CTTI Risk Factors for HABP/VABP Study

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pneumonia, as defined by the FDA draft guidance document for drug development in HABP/VABP.
Subjects who meet the FDA draft guidance definition of pneumonia will have vitals and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.

Inclusion Criteria (Adult arm => 18 years old):

- Admission to participating ICU

- Hospitalized for >48 hours or admitted <7 days after discharge from an inpatient acute
or chronic care facility

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:

- Invasive mechanical ventilation

- Noninvasive ventilation (BiPAP or CPAP for any indication other than obstructive sleep
apnea)

- High-flow, supplemental oxygen therapy via nasal cannula. Only include systems that
using an air/oxygen blender capable of delivering a precise FiO2 level, not just a
flow in LPM.

- High flow supplemental oxygen therapy delivering at least 50% FiO2 via aerosol
facemask or tracheostomy collar (mask). Only include systems using an air/oxygen
blender capable of delivering a precise FiO2 level, not just a flow in LPM.

- Supplemental oxygen therapy delivered via either partial or non-rebreather face mask

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):

- Age <18 years old

- Pregnancy (current) or breastfeeding

- Lung cancer or another malignancy metastatic to the lungs (currently receiving
treatment)

- Patient previously enrolled and treated for suspected HABP or VABP (More than CRF Part
1 was previously completed)

- Patient is on comfort measures (e.g. would not receive antibiotics)

Inclusion Criteria (Pediatric Arm: < 18 years old)

- < 18 years old

- Admission to participating ICU or intermediate care unit

- Hospitalized for >48 hours or admitted <7 days after discharge from an inpatient acute
or chronic care facility Note: Children and infants with pulmonary and cardiac
anomalies are eligible to participate.

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:

- Invasive mechanical ventilation via endotracheal intubation

- New initiation of mechanical ventilation, BiPAP or CPAP via tracheostomy

- Noninvasive ventilation (BiPAP or CPAP for any indication other than obstructive sleep
apnea)

- High-flow, supplemental oxygen therapy delivering at least 1.5LMP with 100% FiO2 via
nasal cannula when delivered using an air/oxygen blender capable of delivering a
precise FiO2 level, not just a flow in LPM

- High flow supplemental oxygen therapy delivering at least 50% FiO2 via aerosol
facemask or tracheostomy collar (mask) when delivered using an air/oxygen blender
capable of delivering a precise FiO2 level, not just a flow in LPM

- Supplemental oxygen therapy delivered via either partial or non-rebreather face mask

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)

- Known pregnancy (current) or breastfeeding

- Lung cancer or another malignancy metastatic to the lungs (currently receiving
treatment)

- Patient previously enrolled and treated for suspected HABP or VABP (More than
Pediatric CRF Part 1 was previously completed)

- Patient is on comfort measures (e.g. would not receive antibiotics)