Trial Outcomes & Findings for Detection of Microorganisms and Antibiotic Resistance Genes Using the Curetis Unyvero LRT55 Application (NCT NCT01922024)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

2124 participants

Primary outcome timeframe

Up to 12 months

Results posted on

2019-03-05

Participant Flow

Participant milestones

Participant milestones
Measure	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 LRT55 Testing: Testing on the Unyvero LRT55	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 LRT55 Testing: Testing on the Unyvero LRT55
Overall Study STARTED	1653	471
Overall Study COMPLETED	1653	471
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prospective Fresh Clinical Specimens n=1653 Participants 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 LRT55 Testing: Testing on the Unyvero LRT55	Retrospective Frozen Clinical Specimens n=471 Participants Patients with suspicion of lower respiratory tract infection (pneumonia), samples tested with Unyvero LRT 55 cartridge and results compared against routine clinical microbiology LRT55 Testing: Testing on the Unyvero LRT55	Total n=2124 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	827 Participants n=5 Participants	186 Participants n=7 Participants	1013 Participants n=5 Participants
Age, Categorical >=65 years	826 Participants n=5 Participants	285 Participants n=7 Participants	1111 Participants n=5 Participants
Sex: Female, Male Female	665 Participants n=5 Participants	182 Participants n=7 Participants	847 Participants n=5 Participants
Sex: Female, Male Male	988 Participants n=5 Participants	289 Participants n=7 Participants	1277 Participants n=5 Participants
Region of Enrollment United States	1653 participants n=5 Participants	471 participants n=7 Participants	2124 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Prospective Fresh Clinical Specimens n=1653 Participants 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 LRT55 Testing: Testing on the Unyvero LRT55 an overall weighted average sensitivity of 91.4% for detection of panel pathogens an overall weighted average specificity of 99.5% for detection of panel pathogens an overall weighted average sensitivity of 89.9 % for detection of resistance markers an overall weighted average specificity of 99.3 % for detection of resistance markers	Retrospective Frozen Clinical Specimens n=471 Participants Patients with suspicion of lower respiratory tract infection (pneumonia), samples tested with Unyvero LRT 55 cartridge and results compared against routine clinical microbiology LRT55 Testing: Testing on the Unyvero LRT55 an overall weighted average sensitivity of 91.4% for detection of panel pathogens an overall weighted average specificity of 99.5% for detection of panel pathogens an overall weighted average sensitivity of 89.9 % for detection of resistance markers an overall weighted average specificity of 99.3 % for detection of resistance markers
Clinical Sensitivity and Specificity for Microorganism Detection as Compared to Routine Microbiology and Other Reference Methods Including PCR and Sequencing Specificity - Resistance Marker Detection	99.3 Percentage Interval 99.3 to 99.3	99.3 Percentage Interval 99.3 to 99.3
Clinical Sensitivity and Specificity for Microorganism Detection as Compared to Routine Microbiology and Other Reference Methods Including PCR and Sequencing Sensitivity - Pathogen Detection	91.4 Percentage Interval 91.4 to 91.4	91.4 Percentage Interval 91.4 to 91.4
Clinical Sensitivity and Specificity for Microorganism Detection as Compared to Routine Microbiology and Other Reference Methods Including PCR and Sequencing Specificity- Pathogen Detection	99.5 Percentage Interval 99.5 to 99.5	99.5 Percentage Interval 99.5 to 99.5
Clinical Sensitivity and Specificity for Microorganism Detection as Compared to Routine Microbiology and Other Reference Methods Including PCR and Sequencing Sensitivity - Restistance Marker Detection	89.9 Percentage Interval 89.9 to 89.9	89.9 Percentage Interval 89.9 to 89.9

Adverse Events

Prospective Fresh Clinical Specimens

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Retrospective Frozen Clinical Specimens

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Clinical Operations

Curetis USA, Inc.

Phone: 800-659-1221

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place