TerminatedNot Applicable

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

Stopped: Lack of enrollment

United States200 participantsStarted 2014-01

Plain-language summary

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.

Who can participate

Age range19 Years

SexALL

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Inclusion Criteria: * Adults \>19 years old Exclusion Criteria: * Not a good candidates for direct-to-media (DTM) technique

What they're measuring

Evaluate the rate of blood culture contamination using the Initial Specimen Diversion Device (ISDD) compared to Laboratory Standard Procedures (LSP) when collected through PIVC

Timeframe: Baseline

Trial details

NCT IDNCT02093494

SponsorMagnolia Medical Technologies, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-05

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