Study to Evaluate the Effectiveness of the Initial Specimen Diversion Device When Collected Through Peripheral Intravenous Catheters

NCT ID: NCT02093494

Last Updated: 2017-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-05-31

Brief Summary

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This is a randomized, 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 PIVC's 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.

Detailed Description

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Conditions

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Septicemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Initial Specimen Diversion Device (ISDD)

The ISDD will be used to collect the blood culture.

Group Type EXPERIMENTAL

Initial Specimen Diversion Device (ISDD)

Intervention Type DEVICE

Lab standard practice (LSP)

The ISDD will not be used to collect the blood culture. Standard blood culture specimen collection kits will be utilized.

Group Type ACTIVE_COMPARATOR

Lab standard practice (LSP)

Intervention Type PROCEDURE

Peripheral Intravenous Catheters (PIVC)

Intervention Type DEVICE

Interventions

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Initial Specimen Diversion Device (ISDD)

Intervention Type DEVICE

Lab standard practice (LSP)

Intervention Type PROCEDURE

Peripheral Intravenous Catheters (PIVC)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adults \>19 years old

Exclusion Criteria

* Not a good candidates for direct-to-media (DTM) technique
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Magnolia Medical Technologies, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard Patton, M.D.

Role: STUDY_DIRECTOR

Magnolia Medical Technologies, Inc.

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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MMT1303

Identifier Type: -

Identifier Source: org_study_id

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