Characterize Novel Pathogen- and Host- Related Factors in Hospitalized Patients and Patients on the Emergency Department Presenting With Lower Respiratory Tract Infections and/or Sepsis

NCT02093247 | Unknown

• 1 other identifier: 0006-14-HMO
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is Observational multi-center, prospective study to characterize novel pathogen- and host-related factors in hospitalized patients and patients in the Emergency Department (ED) presenting with lower respiratory tract infections (LRTI) and/or sepsis.The Study's objective is to develop a novel multi-parametric diagnostic model for the management of patients with LRTI and/or sepsis that will be based on novel pathogen- and host-related factors.

Conditions

Lower Respiratory Tract Infection

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity ≥70% for host-related individual biomarkers, in differentiating bacterial or viral or fungal etiology from other etiologies in patients with LRTI and/or sepsis

  The assesment of the sensitivity and specificity of a multi-parametric diagnostic model, incorporating different pathogen- and host-related factors, in differentiating between bacterial and viral etiology in patients with LRTI and/or sepsis

  4 years

Secondary Outcomes (2)

• Sensitivity and specificity ≥70% for host-related individual biomarkers, in differentiating bacterial or viral or fungal etiology from other etiologies in patients with LRTI and/or sepsis

  4 years

• To build a web-based application that provides physicians with a recommended antimicrobial treatment based on patients clinical, molecular and biochemical data.

  4 years

Other Outcomes (4)

• Sensitivity and specificity ≥70% for sets of blood biomarkers, in differentiating Gram positive or Gram negative or atypical etiology from other disease etiologies in patients with LRTI and/or sepsis

  4 years

• Monitoring the temporal dynamics concentrations of blood biomarkers levels during the course of disease in patients with LRTI and/or sepsis

  4 years

• A list of significant bacterial microbiome components that are associated with poor or favorable clinical outcome in patients with LRTI and/or sepsis

  4 years

Eligibility Criteria

• Age: 1 Month - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible subjects aged one month of age and older from both genders that attend the hospital or the ED due to a suspected respiratory infections and/or sepsis (whose onset of symptoms began ≤8 days prior to recruitment) or due to a non-infectious disease. These subjects are expected to fall into one of the following categories: 1. Patients with an acute bacterial infection 2. Patients with an acute viral infection 3. Patients with an acute mixed co-infection (bacterial and viral) 4. Patients with a fungal infection 5. Patients with an undetermined disease etiology 6. Patients with a non-infectious disease (control group) Patients from subgroups 1-6 will also be classified based on the presence or absence of sepsis or severe sepsis. Children in group 6 can only be included when blood sampling for this study can be combined with blood sampling as part of standard of care.

You may qualify if:

• The LRTI disease group should also 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
• The Sepsis group should also 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 (in adults):
• 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 which must be abnormal temperature or white blood cell count
• Severe sepsis is defined as sepsis plus one of the following:
• The non-infectious disease group will include:
• Patients with a non-infectious disease. 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.

You may not qualify if:

• 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
• Patients with a nosocomial 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 or 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.

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2014
• First Posted: March 20, 2014
• Study Start: June 1, 2014
• Primary Completion: July 1, 2016
• Last Updated: March 20, 2014

Record last verified: 2014-03