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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Hunan Children's Hospital.
Recruitment status was  Recruiting
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014