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

Sponsor

University of Göttingen (Other)

Overall Status

Completed

CT.gov ID

NCT01624181

Collaborator

German Federal Ministry of Economics and Technology (Other), B&S Analytik GmbH, Dortmund, Germany (Other), Universität Duisburg-Essen (Other), Korean Institute for Science and Technology in Europe, Saarbrücken, Germany (Other)

Enrollment

Location

Duration (Months)

7.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Lower Respiratory Tract Infection Pneumonia

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 Design

Study Type:

Observational

Actual Enrollment :

24 participants

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

Study Start Date :

Jun 1, 2012

Actual Primary Completion Date :

Sep 1, 2012

Actual Study Completion Date :

Sep 1, 2012

Outcome Measures

Primary Outcome Measures

Time until pathogen identification through MCC-IMS [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 from sampling until the availability of the results.
time until pathogen identification through conventional microbiological diagnostic methods [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).]
time from sampling until the availability of the results.

Secondary Outcome Measures

length of ICU stay [time from ICU admission to ICU discharge of study patients (up to 12 months)]
total LOS ICU
Type and dosage of administered antibiotic therapy [approximately 5 days. Starting with the day the samples are taken. Ending with the day on which the results microbiological test are made avaiable.]
name and dosage of the antibiotic therapeutic agents used to threat the infection
morbidity [Starts for study patients with the ICU admission and ends two days after the start of the initial antibiotic therapy. (up to 12 Months)]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)