Sepsis Clinical Trial
— TailoredTOfficial title:
Observational Multi-center, Prospective Study to 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.
Verified date | January 2017 |
Source | MeMed Diagnostics Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1200 |
Est. completion date | September 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 1 Month to 120 Years |
Eligibility |
Inclusion Criteria : Patients who are at least one month old will be eligible for inclusion. 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: Cardiovascular failure Acute respiratory distress syndrome Two or more other organ failure As normal physiological variables are different for children, the SIRS criteria are defined separately for children under 18. SIRS and severe sepsis criteria per age group are defined in details in the "Population/Inclusion criteria" section below, according to guidelines of the International Pediatric Sepsis Consensus Conference (2005). 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. 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 - 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. |
Country | Name | City | State |
---|---|---|---|
Israel | Hillel Yaffe Medical Center | Hadera |
Lead Sponsor | Collaborator |
---|---|
MeMed Diagnostics Ltd. | European Commission |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | To identify host-related individual biomarkers that have sensitivity and specificity of =70% in differentiating bacterial or viral or fungal etiology from other etiologies in patients with LRTI and/or sepsis | 4 years | |
Secondary | 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 | To identify sets of blood biomarkers with sensitivity and specificity of =70% in differentiating Gram positive or Gram negative or atypical etiology from other disease etiologies in patients with LRTI and/or sepsis | 4 years | |
Secondary | Monitoring the temporal dynamics concentrations of blood biomarkers levels during the course of disease in patients with LRTI and/or sepsis | To monitor the temporal dynamics concentrations of blood bio-markers levels during the course of disease in patients with LRTI and/or sepsis including determination of the time required to reach peak levels and the time required to return to normal values. | 4 years | |
Secondary | A list of significant bacterial microbiome components that are associated with poor or favorable clinical outcome in patients with LRTI and/or sepsis | To create 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 | |
Secondary | 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 | To achieve sensitivity and specificity of =70% for liquid chromatography-mass spectrometry (LC-MS/MS) and lipid-based Protein Immobilization (LPI) proteomics-based rapid detection technique in identifying pathogens in clinical samples of patients with LRTI and/or sepsis | 4 years | |
Secondary | To build a web-based application that provides physicians with a recommended antimicrobial treatment based on patients clinical, molecular and biochemical data. | To create an open web-based application that provides physicians with a recommended antimicrobial treatment based on a patient clinical, molecular and biochemical data. | 4 years |
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