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

This study is currently recruiting participants.
Verified July 2012 by Hunan Children's Hospital
Sponsor:
Collaborator:
National Taiwan University Hospital
Information provided by (Responsible Party):
Hunan Children's Hospital
ClinicalTrials.gov Identifier:
NCT01652404
First received: August 22, 2011
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

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).


Condition Intervention Phase
Sepsis
Behavioral: Procalcitonin-guided treatment
Behavioral: Conventional treatment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PROcalcitonin to SHORTen Antibiotics Duration in PEDiatricICU Patients (ProShort-Ped) Trial

Resource links provided by NLM:


Further study details as provided by Hunan Children's Hospital:

Primary Outcome Measures:
  • Average antibiotics duration [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Efficacy endpoint

  • 28-day mortality rate [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Safety endpoint


Secondary Outcome Measures:
  • Proportion of antibiotics use in both arms [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Efficacy endpoint

  • Length of ICU stay [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    Efficacy endpoint

  • Recurrence of fever within 72 hours of antibiotics discontinuation [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Safety endpoint

  • SOFA score (Sequential Organ Failure Assessment score) [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Safety endpoint

  • Reinfection rate between 72-hours and 28 days post antibiotics discontinuation [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Safety endpoint

  • 90-day all-cause mortality [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    Safety endpoint

  • 90-day readmission rate [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    Safety endpoint


Estimated Enrollment: 600
Study Start Date: March 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Procalcitonin-guided treatment
The duration of antibiotics will be determined by the procalcitonin levels.
Behavioral: Procalcitonin-guided treatment
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.
Behavioral: Conventional treatment
The antibiotics duration will be determined by treating physician.

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.

  Eligibility

Ages Eligible for Study:   1 Month to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01652404

Contacts
Contact: Chien-Chang Lee, MD, MSc 886972651951 cclee100@gmail.com
Contact: Yi-Min Zhu, BSc 073185356850 csvzhuyimin@163.com

Locations
China, Hunan
Hunan Children's Hospital Recruiting
Changsha, Hunan, China
Contact: Yi-Min Zhu, BSc    073185386850    csvzhuyimin@163.com   
Principal Investigator: Yi-Min Zhu, BSc         
Sponsors and Collaborators
Hunan Children's Hospital
National Taiwan University Hospital
Investigators
Principal Investigator: Chien-Chang Lee, MD, MSc National Taiwan University Hospital
Study Chair: Yi-Min Zhu, BSc Hunan Children's Hospital
  More Information

Publications:
Responsible Party: Hunan Children's Hospital
ClinicalTrials.gov Identifier: NCT01652404     History of Changes
Other Study ID Numbers: HN01
Study First Received: August 22, 2011
Last Updated: July 27, 2012
Health Authority: China: Ethics Committee

Keywords provided by Hunan Children's Hospital:
ICU
sepsis
antibiotic therapy
procalcitonin

Additional relevant MeSH terms:
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on April 15, 2014