Acute Lower Respiratory Tract InfectionNCT01624181
Fast Identification of Pathogen in the Setting of Hospital-acquired Pneumonia Using Ion Mobility Spectrometry
An observational study of Acute Lower Respiratory Tract Infection and Pneumonia, run by University of Göttingen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Lower Respiratory Tract Infection, Pneumonia
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2012to Sep 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients will be recruited from two intensive care units of the university hospital.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Medical Center Göttingen
Göttingen, Lower Saxony, 37075
About this study
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
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.
Read the 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.
- Conditions
- Acute Lower Respiratory Tract Infection, Pneumonia
- Keywords
- ion mobility spectrometry, hospital-acquired pneumonia, microbiological investigation, intensive care
- Medical subject headings
- Pneumonia, Healthcare-Associated Pneumonia
What is being measured
The primary outcome is the main question the study is designed to answer.
Time until pathogen identification through MCC-IMS
time from sampling until the availability of the results.
Measured: 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.
Measured: 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
total LOS ICU
Measured: 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
Measured: 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.
Measured: Starts for study patients with the ICU admission and ends two days after the start of the initial antibiotic therapy. (up to 12 Months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Lower Respiratory Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Göttingen
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Economics and Technology, B&S Analytik GmbH, Dortmund, Germany, Universität Duisburg-Essen, Korean Institute for Science and Technology in Europe, Saarbrücken, Germany
- Responsible party
- Principal investigator, Dr. T. Perl, University of Göttingen
- Investigators
- Michael Quintel, Prof. Dr., Study director, University of Göttingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01624181
- Sponsor's protocol ID
- ZIM-KF2111207AK0
- Other IDs
- DRKS00004178
- Status last verified
- Jan 2013
- First submitted
- 8 Jun 2012
- Last updated
- 10 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22327321Perl 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.
PubMed 21668516
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01624181
- Acronym / sponsor ID
- ZIM-KF2111207AK0
- Conditions
- Acute Lower Respiratory Tract Infection, Pneumonia
- Keywords
- ion mobility spectrometry, hospital-acquired pneumonia, microbiological investigation, intensive care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of GöttingenUniversity, hospital or other
- Collaborators
- German Federal Ministry of Economics and Technology, B&S Analytik GmbH, Dortmund, Germany, Universität Duisburg-Essen, Korean Institute for Science and Technology in Europe, Saarbrücken, Germany
- Study start
- Jun 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 20 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients will be recruited from two intensive care units of the university hospital.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
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).
time from sampling until the availability of the results.
3 secondary outcomes
length of ICU stay
Time frame: time from ICU admission to ICU discharge of study patients (up to 12 months)
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.
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2013.
- Background: PubMed 22327321Junger 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.
- Background: PubMed 21668516Perl 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.
- Homepage of the center for anaesthesiology, emergency- and intensive care medicine of the university medical center GöttingenLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Quintel, Prof. Dr. study director
University of Göttingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lower Respiratory Tract Infection and Pneumonia, run by University of Göttingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01624181, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2013.