Study to Evaluate the Effectiveness of the Initial Specimen Diversion Device

Magnolia Medical Technologies

Status: Completed

Conditions: Septicemia

Treatments: Device: Initial Specimen Diversion Device (ISDD); Device: Lab standard practice (LSP)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02102087

MMT1302

Details and patient eligibility

About

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.

Enrollment: 971 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults >19 years old

Exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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971 participants in 2 patient groups

Initial Specimen Diversion Device (ISDD)

Experimental group

Description:

The ISDD will be used in conjunction with standard blood culture bottles.

Treatment:

Device: Initial Specimen Diversion Device (ISDD)

Lab standard practice (LSP)

Active Comparator group

Description:

A standard blood culture kit will be used.

Treatment:

Device: Lab standard practice (LSP)