Direct Molecular Characterization of Bacteria From ICU and From the REHAB
1 other identifier
observational
971
1 country
2
Brief Summary
Investigators aim to directly investigate the molecular properties of bacteria from tracheal and urinary samples routinely taken in intensive care units (ICU) patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2018
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2018
CompletedFirst Submitted
Initial submission to the registry
February 14, 2018
CompletedFirst Posted
Study publicly available on registry
March 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 27, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 27, 2021
CompletedFebruary 17, 2021
February 1, 2021
3 years
February 14, 2018
February 16, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Abundance of pathogen proteins
Determine the abundance of pathogen proteins in the samples and in in vitro cultures of the same pathogen strains using cutting-edge ultra-sensitive proteomics approaches (Parallel reaction monitoring, PRM, Sequential Windowed Acquisition of All Theoretical Fragment Ion Mass Spectra, SWATH-MS). Data will be analyzed using dedicated mass spectrometry and proteomics packages using parametric and non-parametric statistics (false discovery rate determination based on decoy databases; t-tests of log-transformed abundance data with Benjamin-Hochberg corrections for multiple testing, normal distribution of the data will be evaluated by Kolmogorov-Smirnov test).
once during study (February 2018 until June 2020) but no fixed timepoint
Eligibility Criteria
All in ICU-patients and REHAB-Basel patients with residual material from tracheal or urinary samples taken for routine diagnostics of patients with suspected bacterial infection will be included.
You may qualify if:
- confirmed infection of lung or urine by one or several members of a defined set of bacterial pathogens (Pseudomonas aeruginosa, E. coli, Klebsiella spp., Serratia marcescens, Enterobacter spp., Acinetobacter baumannii, Staphylococcus aureus, Streptococcus pneumonia
You may not qualify if:
- Proof of a refusal to the general research consent
- No detected bacteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Division of Infectious Diseas and Hospital Epidemiology
Basel, 4031, Switzerland
REHAB Basel, Klinik für Neurorehabilitation und Paraplegiologie
Basel, 4055, Switzerland
Biospecimen
bacteria from tracheal and urinary samples routinely taken in intensive care units (ICU) and REHAB-Basel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nina Khanna, Prof. Dr. MD
University Hospital, Basel, Switzerland
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2018
First Posted
March 23, 2018
Study Start
February 1, 2018
Primary Completion
January 27, 2021
Study Completion
January 27, 2021
Last Updated
February 17, 2021
Record last verified: 2021-02