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

NCT01858974 | Completed

• 1 other identifier: ZARI-NK-2013-01
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Lower Respiratory Tract Infection; Pneumonia

Keywords

multiplex PCR; MALDI-TOF; pneumonia; microbiological investigation; intensive care

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 (2)

• 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.

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:

• 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 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)

Sponsors & Collaborators

• University of Göttingen: lead
• Curetis AG, Holzgerlingen, Germany: collaborator

Study Sites (1)

University Medical Center Göttingen

Göttingen, Lower Saxony, 37075, Germany

Location

Related Publications (3)

• 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.

  PMID: 16231254 BACKGROUND

• Caliendo 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.

  PMID: 21460291 BACKGROUND

• Kunze 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.

  PMID: 26071191 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

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: May 16, 2013
• First Posted: May 21, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2014
• Last Updated: February 19, 2014

Record last verified: 2014-02

Locations

DE (1)