Study to Evaluate the Effectiveness of the Initial Specimen Diversion Device

NCT ID: NCT02102087

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

COMPLETED

Clinical Phase

NA

Total Enrollment

971 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Septicemia

Study Design

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Allocation Method

NON_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 in conjunction with standard blood culture bottles.

Group Type EXPERIMENTAL

Initial Specimen Diversion Device (ISDD)

Intervention Type DEVICE

Lab standard practice (LSP)

A standard blood culture kit will be used.

Group Type ACTIVE_COMPARATOR

Lab standard practice (LSP)

Intervention Type DEVICE

Interventions

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Initial Specimen Diversion Device (ISDD)

Intervention Type DEVICE

Lab standard practice (LSP)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adults \>19 years old

Exclusion Criteria

* Not a good candidate 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

Locations

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University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

Countries

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United States

References

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Rupp ME, Cavalieri RJ, Marolf C, Lyden E. Reduction in Blood Culture Contamination Through Use of Initial Specimen Diversion Device. Clin Infect Dis. 2017 Jul 15;65(2):201-205. doi: 10.1093/cid/cix304.

Reference Type RESULT
PMID: 28379370 (View on PubMed)

Other Identifiers

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MMT1302

Identifier Type: -

Identifier Source: org_study_id

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