NCT02098226

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 27, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

February 6, 2015

Status Verified

February 1, 2015

Enrollment Period

1 year

First QC Date

March 25, 2014

Last Update Submit

February 5, 2015

Conditions

Infection

Outcome Measures

Primary Outcomes (1)

  • Substantial equivalence of MBT-CA with sequencing concerning determination of the respective bacteria and yeasts

    half a year

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with infections from certain yeasts, Gram positive or certain Gram negative bacteria (see Further Information / Target microorganisms of study)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bruker Daltonik GmbH

Bremen, City state Bremen, 28359, Germany

RECRUITING

MeSH Terms

Conditions

Infections

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2014

First Posted

March 27, 2014

Study Start

September 1, 2013

Primary Completion

September 1, 2014

Study Completion

March 1, 2015

Last Updated

February 6, 2015

Record last verified: 2015-02

Locations

DE(1)