Acute Lower Respiratory Tract InfectionNCT01858974
Fast Identification of Pathogen in the Setting of Pneumonia Using Multiplex PCR
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 infections of the lower respiratory tract, is possible through the use of Multiplex PCR technology - a method that allows on time detection of bacteria in medical specimen by identifying DNA sequences that are known to be… 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
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2013to Jan 2014
- 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
- 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 has been recruited for a interventional clinical trial
- 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 DNA Using Multiplex PCR as a Point of Care Diagnostic Tool in the Setting of Pneumonia
With this study the investigators want to determine, if a fast identification of germs, causing infections of the lower respiratory tract, is possible through the use of Multiplex PCR technology - a method that allows on time detection of bacteria in medical specimen by identifying DNA sequences that are known to be specific for the respective microbe. Therefore aspiration samples from the respiratory tracts of ventilated patients, which are suspected to develop such an infection, will be collected and analyzed by using a multiplex PCR (polymerase chain reaction) application situated on the intensive care unit. The investigators want to determine if Multiplex PCR diagnostic could be a faster alternative to conventional microbiological methods. The results of the Multiplex PCR analyses therefore will be compared with results of conventional microbiological methods.
Read the detailed description
In this clinical observational study it is to be investigated if Multiplex PCR analyses of clinical samples from ventilated critically ill patients could be a fast and accurate alternative to conventional microbiological diagnostic methods in the identification of human pathogenic microbes in the setting of pneumonia. Therefore aspiration samples from intubated and ventilated critically ill patients, which are suspected to develop such an infection, will be collected and analyzed by using a multiplex PCR application situated on the intensive care unit. The samples will be investigated for DNA sequences that are known to be specific for pneumonia causing microbes. Analyses will take place in a point of care setting and will be carried out by intensive care physicians. According to the standard protocols of our intensive care units, conventional microbiological investigations, including MALDI-TOF, will be carried out parallel to the Multiplex PCR analyses.
- Conditions
- Acute Lower Respiratory Tract Infection, Pneumonia
- Keywords
- multiplex PCR, MALDI-TOF, pneumonia, microbiological investigation, intensive care
- Medical subject headings
- Pneumonia
What is being measured
The primary outcome is the main question the study is designed to answer.
Time until pathogen identification through Multiplex PCR
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 (2)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Göttingen
- Sponsor type
- University, hospital or other
- Collaborators
- Curetis AG, Holzgerlingen, Germany
- Responsible party
- Principal investigator, Dr. med. Nils Kunze, University of Göttingen
- Investigators
- Michael Quintel, Prof. Dr., Study director, University of Göttingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01858974
- Sponsor's protocol ID
- ZARI-NK-2013-01
- Status last verified
- Feb 2014
- First submitted
- 16 May 2013
- Last updated
- 19 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Oosterheert JJ, van Loon AM, Schuurman R, Hoepelman AI, Hak E, Thijsen S, Nossent G, Schneider MM, Hustinx WM, Bonten MJ. Impact of rapid detection of viral and atypical bacterial pathogens by real-time polymerase chain reaction for patients with lower respiratory tract infection. Clin Infect Dis. 2005 Nov 15;41(10):1438-44. doi: 10.1086/497134. Epub 2005 Oct 13.
PubMed 16231254Caliendo AM. Multiplex PCR and emerging technologies for the detection of respiratory pathogens. Clin Infect Dis. 2011 May;52 Suppl 4(Suppl 4):S326-30. doi: 10.1093/cid/cir047.
PubMed 21460291Kunze N, Moerer O, Steinmetz N, Schulze MH, Quintel M, Perl T. Point-of-care multiplex PCR promises short turnaround times for microbial testing in hospital-acquired pneumonia--an observational pilot study in critical ill patients. Ann Clin Microbiol Antimicrob. 2015 Jun 13;14:33. doi: 10.1186/s12941-015-0091-3.
PubMed 26071191
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Microbes Through Detection of Pathogen Specific DNA Using Multiplex PCR as a Point of Care Diagnostic Tool in the Setting of Pneumonia
- ClinicalTrials.gov ID
- NCT01858974
- Acronym / sponsor ID
- ZARI-NK-2013-01
- Conditions
- Acute Lower Respiratory Tract Infection, Pneumonia
- Keywords
- multiplex PCR, MALDI-TOF, pneumonia, microbiological investigation, intensive care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of GöttingenUniversity, hospital or other
- Collaborators
- Curetis AG, Holzgerlingen, Germany
- Study start
- Jun 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 21 May 2013 (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 infections of the lower respiratory tract, is possible through the use of Multiplex PCR technology - a method that allows on time detection of bacteria in medical specimen by identifying DNA sequences that are known to be specific for the respective microbe. Therefore aspiration samples from the respiratory tracts of ventilated patients, which are suspected to develop such an infection, will be collected and analyzed by using a multiplex PCR (polymerase chain reaction) application situated on the intensive care unit. The investigators want to determine if Multiplex PCR diagnostic could be a faster alternative to conventional microbiological methods. The results of the Multiplex PCR analyses therefore will be compared with results of conventional microbiological methods.
Detailed description
In this clinical observational study it is to be investigated if Multiplex PCR analyses of clinical samples from ventilated critically ill patients could be a fast and accurate alternative to conventional microbiological diagnostic methods in the identification of human pathogenic microbes in the setting of pneumonia. Therefore aspiration samples from intubated and ventilated critically ill patients, which are suspected to develop such an infection, will be collected and analyzed by using a multiplex PCR application situated on the intensive care unit. The samples will be investigated for DNA sequences that are known to be specific for pneumonia causing microbes. Analyses will take place in a point of care setting and will be carried out by intensive care physicians. According to the standard protocols of our intensive care units, conventional microbiological investigations, including MALDI-TOF, will be carried out parallel to the Multiplex PCR 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 (1 listed)
- 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 (2 listed)
- patient has been recruited for a interventional clinical trial
- 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 Multiplex PCR
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.
2 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.
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 19 Feb 2014.
- Background: PubMed 16231254Oosterheert JJ, van Loon AM, Schuurman R, Hoepelman AI, Hak E, Thijsen S, Nossent G, Schneider MM, Hustinx WM, Bonten MJ. Impact of rapid detection of viral and atypical bacterial pathogens by real-time polymerase chain reaction for patients with lower respiratory tract infection. Clin Infect Dis. 2005 Nov 15;41(10):1438-44. doi: 10.1086/497134. Epub 2005 Oct 13.
- Background: PubMed 21460291Caliendo AM. Multiplex PCR and emerging technologies for the detection of respiratory pathogens. Clin Infect Dis. 2011 May;52 Suppl 4(Suppl 4):S326-30. doi: 10.1093/cid/cir047.
- Derived from this study: PubMed 26071191Kunze N, Moerer O, Steinmetz N, Schulze MH, Quintel M, Perl T. Point-of-care multiplex PCR promises short turnaround times for microbial testing in hospital-acquired pneumonia--an observational pilot study in critical ill patients. Ann Clin Microbiol Antimicrob. 2015 Jun 13;14:33. doi: 10.1186/s12941-015-0091-3.
- 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 1 inclusion and 2 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 19 Feb 2014. 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 Multiplex PCR (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 NCT01858974, which also lists 3 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 19 Feb 2014.