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

NCT02568358 | Unknown

• 1 other identifier: LuTx_Mibi-DNA-1
• Study Type: observational
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Lower Respiratory Tract and Lung Infections

Outcome Measures

Primary Outcomes (1)

• 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

  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

Interventions

Experimental Intervention: DNA-based testing of BAL fluid OTHER

DNA based testing needs 4.5 hours lab time in addition to standard testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• no informed consent

Sponsors & Collaborators

• Hannover Medical School: lead

Biospecimen

Retention: SAMPLES WITH DNA

Bronchoalveolar lavage

Study Officials

• Jens Gottlieb, Prof. Dr.

  Hannover Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nora Drick, MD

CONTACT

0511 532; drick.nora@mh-hannover.de

Hoyer Susanne

CONTACT

0511 532; hoyer.susanne@mh-hannover.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med. Thomas Fühner

Study Record Dates

• First Submitted: October 2, 2015
• First Posted: October 5, 2015
• Study Start: October 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: June 1, 2016
• Last Updated: October 5, 2015

Record last verified: 2015-10