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
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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