Advanced Understanding of Staphylococcus Aureus and Pseudomonas Aeruginosa Infections in EuRopE - ICU

NCT02413242 | Completed

• 1 other identifier: NL51762.041.14
• Study Type: observational
• Target: 2,031
• Locations: 1 country
• Sites: 1

Brief Summary

Intensive Care Unit (ICU) acquired pneumonia, including ventilator-associated pneumonia, is a frequently occurring health-care associated infection, 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.

Conditions

Pneumonia; Pneumonia, Ventilator-Associated; Nosocomial Pneumonia

Keywords

S. aureus; P. aeruginosa; Colonization; Pneumonia; ICU

Outcome Measures

Primary Outcomes (2)

• Incidence of S. aureus ICU pneumonia

  date of ICF until ICU discharge (on average 7 days after ICF)

• Incidence of P. aeruginosa ICU pneumonia

  date of ICF until ICU discharge (on average 7 days after ICF)

Secondary Outcomes (13)

• Prevalence of S. aureus / P. aeruginosa colonization

  at ICU admission

• Incidence of all cause ICU pneumonia

  date of ICF until ICU discharge (on average 7 days after ICF)

• Incidence of S. aureus ICU pneumonia stratified by MRSA vs. MSSA

  date of ICF until ICU discharge (on average 7 days after ICF)

• Incidence of P. aeruginosa ICU pneumonia stratified by MDR-PA vs. S-PA

  date of ICF until ICU discharge (on average 7 days after ICF)

• Incidence of ICU bacteremia per etiologic agent (in case of S. aureus and/or P. aeruginosa and for all clinically relevant other pathogens)

  date of ICF until ICU discharge (on average 7 days after ICF)

Other Outcomes (6)

• Magnitude of healthcare utilization as measured by: a. Duration of ICU stay including readmissions

  day of ICU admission until day 30 after ICU discharge

• Magnitude of healthcare utilization as measured by: b. Days on mechanical ventilation

  day of ICU admission until ICU discharge (on average 9 days after ICU admission)

• Magnitude of healthcare utilization as measured by: c. Days of antibiotic usage

  day of ICU admission until ICU discharge (on average 9 days after ICU admission)

Study Arms (2)

ICU subjects, S. aureus+ at ICU admission

Adult ICU patients, with a positive colonization status for S. aureus at ICU admission, who are mechanically ventilated within 24 hours of ICU admission and have an expected length of stay of 48h or more. Colonization status will be measured at ICU admission using a nose swab and an ETA (or sputum/throat if unavailable). Positivity of either of the two qualifies the patient to be enrolled as a subject in this group.

Other: Various observed exposure(s) of interest

ICU subjects, S. aureus- at ICU admission

Adult ICU patients, with a negative colonization status for S. aureus at ICU admission, who are mechanically ventilated within 24 hours of ICU admission and have an expected length of stay of 48h or more. Colonization status will be measured at ICU admission using a nose swab and an ETA (or sputum/throat if unavailable). Negativity of both qualifies the patient to be enrolled as a subject in this group.

Other: Various observed exposure(s) of interest

Interventions

Various observed exposure(s) of interest OTHER

A risk prediction model will be developed to assess which risk factors are associated with the development of ICU pneumonia during ICU stay

ICU subjects, S. aureus+ at ICU admission; ICU subjects, S. aureus- at ICU admission

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

ICU patients in approximately 30 sites in 6-12 European countries will be selected based on eligibility criteria that are described below. Inclusion will be based on S. aureus (SA) colonization status at ICU admission (ratio 1:1). These subjects will be followed through their ICU stay for assessment of the primary outcomes.

You may qualify if:

• Participant is 18 years or older at the time of enrollment.
• Participant is on mechanical ventilation at ICU admission, or is (expected to be) within 24 hours thereafter, based on investigator's judgment.
• Expected stay in ICU is 48 hours or longer based on investigator's judgment.
• SA colonization status is known within 72 hours after start of first episode of mechanical ventilation and according to the result, the patient qualifies for enrollment.
• Written informed consent from subject / legally accepted representative within 72 hours after start of first episode of mechanical ventilation.

You may not qualify if:

• Previous participation as a subject in the study cohort of this study.
• Simultaneous participation of the subject in any preventive experimental study into anti-staphylococcus or anti-pseudomonas aeruginosa interventions.
• Expected death (moribund status) within 48h, or ICU discharge of the participant within 24h, at the moment of informed consent.

Sponsors & Collaborators

• Jan Kluytmans: lead
• MedImmune LLC: collaborator
• Universiteit Antwerpen: collaborator

Study Sites (1)

UMC Utrecht

Utrecht, Netherlands

Location

Related Publications (2)

• van Engelen TSR, Reijnders TDY, Paling FP, Bonten MJM, Timbermont L, Malhotra-Kumar S, Kluytmans JAJW, Peters-Sengers H, van der Poll T; ASPIRE-I. C. U. Study Team. Plasma protein biomarkers reflective of the host response in patients developing Intensive Care Unit-acquired pneumonia. Crit Care. 2023 Jul 6;27(1):269. doi: 10.1186/s13054-023-04536-0.

  PMID: 37415223 DERIVED

• Paling FP, Troeman DPR, Wolkewitz M, Kalyani R, Prins DR, Weber S, Lammens C, Timbermont L, Goossens H, Malhotra-Kumar S, Sifakis F, Bonten MJM, Kluytmans JAJW. Rationale and design of ASPIRE-ICU: a prospective cohort study on the incidence and predictors of Staphylococcus aureus and Pseudomonas aeruginosa pneumonia in the ICU. BMC Infect Dis. 2017 Sep 25;17(1):643. doi: 10.1186/s12879-017-2739-4.

  PMID: 28946849 DERIVED

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITHOUT DNA

* Microbiological samples: * Nose swabs - at day of informed consent form (ICF), day 4, day 7. * Peri-anal swabs - at day of ICF, day 4, day 7, then twice weekly until day 30. * Lower respiratory tract (LRT) sample - at day of ICF, day 4, day 7, then twice weekly until day 30, day of ICU pneumonia, day 7 after ICU pneumonia. The LRT sample can be defined as the collection of an endotracheal aspirate (ETA). If an ETA cannot be collected, a sputum sample may be taken. * Broncho alveolar lavage - If available through clinical procedures, BAL specimens will be collected for study purposes. * Blood samples \* Blood samples will be taken at day of ICF, day 7 and day 30 or day of ICU discharge (whichever occurs first), day of ICU pneumonia, day 7 after ICU pneumonia and day 30 after ICU pneumonia.

MeSH Terms

Conditions

Pneumonia; Pneumonia, Ventilator-Associated; Healthcare-Associated Pneumonia; Staphylococcal Infections

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Cross Infection; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Study Officials

• Jan A.J.W. Kluytmans, Prof.

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 1, 2015
• First Posted: April 9, 2015
• Study Start: April 1, 2015
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: May 8, 2019

Record last verified: 2019-05

Locations

NL (1)