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)
Verified date | August 2017 |
Source | Magnolia Medical Technologies, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Magnolia Medical Technologies, Inc. |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT04764058 -
Efficacy and Safety of Colistin Based Antibiotic Therapy
|
Phase 1/Phase 2 | |
Completed |
NCT03088865 -
Evaluation of an Internal Hospital Practice: The Effect of Altered Test Tubes Sampling Order on Blood Culture Contamination Rates
|
N/A | |
Completed |
NCT00046072 -
A Safety and Efficacy Study of Intravenous E5564 in Patients With Severe Sepsis
|
Phase 2 | |
Completed |
NCT01520597 -
National Study on Listeriosis and Listeria
|
||
Recruiting |
NCT03929159 -
Correlating MicroRNA Changes With Sepsis Outcomes
|
||
Completed |
NCT03943719 -
Clinical Impact of the FilmArray Blood Culture Identification Panel Performed on Positive Blood Cultures From Intensive Care Patients With Septicemia
|
||
Completed |
NCT00901940 -
Understanding the Immune Response to Meningitis Vaccines
|
Phase 3 | |
Not yet recruiting |
NCT03583762 -
Time to Appropriate Antibiotic Between Using Microarray Assay and Mass Spectrometry Technique
|
N/A | |
Completed |
NCT02988414 -
Diagnosis of Bacteremia/Septicemia and Culture Negative Endocarditis by the Karius Sequencing-Based Infectious Disease Diagnostic Assay
|
||
Completed |
NCT02102087 -
Study to Evaluate the Effectiveness of the Initial Specimen Diversion Device
|
N/A | |
Recruiting |
NCT05045963 -
Impact of Aminoglycosides in Hypotensive Septic Oncology Patients
|
||
Active, not recruiting |
NCT02069028 -
Effectiveness of Different Interventions for Implementing Surviving Sepsis Campaign (SSC) Guidelines on Compliance and Mortality: Systematic Review and Meta-analysis
|
N/A | |
Recruiting |
NCT00258869 -
Observational Study of Sepsis and Pneumonia to Develop Diagnostic Tests
|
N/A | |
Completed |
NCT05358912 -
Efficacy of Targeted Abdominal Perfusion Pressure in Septic Shock
|
Phase 4 | |
Recruiting |
NCT05893420 -
A Rapid Diagnostic of Risk in Hospitalized Patients Using Machine Learning
|
N/A | |
Recruiting |
NCT05040503 -
Monitoring Mitophagy In Myeloid Cells Upon Intensive Care
|
N/A | |
Completed |
NCT00146432 -
Immunoadsorption of LPS, C5a and IL-6 in Severe Sepsis and Septic Shock (ISASS-1)
|
Phase 2/Phase 3 | |
No longer available |
NCT04636554 -
Personalized Phage Treatment in Covid-19 Patients With Bacterial Co-Infections Microbials for Pneumonia or Bacteremia/Septicemia
|