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

Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01624181
• Other study ID #: ZIM-KF2111207AK0
• Secondary ID: DRKS00004178
• Status: Completed
• Phase: N/A
• First received: June 8, 2012
• Last updated: January 9, 2013
• Start date: June 2012
• Est. completion date: September 2012

Study information

• Verified date: January 2013
• Source: University of Göttingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Lower Respiratory Tract Infection
• Pneumonia
• Respiratory Tract Infections

Locations

Country	Name	City	State
Germany	University Medical Center Göttingen	Göttingen	Niedersachsen

Sponsors (5)

Lead Sponsor	Collaborator
University of Göttingen	B&S Analytik GmbH, Dortmund, Germany, German Federal Ministry of Economics and Technology, Korean Institute for Science and Technology in Europe, Saarbrücken, Germany, Universität Duisburg-Essen

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Jünger M, Vautz W, Kuhns M, Hofmann L, Ulbricht S, Baumbach JI, Quintel M, Perl T. Ion mobility spectrometry for microbial volatile organic compounds: a new identification tool for human pathogenic bacteria. Appl Microbiol Biotechnol. 2012 Mar;93(6):2603-14. doi: 10.1007/s00253-012-3924-4. Epub 2012 Feb 12. — View Citation

Perl T, Jünger M, Vautz W, Nolte J, Kuhns M, Borg-von Zepelin M, Quintel M. Detection of characteristic metabolites of Aspergillus fumigatus and Candida species using ion mobility spectrometry-metabolic profiling by volatile organic compounds. Mycoses. 2011 Nov;54(6):e828-37. doi: 10.1111/j.1439-0507.2011.02037.x. Epub 2011 Jun 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time until pathogen identification through MCC-IMS	time from sampling until the availability of the results.	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).	No
Primary	time until pathogen identification through conventional microbiological diagnostic methods	time from sampling until the availability of the results.	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).	No
Secondary	length of ICU stay	total LOS ICU	time from ICU admission to ICU discharge of study patients (up to 12 months)	No
Secondary	Type and dosage of administered antibiotic therapy	name and dosage of the antibiotic therapeutic agents used to threat the infection	approximately 5 days. Starting with the day the samples are taken. Ending with the day on which the results microbiological test are made avaiable.	No
Secondary	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.	Starts for study patients with the ICU admission and ends two days after the start of the initial antibiotic therapy. (up to 12 Months)	No

External Links

•   Homepage of the center for anaesthesiology, emergency- and intensive care medicine of the university medical center Göttingen