Study Stopped
Lack of enrollment
Study to Evaluate the Effectiveness of the Initial Specimen Diversion Device When Collected Through Peripheral Intravenous Catheters
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)
1 other identifier
interventional
200
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 17, 2014
CompletedFirst Posted
Study publicly available on registry
March 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedAugust 11, 2017
August 1, 2017
1.3 years
March 17, 2014
August 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Evaluate the occurrence of any adverse device effects
Baseline
Other Outcomes (1)
Evaluate the contamination rates, taking into account the confounding effects of blood draw setting and departure from direct-to-media (DTM) technique
Baseline
Study Arms (2)
Initial Specimen Diversion Device (ISDD)
EXPERIMENTALThe ISDD will be used to collect the blood culture.
Lab standard practice (LSP)
ACTIVE COMPARATORThe ISDD will not be used to collect the blood culture. Standard blood culture specimen collection kits will be utilized.
Interventions
Eligibility Criteria
You may qualify if:
- Adults \>19 years old
You may not qualify if:
- Not a good candidates for direct-to-media (DTM) technique
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Richard Patton, M.D.
Magnolia Medical Technologies, Inc.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2014
First Posted
March 21, 2014
Study Start
January 1, 2014
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
August 11, 2017
Record last verified: 2017-08