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

Hunan Children's Hospital

Status and phase: Unknown; Phase 3

Conditions: Sepsis

Treatments: Behavioral: Conventional treatment; Behavioral: Procalcitonin-guided treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01652404

HN01

Details and patient eligibility

About

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).

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 1 month to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

Procalcitonin-guided treatment

Experimental group

Description:

The duration of antibiotics will be determined by the procalcitonin levels.

Treatment:

Behavioral: Procalcitonin-guided treatment

Conventional treatment

Active Comparator group

Description:

The duration of antibiotics will be determined by the treating physician.

Treatment:

Behavioral: Conventional treatment