Prospective Study to Characterize Host-pathogen Related Factors in Hospitalized and ED Patients With LRTI and/or Sepsis

NCT02025699 | Completed DMC

• 1 other identifier: MM-1004-TT
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

The TAILORED-Treatment consortium was established to develop new tools aimed to increase the effectiveness of antibiotic and antifungal therapy, reduce adverse events, and help limit the emergence of antimicrobial resistance in children and adults.

Conditions

LRTI; Sepsis; Fungal Infections; Bacteremia; Fever Without Source

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity for 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

  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 (6)

• 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

• 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

• Sensitivity and specificity ≥70% for liquid chromatography-mass spectrometry and lipid-based Protein Immobilization proteomics-based rapid detection technique in identifying pathogens in clinical samples of patients with LRTI and/or sepsis

  4 years

Study Arms (3)

LRTI

Sepsis

Non-Infectious disease group

Eligibility Criteria

• Age: 1 Month - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: 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 (onset of symptoms ≤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.

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

• MeMed Diagnostics Ltd.: lead
• European Commission: collaborator

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, Israel

Location

Related Publications (1)

• van Houten CB, Oved K, Eden E, Cohen A, Engelhard D, Boers S, Kraaij R, Karlsson R, Fernandez D, Gonzalez E, Li Y, Stubbs A, Moore ERB, Hays JP, Bont LJ. Observational multi-centre, prospective study to characterize novel pathogen-and host-related factors in hospitalized patients with lower respiratory tract infections and/or sepsis - the "TAILORED-Treatment" study. BMC Infect Dis. 2018 Aug 7;18(1):377. doi: 10.1186/s12879-018-3300-9.

  PMID: 30086729 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples Nasopharyngeal samples

MeSH Terms

Conditions

Sepsis; Mycoses; Bacteremia

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacterial Infections and Mycoses; Bacterial Infections

Study Officials

• Kfir Oved, Dr.

  MeMed Diagnostics Ltd.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: December 23, 2013
• First Posted: January 1, 2014
• Study Start: February 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: September 1, 2016
• Last Updated: January 13, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)