Clinical trial NCT01652404: PROcalcitonin to SHORTen Antibiotics Duration in PEDiatricICU Patients (ProShort-Ped) Trial
Official title: PROcalcitonin to SHORTen Antibiotics Duration in PEDiatricICU Patients (ProShort-Ped) Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Sepsis
Keywords: ICU
sepsis
antibiotic therapy
procalcitonin
Lead sponsor: Hunan Children's Hospital
Sponsor class: OTHER_GOV
Collaborators: name: National Taiwan University Hospital
First posted: 2012-07-30
Enrollment: 600
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Average antibiotics duration
timeFrame: 28 days
measure: 28-day mortality rate
timeFrame: 28 days
Secondary outcomes:
measure: Proportion of antibiotics use in both arms
timeFrame: 28 days
measure: Length of ICU stay
timeFrame: 90 days
measure: Recurrence of fever within 72 hours of antibiotics discontinuation
timeFrame: 28 days
measure: SOFA score (Sequential Organ Failure Assessment score)
timeFrame: 28 days
measure: Reinfection rate between 72-hours and 28 days post antibiotics discontinuation
timeFrame: 28 days
measure: 90-day all-cause mortality
timeFrame: 90 days
measure: 90-day readmission rate
timeFrame: 90 days
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Children's Hospital
state: Hunan
Study officials:
affiliation: National Taiwan University Hospital
name: Chien-Chang Lee, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Hunan Children's Hospital
name: Yi-Min Zhu, BSc
role: STUDY_CHAIR
References:
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.
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.