To estimate the incidence of S. aureus and P. aeruginosa ICU pneumonia, especially VAP, and to assess its association with patient-related and contextual factors, e.g. colonization status, serum antibody levels against S. aureus alpha toxin [AT],…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcomes are the incidence of S. aureus ICU acquired pneumonia and
the incidence of P. aeruginosa ICU acquired pneumonia through ICU stay.
Secondary outcome
- colonization with S. aureus at ICU admission
- colonization with P. aeruginosa at ICU admission
- mortality through day-90 post ICU admission
- time to primary outcomes in days
Background summary
Intensive Care Unit (ICU) acquired pneumonia, including ventilator-associated
pneumonia (VAP), is a frequently occurring health-care associated infection
(HAI), which causes considerable morbidity, mortality and health care costs.
Important pathogens causing ICU pneumonia are Staphylococcus aureus and
Pseudomonas aeruginosa. The epidemiology of ICU pneumonia and patient-related
and contextual factors is not fully described, but is urgently needed to
support the development of effective interventions.
Study objective
To estimate the incidence of S. aureus and P. aeruginosa ICU pneumonia,
especially VAP, and to assess its association with patient-related and
contextual factors, e.g. colonization status, serum antibody levels against S.
aureus alpha toxin [AT], the P. aeruginosa PcrV / Psl virulence factors.
Most important secondary objectives:
a) To develop a risk prediction model to quantify the risk of acquiring S.
aureus ICU pneumonia during ICU stay, by using a composite score of independent
risk factors identified through primary objective.
b) To develop a risk prediction model to quantify the risk of acquiring P.
aeruginosa ICU pneumonia during ICU stay, by using a composite score of
independent risk factors identified through primary objective.
For a comprehensive overview of all secondary and exporatory objectives, see
chapter 3 in the ASPIRE-ICU protocol.
Study design
ASPIRE-ICU is a prospective observational, multicenter, epidemiologic cohort
study nested within routine surveillance among ICU patients in Europe. A group
of 2000 eligible patients will be consented and enrolled as subjects into a
study cohort in which active sampling and more elaborate data collection will
take place. Throughout the whole study, fully anonymized, basic surveillance
data will be captured of all ICU patients as a part of routine practice and
will serve to assess ubiquity of the results across the groups.
Study burden and risks
This research in (mostly) incapacitated adults, is in our opinion associated
with a minimal risk and minimal burden for participating subjects. All study
procedures are of frequent occurrence on the ICU and are often already carried
out daily as part of routine care. Where possible, will these procedures be
combined with the routine taking of samples, ensuring that the subject is not
exposed to additional risk or burden.
Considering the disease that is studied in this research (ICU pneumonia) it is
not possible to do this research in a population with capacitated
(non-ventilated) subjects. Especially this patient group is at highest risk for
this infection, and a study that would only include capacitated ICU patients
would not give representative risk factors applying to the vulnerable,
incapacitated population.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
1. Participant is 18 years or older at the time of enrollment.
2. Participant is on mechanical ventilation at ICU admission, or is (expected to be) within 24 hours thereafter, based on investigator*s judgment.
3. Expected stay in ICU is 48 hours or longer based on investigator*s judgment.
4. SA colonization status is known within 72 hours after start of first episode of mechanical ventilation ICU admission and according to the result the patient qualifies for enrollment (see section 4.1).
5. Written informed consent from subject / legally accepted representative within 72 hours after start of first episode of mechanical ventilation.
Exclusion criteria
1. Previous participation as a subject in the study cohort of this study.
2. Simultaneous participation of the subject in any preventive experimental study into anti-staphylococcus or anti-pseudomonas aeruginosa interventions.
3. Expected death (moribund status) within 48h or ICU discharge of the participant within 24h, at the moment of informed consent.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02413242 |
| CCMO | NL51762.041.14 |