Fast Identification of Pathogen in the Setting of Hospital-acquired Pneumonia Using Ion Mobility Spectrometry

University of Göttingen24 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Acute Lower Respiratory Tract Infection Pneumonia

Medical Language ↔ Plain English

Inclusion Criteria: * patient is at the hospital for more than 48 hours * patient is intubated and mechanically ventilated * clinical suspicion for an infection of the lower respiratory tract has been raised and decision for microbiological investigation of respiratory aspirate was made Exclusion Criteria: * patient is at the hospital for less than 48 hours * patient has been recruited for another clinical study * suspicion for an infection with a germ belonging to risk class 3 and 4 according to the german law (BioStoffV and TRBA, e.g. Mycobacterium tuberculosis)

Outcomes

Primary Outcomes

Time until pathogen identification through MCC-IMS

time from sampling until the availability of the results.

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).

time until pathogen identification through conventional microbiological diagnostic methods

time from sampling until the availability of the results.

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).

Secondary Outcomes

length of ICU stay

total LOS ICU

Time frame: time from ICU admission to ICU discharge of study patients (up to 12 months)

Type and dosage of administered antibiotic therapy

name and dosage of the antibiotic therapeutic agents used to threat the infection

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.

morbidity

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.

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)