PROcalcitonin to SHORTen Antibiotics Duration in PEDiatricICU Patients (ProShort-Ped) Trial
NCT ID: NCT01652404
Last Updated: 2012-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
600 participants
INTERVENTIONAL
2011-03-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Procalcitonin-guided treatment
The duration of antibiotics will be determined by the procalcitonin levels.
Procalcitonin-guided treatment
The antibiotics duration will be determined by the serum procalcitonin level at day 5, 7 and 9.
Conventional treatment
The duration of antibiotics will be determined by the treating physician.
Conventional treatment
The antibiotics duration will be determined by treating physician.
Interventions
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Procalcitonin-guided treatment
The antibiotics duration will be determined by the serum procalcitonin level at day 5, 7 and 9.
Conventional treatment
The antibiotics duration will be determined by treating physician.
Eligibility Criteria
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Inclusion Criteria
\* 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
* 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
1 Month
15 Years
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Hunan Children's Hospital
OTHER_GOV
Responsible Party
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Principal Investigators
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Chien-Chang Lee, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital
Yi-Min Zhu, BSc
Role: STUDY_CHAIR
Hunan Children's Hospital
Locations
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Hunan Children's Hospital
Changsha, Hunan, China
Countries
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Central Contacts
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Facility Contacts
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Yi-Min Zhu, BSc
Role: primary
References
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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.
Other Identifiers
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HN01
Identifier Type: -
Identifier Source: org_study_id