Fast Identification of Pathogen in the Setting of Pneumonia Using Multiplex PCR

Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01858974
• Other study ID #: ZARI-NK-2013-01
• Status: Completed
• Phase: N/A
• First received: May 16, 2013
• Last updated: February 18, 2014
• Start date: June 2013
• Est. completion date: January 2014

Study information

• Verified date: February 2014
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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 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)

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 (2)

Lead Sponsor	Collaborator
University of Göttingen	Curetis AG, Holzgerlingen, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Caliendo AM. Multiplex PCR and emerging technologies for the detection of respiratory pathogens. Clin Infect Dis. 2011 May;52 Suppl 4:S326-30. doi: 10.1093/cid/cir047. Review. — View Citation

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. Epub 2005 Oct 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time until pathogen identification through Multiplex PCR	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

External Links

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