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NCT Number: NCT02102087

Study to Evaluate the Effectiveness of the Initial Specimen Diversion Device

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.

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Key information

Conditions

Septicemia Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults >19 years old

Exclusion criteria

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

Treatment and study plan

Initial Specimen Diversion Device (ISDD)

Device

Lab standard practice (LSP)

Device

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Magnolia Medical Technologies, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 2, 2014
Registry last updated
Aug 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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