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Trial record 74 of 228 for:    yeast

Evaluation of MALDI Biotyper CA System for Detection of Gram- and Gram+ Bacteria and Yeasts

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ClinicalTrials.gov Identifier: NCT02098226
Recruitment Status : Unknown
Verified February 2015 by Bruker Daltonics.
Recruitment status was:  Recruiting
First Posted : March 27, 2014
Last Update Posted : February 6, 2015
Sponsor:
Information provided by (Responsible Party):
Bruker Daltonics

Brief Summary:
The study objective is to confirm that the MBT-CA System identifies medically significant bacteria and yeasts from an isolated colony from any sample type processed by the clinical laboratory. For this purpose MBT-CA test results will be compared to bi-directional sequencing results.

Condition or disease
Infection

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 3000 participants
Time Perspective: Prospective
Official Title: Method Comparison Protocol: MALDI Biotyper-Clinical Applications (MBT-CA) Phase 2
Study Start Date : September 2013
Actual Primary Completion Date : September 2014
Estimated Study Completion Date : March 2015



Primary Outcome Measures :
  1. Substantial equivalence of MBT-CA with sequencing concerning determination of the respective bacteria and yeasts [ Time Frame: half a year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with infections from certain yeasts, Gram positive or certain Gram negative bacteria (see Further Information / Target microorganisms of study)
Criteria

Inclusion Criteria:

-Patients with infections from certain yeasts, Gram positive or Gram negative bacteria (see Detailed Description)

Exclusion Criteria:

-Patients without infections from the quoted microorganisms (see Detailed Description)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02098226


Locations
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Germany
Bruker Daltonik GmbH Recruiting
Bremen, Germany, 28359
Contact: Markus Kostrzewa, Ph:D.       markus.kostrzewa@bruker.com   
Contact: Jens Pfannkuche, Ph.D.       jens.pfannkuche@bruker.com   
Sponsors and Collaborators
Bruker Daltonics

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Responsible Party: Bruker Daltonics
ClinicalTrials.gov Identifier: NCT02098226     History of Changes
Other Study ID Numbers: BDAL-2013-001
First Posted: March 27, 2014    Key Record Dates
Last Update Posted: February 6, 2015
Last Verified: February 2015