- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01652404
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
Status
Unknown
Conditions
Intervention / Treatment
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
- Name: Chien-Chang Lee, MD, MSc
- Phone Number: 886972651951
- Email: cclee100@gmail.com
Study Contact Backup
- Name: Yi-Min Zhu, BSc
- Phone Number: 073185356850
- Email: csvzhuyimin@163.com
Study Locations
-
-
Hunan
-
Changsha, Hunan, China
- Recruiting
- Hunan Children's Hospital
-
Contact:
- Yi-Min Zhu, BSc
- Phone Number: 073185386850
- Email: csvzhuyimin@163.com
-
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.
Sponsor
Collaborators
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.
General Publications
- 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.
- 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.
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HN01
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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