PneumoniaLRT55NCT01922024

Detection of Microorganisms and Antibiotic Resistance Genes Using the Curetis Unyvero LRT55 Application

An observational study of Pneumonia, run by Curetis GmbH at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The Curetis Unyvero LRT55 Application is intended to detect and to identify genes of 21 microorganisms and 19 genes associated with antibiotic resistance in 4 hours. In this study, the performance of the Unyvero LRT55 Application shall be tested under clinical conditions and compared to (1) a composite reference… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pneumonia
What is being tested?: LRT55 Testing
Type of treatment: Medical device
How many people: 2,124 participants
Where: 9 sitesUnited States
Study dates: Jun 2015to Nov 2016
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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: Suspicion of lower respiratory tract infection in hospitalized subjects.

Who may be able to join

Hospitalized subjects with suspicion of lower respiratory tract infection
Age at least 18 years
Available surplus respiratory aspirate or bronchial lavage sample

Who cannot join

Out-patient (ambulatory patient)
Known infection with HIV, HBV or tuberculosis

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Summa Health System
Akron, Ohio, 44304
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Northwestern Memorial Hospital
Chicago, Illinois, 60611
University of California Los Angeles (UCLA)
Los Angeles, California, 90049
Columbia Universiy Medical Center / New York-Presbyterian Hosp.
New York, New York, 10032
Mayo Clinic
Rochester, Minnesota, 55901
Rochester Medical Center
Rochester, New York, 14642
William Beaumont Hospital
Royal Oak, Michigan, 48073
University of Washington
Seattle, Washington, 98195

Other trials in United States

About this study

Official title: Detection of Microorganisms and Antibiotic Resistance Genes in Lower Respiratory Tract (LRT) Samples Using the Curetis Unyvero LRT55 Application

The Curetis Unyvero LRT55 Application is intended to detect and to identify genes of 21 microorganisms and 19 genes associated with antibiotic resistance in 4 hours.

In this study, the performance of the Unyvero LRT55 Application shall be tested under clinical conditions and compared to (1) a composite reference method (for non-atypical or cultured microorganisms) or (2) a molecular PCR based reference method for the 3 atypical microorganisms Chlamydophila pneumoniae, Legionella pneumoniae, and Pneumocystis jirovecii, and for resistance genes.

PCR amplifications are followed by bi-directional sequencing, including comparison of the test results Time to result will be compared for the Unyvero LRT55 Application and standard-of care.

Read the detailed description

This is a non-interventional, controlled, non-randomized multicenter clinical study that compares a new diagnostic device, the Unyvero LRT55 Application (based on molecular diagnostic methods) to either (1) a composite reference method (for non-atypical microorganisms), (2) a composite PCR-based method for 3 atypical microorganisms or (3) a PCR-based reference method for resistance genes.

The study will use leftover lower respiratory tract samples taken from subjects suspected with lower respiratory tract infections: (a) Specimens taken prospectively for standard-of-care (i.e. microbiology testing) from hospitalized subjects. (b) Banked specimens for rare microorganisms.

As the device is under investigation, the test results provided by the Unyvero LRT55 Application will not be made available to the treating physician and therefore will not be used for diagnosis, treatment or other management decisions.

Conditions: Pneumonia
Being tested: LRT55 Testing
Medical subject headings: Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LRT55 TestingDevice
Testing on the Unyvero LRT55

Study groups in NCT01922024
Study group	Role	What they receive
Prospective Fresh Clinical Specimens		Patients with suspicion of lower respiratory tract infection (pneumonia), samples tested with Unyvero LRT 55 cartridge and results compared against composite (comparator) which is based on routine clinical microbiology and a second PCR test Receives: Device: LRT55 Testing
Retrospective Frozen Clinical Specimens		Patients with suspicion of lower respiratory tract infection (pneumonia), samples tested with Unyvero LRT 55 cartridge and results compared against routine clinical microbiology Receives: Device: LRT55 Testing

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinical Sensitivity and Specificity for Microorganism Detection as Compared to Routine Microbiology and Other Reference Methods Including PCR and Sequencing
Sensitivity for microorganism detection will be determined against the respective reference method consisting of standard procedure and/or a reference method based on PCR and bi-directional sequencing using alternative primers. Sensitivity for non-atypical microorganism detection will thus be determined if at least 1 out of 2 reference methods have identified microorganisms that are covered by the panel of the investigational IVD. Results will further be analyzed against standard of-care alone, as well as against composite comparator. Sensitivity for atypical microorganism detection will be determined against PCR with alternative primers as reference method. Specificity for microorganism detection will be determined in all samples included in the trial. Individual specificities will be calculated for the detection of the respiratory microorganisms analyzed by the investigational IVD compared to the microorganisms reference method.
Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2015Nov 2016

First posted14 Aug 2013 (estimated)
Study startJun 2015
Primary completionNov 2016
Study completionNov 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PneumoniaStudies 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: 2,124 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01922024
Sponsor's protocol ID: CURETIS LRT55 Study - V 6.0
Acronym: LRT55
Status last verified: Feb 2019
First submitted: 7 Aug 2013
Last updated: 5 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pneumonia trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Detection of Microorganisms and Antibiotic Resistance Genes in Lower Respiratory Tract (LRT) Samples Using the Curetis Unyvero LRT55 Application
ClinicalTrials.gov ID: NCT01922024
Acronym / sponsor ID: LRT55 / CURETIS LRT55 Study - V 6.0
Conditions: Pneumonia
Study type: Observational
Recruitment status: Completed
Enrolment: 2,124 participants (actual)
Lead sponsor: Curetis GmbHIndustry (pharma, biotech, devices)
Collaborators: Global BioClinical
Study start: Jun 2015
Primary completion: Nov 2016 (actual)
Study completion: Nov 2016 (actual)
First posted: 14 Aug 2013 (estimated)
Results: Posted 5 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The Curetis Unyvero LRT55 Application is intended to detect and to identify genes of 21 microorganisms and 19 genes associated with antibiotic resistance in 4 hours.

PCR amplifications are followed by bi-directional sequencing, including comparison of the test results Time to result will be compared for the Unyvero LRT55 Application and standard-of care.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Prospective Fresh Clinical Specimens	–	Device: LRT55 TestingPatients with suspicion of lower respiratory tract infection (pneumonia), samples tested with Unyvero LRT 55 cartridge and results compared against composite (comparator) which is based on routine clinical microbiology and a second PCR test
Retrospective Frozen Clinical Specimens	–	Device: LRT55 TestingPatients with suspicion of lower respiratory tract infection (pneumonia), samples tested with Unyvero LRT 55 cartridge and results compared against routine clinical microbiology

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Suspicion of lower respiratory tract infection in hospitalized subjects.

Key inclusion criteria (3 listed)

Hospitalized subjects with suspicion of lower respiratory tract infection
Age at least 18 years
Available surplus respiratory aspirate or bronchial lavage sample

Key exclusion criteria (2 listed)

Out-patient (ambulatory patient)
Known infection with HIV, HBV or tuberculosis

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
LRT55 TestingTesting on the Unyvero LRT55	Device	Prospective Fresh Clinical Specimens, Retrospective Frozen Clinical Specimens

Primary outcome

Clinical Sensitivity and Specificity for Microorganism Detection as Compared to Routine Microbiology and Other Reference Methods Including PCR and Sequencing
Time frame: Up to 12 months
Sensitivity for microorganism detection will be determined against the respective reference method consisting of standard procedure and/or a reference method based on PCR and bi-directional sequencing using alternative primers. Sensitivity for non-atypical microorganism detection will thus be determined if at least 1 out of 2 reference methods have identified microorganisms that are covered by the panel of the investigational IVD. Results will further be analyzed against standard of-care alone, as well as against composite comparator. Sensitivity for atypical microorganism detection will be determined against PCR with alternative primers as reference method. Specificity for microorganism detection will be determined in all samples included in the trial. Individual specificities will be calculated for the detection of the respiratory microorganisms analyzed by the investigational IVD compared to the microorganisms reference method.

Results and safety

Results posted to the registry on 5 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Prospective Fresh Clinical Specimens	1,653	1,653
Retrospective Frozen Clinical Specimens	471	471

Primary outcome: Clinical Sensitivity and Specificity for Microorganism Detection as Compared to Routine Microbiology and Other Reference Methods Including PCR and Sequencing

Time frame: Up to 12 months. Mean (95% Confidence Interval). Unit: Percentage

Measure	Prospective Fresh Clinical Specimens n = 1653	Retrospective Frozen Clinical Specimens n = 471
Sensitivity - Pathogen Detection	91.4 (91.4 to 91.4)	91.4 (91.4 to 91.4)
Specificity- Pathogen Detection	99.5 (99.5 to 99.5)	99.5 (99.5 to 99.5)
Sensitivity - Restistance Marker Detection	89.9 (89.9 to 89.9)	89.9 (89.9 to 89.9)
Specificity - Resistance Marker Detection	99.3 (99.3 to 99.3)	99.3 (99.3 to 99.3)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Prospective Fresh Clinical Specimens	0 of 0	0 of 0	Not reported
Retrospective Frozen Clinical Specimens	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Johannes Bacher study director

Curetis GmbH

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Pneumonia, run by Curetis GmbH at 9 sites in United States.

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 3 inclusion and 2 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: finished, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 5 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Sensitivity and Specificity for Microorganism Detection as Compared to Routine Microbiology and Other Reference Methods Including PCR and Sequencing (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01922024.

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 Mar 2019.