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

Septicemia Clinical Trial

Official title:

A Randomized, Open Label Study to Evaluate the Effectiveness of the MMT Initial Specimen Diversion Device in Reducing Blood Culture Contamination Compared to Laboratory Standard Procedures When Collected Through Peripheral Intravenous Catheters (PIVC)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02093494
• Other study ID #: MMT1303
• Status: Terminated
• Phase: N/A
• First received: March 17, 2014
• Last updated: August 9, 2017
• Start date: January 2014
• Est. completion date: May 2015

Study information

• Verified date: August 2017
• Source: Magnolia Medical Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Adults >19 years old

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Sepsis
• Septicemia
• Toxemia

Intervention

Device:
• Initial Specimen Diversion Device (ISDD)

Procedure:
• Lab standard practice (LSP)

Device:
• Peripheral Intravenous Catheters (PIVC)

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Magnolia Medical Technologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluate the contamination rates, taking into account the confounding effects of blood draw setting and departure from direct-to-media (DTM) technique		Baseline
Primary	Evaluate the rate of blood culture contamination using the Initial Specimen Diversion Device (ISDD) compared to Laboratory Standard Procedures (LSP) when collected through PIVC		Baseline
Secondary	Evaluate the occurrence of any adverse device effects	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. Any issues with the function of the device will be reported by the phlebotomist on a device incident form. The sponsor will maintain these reports in a database. As this is a commercially available device, medical device reporting shall be performed in accordance with 21 CFR 803, as applicable.	Baseline