Prospective Study to Characterize Host-pathogen Related Factors in Hospitalized and ED Patients W… (NCT02025699) | Clinical Trial Compass
CompletedNot Applicable
Prospective Study to Characterize Host-pathogen Related Factors in Hospitalized and ED Patients With LRTI and/or Sepsis
Israel1,200 participantsStarted 2014-02
Plain-language 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.
Who can participate
Age range1 Month – 120 Years
SexALL
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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 Confe…
What they're measuring
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