DNA-based Testing in BAL of Lung Transplant Recipients With Suspected Non-viral Lower Respiratory Tract Infection

October 2, 2015 updated by: Thomas Fuehner, Hannover Medical School

Lung transplantation (LTx) , DNA-based testing.

Performance of DNA-based testing of bacterial and fungal pathogens in comparison to standard testing.

Experimental intervention: DNA-based testing of BAL fluid.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Cohen's kappa of any pathogen isolation by DNA-based testing vs. standard cultures in comparison to the final diagnosis of non-viral lower respiratory tract infection.

Study Type

Observational

Enrollment (Anticipated)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Lung transplant recipients with suspected non-viral lower respiratory tract infection

Description

Inclusion Criteria:

  • patients after lung transplantation (single, double or combined)
  • suspicion of non-viral lower respiratory tract infection as defined by at least 2 out of
  • new onset of malaise
  • new or progressive pulmonary infiltrate
  • hypoxemia (SpO2/SaO2 <92% or need for oxygen)
  • temperature of 38 o C or above within 7 days
  • purulent (yellow or greenish) sputum
  • CRP of 30 mg/l or above
  • PCT of 0,5 µg/l or above

Exclusion Criteria:

  • no informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cohen's kappa of any pathogen isolation by DNA-based testing vs. standard cultures in comparison to the final diagnosis of non-viral lower respiratory tract infection
Time Frame: 6 month
Cohen's kappa measures the agreement between methods and the final clinical diagnosis. Both methods (DNA-based testing and standard cultures) will result in isolation of a non-viral pathogen or no isolation of a pathogen. A final clinical diagnosis will classify patients clinically in two categories as non-viral lower respiratory tract infection or no non-viral lower respiratory tract infection usually made 48-72 hours made after sampling. Cohen's kappa will be compared between the two methods.
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hannover Medical School

Investigators

  • Principal Investigator: Jens Gottlieb, Prof. Dr., Hannover Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

April 1, 2016

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

October 2, 2015

First Submitted That Met QC Criteria

October 2, 2015

First Posted (Estimate)

October 5, 2015

Study Record Updates

Last Update Posted (Estimate)

October 5, 2015

Last Update Submitted That Met QC Criteria

October 2, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LuTx_Mibi-DNA-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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