Fast Identification of Pathogen in the Setting of Hospital-acquired Pneumonia Using Ion Mobility Spectrometry
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.
Acute Lower Respiratory Tract Infection
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|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|
- Time until pathogen identification through MCC-IMS [ Time Frame: Up to 24 hours after sampling. Sampling (as an iclusion criterion) can be necessary anytime along the ICU stay of the patient (up to 12 months). ] [ Designated as safety issue: No ]time from sampling until the availability of the results.
- time until pathogen identification through conventional microbiological diagnostic methods [ Time Frame: Up to 5 days after Sampling. Sampling (as an iclusion criterion) can be necessary anytime along the ICU stay of the patient (up to 12 months). ] [ Designated as safety issue: No ]time from sampling until the availability of the results.
- length of ICU stay [ Time Frame: time from ICU admission to ICU discharge of study patients (up to 12 months) ] [ Designated as safety issue: No ]total LOS ICU
- Type and dosage of administered antibiotic therapy [ Time Frame: approximately 5 days. Starting with the day the samples are taken. Ending with the day on which the results microbiological test are made avaiable. ] [ Designated as safety issue: No ]name and dosage of the antibiotic therapeutic agents used to threat the infection
- morbidity [ Time Frame: Starts for study patients with the ICU admission and ends two days after the start of the initial antibiotic therapy. (up to 12 Months) ] [ Designated as safety issue: No ]morbidity of the critical ill patient at ICU admission, at the time of sampling and after two days of antibiotic therapy using the SAPS II scoring system.
Biospecimen Retention: Samples Without DNA
aspiration samples from the respiratory system (tracheal secretion sample, BAL)
|Study Start Date:||June 2012|
|Study Completion Date:||September 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01624181
|University Medical Center Göttingen|
|Göttingen, Niedersachsen, Germany, 37075|
|Study Director:||Michael Quintel, Prof. Dr.||University of Göttingen|