NL-OMON44266
Completed
Not Applicable
Observational multi-center, prospective study to develop a novel multi-parametric diagnostic model for hospitalized patients and patients on the Emergency Department presenting with lower respiratory tract infections and/ or sepsis. - The TAILORED-treatment Study
niversitair Medisch Centrum Utrecht0 sites467 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- sepsis en virale infecties
- Sponsor
- niversitair Medisch Centrum Utrecht
- Enrollment
- 467
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients (children and adults) who are at least 1 month old of age that attend the hospital or the ED due to suspected respiratory infections and/or sepsis (whose onset of symptoms began \* 8 days prior of recruitment) or due to a non\-infectious desease, will be eligible for inclusion.;\-The LRTI disease group should fulfill the following criteria:
- •Presence of two or more of the following signs of respiratory distress:
- •\-Tachypnea \*
- •\-(Chest)Cough
- •\-Nasal flaring
- •\-Retractions
- •\-Expiratory wheeze and/or decreased breath sounds;\* (WHO age\- specific criteria for tachypnea wil be used: a respiratory rate of more than 50 breaths per minute in infants 2\-12 months of age; more than 40 breaths per minute in children 1\-5 years of age; and more than 30 breaths in children older than 5 years);\-The Sepsis group should fulfill the following criteria:
- •Sepsis will be defined as a combination of a systemic inflammatory response syndrome (SIRS) due to infectious agent. SIRS will be determined according to published criteria (the International Sepsis Definitions Conference, 2001\) based on
- •\-Heart rate (higher than 90/min)
- •\-Respiratory rate (higher than 20/min or PaCO2 lower than 32 mmHg)
Exclusion Criteria
- •\-An episode of febrile infection during the past 3 weeks
- •\-A proven or suspected human immunodeficiency virus (HIV)\-1, hepatitis B virus (HBV), or hepatitis C virus (HCV) infection
- •\-Presence of obvious alternative causes of respiratory distress, such as heart failure or pneumothorax
- •\- Patiënten met een nosocomiale LRTI (developed \> 3days after hospitalization)
- •\-Post\-transplant patients
- •\-Congenital immune deficiency (CID)
- •\-Active hematological malignancy
- •\-Current treatment with immune\-suppressive or immune\-modulating therapies including:
- •\* \-Chemotherapy
- •\* \-Radiotherapy
Outcomes
Primary Outcomes
Not specified
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