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The purpose of this study is to better define the intensive care unit population at highest risk for developing Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP).
Full description
This is a prospective, multi-center, observational study of adult patients (≥18 years old) admitted to ICUs. Generally, all patients admitted to the ICU for any indication will be considered at risk for developing HABP/VABP. A subset of the at-risk patients treated with select respiratory modalities for at least 12 hours will be considered high risk for the development of HABP/VABP, will have baseline data collected, and will be screened daily for antibiotic treatment for suspected pneumonia. Patients not meeting high-risk criteria, "other-ICU patients", will be screened twice weekly for antibiotic treatment for suspected pneumonia.
Once a high-risk subject or other-ICU patient is treated with antibiotics for either a lower respiratory tract infection (LRTI) or undifferentiated sepsis, additional clinical information will be recorded from the subject's medical record. All subjects treated with antibiotics for either indication will subsequently be screened for the development of pneumonia, as defined by the FDA draft guidance document for drug development in HABP/VABP. Subjects who meet the FDA draft guidance definition of pneumonia will have vitals and physiologic data collected and will be followed for 4 days after pneumonia is diagnosed to capture the results of any microbiologic testing and changes to initial antibiotic therapy.
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Inclusion and exclusion criteria
Inclusion Criteria (Adult arm => 18 years old):
High-Risk Inclusion (Adult arm => 18 years old):
Treated with one or more of the following respiratory modalities for at least 12 hours, either currently or within the prior 7 days:
Other-ICU Inclusion(Adult arm => 18 years old):
All patients who meet ICU and time-frame eligibility criteria, but do not fulfill high-risk criteria, and are receiving an antibiotic for treatment of LRTI or undifferentiated sepsis.
Exclusion Criteria(Adult arm => 18 years old):
Inclusion Criteria (Pediatric Arm: < 18 years old)
High-Risk Inclusion (Pediatric Arm: < 18 years old)
Subjects ≥120 days old and <18 years old:
Currently treated with one or more of the following respiratory modalities for at least 24 hours:
Subjects <120 days old:
Currently treated with mechanical ventilation via endotracheal intubation for at least 5 days
Standard-Risk Inclusion (Pediatric Arm: < 18 years old) All patients who meet pediatric eligibility criteria, but do not fulfill high-risk criteria, and are receiving an antibiotic for treatment of LRTI or undifferentiated sepsis.
Exclusion Criteria (Pediatric Arm: < 18 years old)
7,530 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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