Study to Evaluate the Effectiveness of the Initial Specimen Diversion Device

August 9, 2017 updated by: Magnolia Medical Technologies, Inc.

A Matched, Open Label Study to Evaluate the Effectiveness of the MMT Initial Specimen Diversion Device in Reducing Blood Culture Contamination When Compared to Laboratory Standard Procedures

This is a matched, open label study to evaluate the Initial Specimen Diversion Device (ISDD) in reducing the contamination rate in blood culture analysis. Blood culture data will be derived from inpatient and/or outpatient settings in a variety of hospital departments (e.g. ER, surgical, medical, etc.). Only samples that are collected via peripheral venipuncture may be included in this study. The ISDD will be compared to current laboratory practices for the collection of blood for culture purposes. Laboratory Standard Procedures (LSP) is defined as collection of venipuncture blood for culture without an initial diversion method to divert and sequester potential blood contaminants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

971

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults >19 years old

Exclusion Criteria:

  • Not a good candidate for direct-to-media (DTM) technique

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Initial Specimen Diversion Device (ISDD)
The ISDD will be used in conjunction with standard blood culture bottles.
Device: Initial Specimen Diversion Device (ISDD)
Active Comparator: Lab standard practice (LSP)
A standard blood culture kit will be used.
Device: Lab standard practice (LSP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of blood culture contamination when using the Initial Specimen Diversion Device (ISDD) compared to Laboratory Standard Procedures (LSP)
Time Frame: Baseline
Comparison of contamination for each clinical episode. The proportions of discordant contamination episodes will be compared between the Initial Specimen Diversion Device and Lab Standard Practice using McNemar's test.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence rate of adverse device effects
Time Frame: Baseline
As the device under study enhances the blood diversion procedure during blood culture collection, and is part of standard blood collection standards, adverse device effects are not expected as a result of use of this device, but shall be recorded consistent with the adverse event definitions found in 21 CFR 812. As this is a commercially available device, medical device reporting shall be performed in accordance with 21 CFR 803, as applicable.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Magnolia Medical Technologies, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

March 21, 2014

First Submitted That Met QC Criteria

March 30, 2014

First Posted (Estimate)

April 2, 2014

Study Record Updates

Last Update Posted (Actual)

August 11, 2017

Last Update Submitted That Met QC Criteria

August 9, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMT1302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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