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

NCT ID: NCT02568358

Last Updated: 2015-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lower Respiratory Tract and Lung Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Experimental Intervention: DNA-based testing of BAL fluid

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hannover Medical School

OTHER

Sponsor Role lead

Responsible Party

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Thomas Fuehner

PD Dr. med. Thomas Fühner

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jens Gottlieb, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Hannover Medical School

Central Contacts

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Nora Drick, MD

Role: CONTACT

0511 532 ext. 4601

Hoyer Susanne

Role: CONTACT

0511 532 ext. 4601

Other Identifiers

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LuTx_Mibi-DNA-1

Identifier Type: -

Identifier Source: org_study_id

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