Study to Evaluate the Effectiveness of the Initial Specimen Diversion Device

NCT02102087 — Not applicable, Completed, 971 participants, Magnolia Medical Technologies, Inc.

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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

Registry	NCT02102087
Status	Completed
Phase	Not applicable
Study type	Interventional; non randomized, parallel, masking: none, diagnostic
Enrollment	971 (Actual)
Sponsor	Magnolia Medical Technologies, Inc. (Industry)
Conditions	Septicemia
Interventions	Initial Specimen Diversion Device (ISDD), Lab standard practice (LSP) (Device)
Dates	start 2014-07-01, primary completion 2015-10-01, completion 2015-10-01, first posted 2014-04-02, last updated 2017-08-11
Locations	1 site in United States

-Summary

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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+Arms and interventions

Arm	Type	Interventions	Description
Initial Specimen Diversion Device (ISDD)	Experimental	Device: Initial Specimen Diversion Device (ISDD)	The ISDD will be used in conjunction with standard blood culture bottles.
Lab standard practice (LSP)	Active comparator	Device: Lab standard practice (LSP)	A standard blood culture kit will be used.

Initial Specimen Diversion Device (ISDD) (Device)
Lab standard practice (LSP) (Device)

+Outcome measures

Primary outcomes

Rate of blood culture contamination when using the Initial Specimen Diversion Device (ISDD) compared to Laboratory Standard Procedures (LSP) [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

Occurrence rate of adverse device effects [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.

+Eligibility

Sex: All, ages: 19 Years to any

Inclusion Criteria:

* Adults >19 years old

Exclusion Criteria:

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

+Locations (1)

Facility	City	Country	Status
University of Nebraska Medical Center	Omaha, Nebraska	United States

+Publications

Results publication: 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. PMID 28379370