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

NCT01624181 | Completed

• 2 other identifiers: ZIM-KF2111207AK0DRKS00004178
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Lower Respiratory Tract Infection; Pneumonia

Keywords

ion mobility spectrometry; hospital-acquired pneumonia; microbiological investigation; intensive care

Outcome Measures

Primary Outcomes (2)

• 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).

• 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).

Secondary Outcomes (3)

• length of ICU stay

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

• 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.

• 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)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients will be recruited from two intensive care units of the university hospital.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

University Medical Center Göttingen

Göttingen, Lower Saxony, 37075, Germany

Location

Related Publications (2)

• Junger 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.

  PMID: 22327321 BACKGROUND

• Perl T, Junger 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.

  PMID: 21668516 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

aspiration samples from the respiratory system (tracheal secretion sample, BAL)

MeSH Terms

Conditions

Pneumonia; Healthcare-Associated Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Cross Infection; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Quintel, Prof. Dr.

  University of Göttingen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 8, 2012
• First Posted: June 20, 2012
• Study Start: June 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: January 10, 2013

Record last verified: 2013-01

Locations

DE (1)