CTTI Risk Factors for HABP/VABP Study (NCT02689531) | Clinical Trial Compass
CompletedNot Applicable
CTTI Risk Factors for HABP/VABP Study
United States7,530 participantsStarted 2016-02
Plain-language summary
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).
Who can participate
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Development of HABP/VABP
Timeframe: Through completion of the study, up to 12 months
2
Eligibility for typical antibacterial clinical trial
Timeframe: Through completion of the study, up to 12 months