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.

Completed

• Conditions: sepsis en virale infecties; Lower Respiratory Tract Infection and Sepsis; 10004018; 10024970

• Registration Number: NL-OMON44266
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2016-06-27
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 467

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
-Rales
-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)
-Core body temperature (higher than 38°C or lower than 36°C)
-White blood cell count (higher than 12,000 cells/ µl or lower than 4,000/ µl);SIRS is defined as at least two of the above criteria, one of wich must be abnormal temperature or white blood cell count.;-Children with sepsis
As normal physiological variables are different for children, the SIRS criteria are defined seperately for children under 18. SIRS criteria per age group are defined according to guidelines of the International Pediatric Sepsis Consensus Conference 2005 (Pediatric Critical care Medicine , 6(1); 2-8, 2005) Protocol pag. 29-30 The criteria are also based on heart rate, respiratory rate, core body temperature and white blood cell count.
In children SIRS is also defined as at least two of the above criteria, one of wich must be abnormal temperature or white blood cell count.;The non-infectious disease group will include:
-Patients with a non-infectious disease
The non-infectious diseases group will be composed of patients that had other diseases that are not considered as infectious. These patients are expected to demonstrate inflammatory processes that are not infection-orginated (e.g. acute myocardial infarction, bone fractures ect.)
Children in this group can only be included when blood sampling for this study can be combined with blood sampling as part of standard of care.

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
* -High dose steroids >1 mg/kg/day prednisone or equivalent in the past two weeks
* -Monoclonal antibody or Intravenous IgG (IVIG)
-Cyclosporine
* -Anti-TNF agents
* -Interferon (of all kinds)
-Other severe illnesses that affect life expectancy and quality of life such as:
* -Moderate to severe psychomotor retardation
-Moderate to severe congenital metabolic disorder
-In children only: Other severe illnesses affecting life expectancy less than one year.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Sensitivity and specificity for a multi-parametric diagnostic model,<br /><br>incorporating different pathogen- and host-related factors, in differentiating<br /><br>between bacterial and viral etiology in patients with LRTI and/or sepsis</p><br>