Title
SOFA score (Sequential Organ Failure Assessment score)
Description
Safety endpoint
Time Frame
28 days
Title
Reinfection rate between 72-hours and 28 days post antibiotics discontinuation
Description
Safety endpoint
Time Frame
28 days
Title
90-day all-cause mortality
Description
Safety endpoint
Time Frame
90 days
Title
90-day readmission rate
Description
Safety endpoint
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chien-Chang Lee, MD, MSc
Phone
886972651951
Email
cclee100@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yi-Min Zhu, BSc
Phone
073185356850
Email
csvzhuyimin@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chien-Chang Lee, MD, MSc
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yi-Min Zhu, BSc
Organizational Affiliation
Hunan Children's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Hunan Children's Hospital
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi-Min Zhu, BSc
Phone
073185386850
Email
csvzhuyimin@163.com
First Name & Middle Initial & Last Name & Degree
Yi-Min Zhu, BSc

12. IPD Sharing Statement

Citations:
PubMed Identifier
12535494
Citation
Michael M, Hodson EM, Craig JC, Martin S, Moyer VA. Short versus standard duration oral antibiotic therapy for acute urinary tract infection in children. Cochrane Database Syst Rev. 2003;(1):CD003966. doi: 10.1002/14651858.CD003966.
Results Reference
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PubMed Identifier
21034941
Citation
Lee SL, Islam S, Cassidy LD, Abdullah F, Arca MJ; 2010 American Pediatric Surgical Association Outcomes and Clinical Trials Committee. Antibiotics and appendicitis in the pediatric population: an American Pediatric Surgical Association Outcomes and Clinical Trials Committee systematic review. J Pediatr Surg. 2010 Nov;45(11):2181-5. doi: 10.1016/j.jpedsurg.2010.06.038.
Results Reference
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PROcalcitonin to SHORTen Antibiotics Duration in PEDiatricICU Patients (ProShort-Ped) Trial

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