Lower Respiratory Tract and Lung InfectionsNCT02568358
DNA-based Testing in BAL of Lung Transplant Recipients With Suspected Non-viral Lower Respiratory Tract Infection
An observational study of Lower Respiratory Tract and Lung Infections, run by Hannover Medical School.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Respiratory Tract and Lung Infections
- What is being tested?
- Experimental Intervention: DNA-based testing of BAL fluid
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Lung transplant recipients with suspected non-viral lower respiratory tract infection
Who may be able to join
- 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
Show all 9Show fewer
- purulent (yellow or greenish) sputum
- CRP of 30 mg/l or above
- PCT of 0,5 µg/l or above
Who cannot join
- no informed consent
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Being tested
- Experimental Intervention: DNA-based testing of BAL fluid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Intervention: DNA-based testing of BAL fluidOther
DNA based testing needs 4.5 hours lab time in addition to standard testing
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionApr 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Respiratory Tract and Lung InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Fuehner, Hannover Medical School
- Investigators
- Jens Gottlieb, Prof. Dr., Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02568358
- Sponsor's protocol ID
- LuTx_Mibi-DNA-1
- Status last verified
- Oct 2015
- First submitted
- 2 Oct 2015
- Last updated
- 5 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DNA-based Testing in BAL of Lung Transplant Recipients With Suspected Non-viral Lower Respiratory Tract Infection
- ClinicalTrials.gov ID
- NCT02568358
- Acronym / sponsor ID
- LuTx_Mibi-DNA-1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 5 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lung transplant recipients with suspected non-viral lower respiratory tract infection
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (1 listed)
- no informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental Intervention: DNA-based testing of BAL fluidDNA based testing needs 4.5 hours lab time in addition to standard testing | Other | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Gottlieb, Prof. Dr. principal investigator
Hannover Medical School
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Respiratory Tract and Lung Infections, run by Hannover Medical School.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nora Drick, MD (0511 532 ext. 4601, drick.nora@mh-hannover.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2015.