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

 In reality, targeted antimicrobial therapy can most effectively be achieved by utilizing
 personalized data to facilitate a tailored and optimized approach to individual patient
 treatment. This can best be achieved by utilizing knowledge gained from both host-centered
 and pathogen-centered parameters during health and disease. Unfortunately, these parameters
 have traditionally, tended to be measured independently (for example using microbial culture
 or PCR-based methods for microbial detection, or measurement of the immune response to
 infections and/or blood-based biomarkers in the host), and used on an ad hoc basis without
 careful integration for the best treatment of the patient. However, recent advances in the
 development of high-throughput and sensitive molecular-based technologies, on-line internet
 database access tools, and bioinformatics analysis, now means that the goal of personalized
 medicine and treatment is in sight. Unfortunately however, there currently exists a
 technological gap between recent state-of-the-art methodologies (for example with respect to
 gaining new insights into novel host-pathogen interactions) and laboratory-to-bedside results
 to benefit patients, physicians and society as a whole. The TAILORED-Treatment project is
 designed to bridge this technological gap in order to generate novel insights and innovations
 that are readily exploitable for the maximum benefit of multiple stakeholders in the field of
 personalized medicine and infectious diseases.
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.