Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-24 @ 9:21 PM
NCT ID:
NCT01652404
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Month
Maximum Age:
15 Years
Study:
NCT01652404
Study Brief:
Protocol Section:
NCT01652404