Viewing Study NCT01624181



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Last Modification Date: 2024-10-26 @ 10:52 AM
Study NCT ID: NCT01624181
Status: COMPLETED
Last Update Posted: 2013-01-10
First Post: 2012-06-08

Brief Title: Fast Identification of Pathogen in the Setting of Hospital-acquired Pneumonia Using Ion Mobility Spectrometry
Sponsor: University of Göttingen
Organization: University of Göttingen

Study Overview

Official Title: Identification of Microbes Through Detection of Pathogen Specific Volatile Compound Patterns Using Multi-capillary Column Coupled Ion Mobility Spectrometry MCC-IMS in the Setting of Hospital-acquired Pneumonia
Status: COMPLETED
Status Verified Date: 2013-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: With this study the investigators want to determine if a fast identification of germs causing hospital-acquired infections of the lower respiratory tract is possible through the use of MCC-IMS technology - a method that allows on time detection and identification of very small amounts of substances in gas samples Therefore aspiration samples from the respiratory tracts of ventilated patients which are suspected to develop such an infection will be collected cultivated and analyzed by MCC-IMS The investigators want to determine if MCC-IMS diagnostic could be a faster alternative to conventional microbiological methods The results of the MCC-IMS analyses therefore will be compared with results of conventional microbiological methods
Detailed Description: In this clinical feasibility study it is to be investigated if MCC-IMS analyses over clinical samples from ventilated critically ill patients could be a fast and secure alternative to conventional microbiological diagnostic methods in the identification of human pathogenic microbes in the setting of hospital-acquired pneumonia Therefore aspiration samples from intubated and ventilated critically ill patients which are suspected to develop such an infection will be collected and cultivated for a short period of time The headspace over these cultures will be analyzed using MCC-IMS - a technology that allows on time detection and identification of very small amounts of substances in complex and humid gas samples Conventional microbiological investigations including MALDI-TOF will be carried out parallel to the MCC-IMS analyses

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
DRKS00004178 REGISTRY German Clinical Trials Register None