Fast Identification of Pathogen in the Setting of Pneumonia Using

Status Completed

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.

Clinical Trial 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

Related Conditions & MeSH terms

Acute Lower Respiratory Tract Infection
Pneumonia
Respiratory Tract Infections

Clinical Trial Details

NCT number	NCT01858974
Study type	Observational
Source	University of Göttingen
Contact
Status	Completed
Phase	N/A
Start date	June 2013
Completion date	January 2014

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms