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OR PathTrac (Tracking Intra-operative Bacterial Transmission)

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ClinicalTrials.gov Identifier: NCT03605498
Recruitment Status : Completed
First Posted : July 30, 2018
Last Update Posted : March 1, 2019
Sponsor:
Collaborators:
B. Braun Medical Inc.
RDB Bioinformatics, LLC
Information provided by (Responsible Party):
Sundara Reddy, University of Iowa

Brief Summary:
Healthcare-associated infections occur frequently and are associated with patient harm. These infections are becoming more difficult to treat due to antibiotic resistance. It is important that healthcare facilities take the steps necessary to prevent the spread of resistant bacteria between patients.

Condition or disease
Bacterial Infections

Detailed Description:
Two patients undergoing sedation in a randomly selected operating room will be evaluated in a serial manner in order to detect transmission of pathogenic bacteria. Patient care will not change due to their participation in this study; the patients will undergo sedation and surgery according to usual practice. This study involves taking microbiology cultures from various places in the operating room before and after each procedure. Cultures will also be taken from the two patients after they are asleep and from their intravenous tubing. From both patients anesthesiologist, surgeon and their surgical team, cRNA, and nursing staff will also have cultures obtained. Each cultures will be de-identified and given a study ID number before transport to the research laboratory for microbiological assay. The patient's medical record will be reviewed for 30 days after surgery to surveil for documentation of a potential hospital acquired infection.

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Study Type : Observational
Actual Enrollment : 83 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Investigation of Novel Technology to Bring Genomic Analysis to the Patient Bedside to Systematically Track and Report on ESKAPE Bacterial Transmission in Today's Operating Room Environments
Actual Study Start Date : September 5, 2017
Actual Primary Completion Date : February 12, 2018
Actual Study Completion Date : February 12, 2018



Primary Outcome Measures :
  1. Identify transmission dynamics of pathogenic bacteria (i.e. Staph aureus). [ Time Frame: Intraoperative period ]
    Focus on how Staph aureus is transmitted in the operating room by identifying key areas of origin.

  2. Intraoperative clonal transmission of Staph aureus. [ Time Frame: Intraoperative period ]
    Monitor locations throughout the operating room to document clonal transmission from the area of origin.

  3. Identify the modes of transmission of pathogenic bacteria ((i.e. Staph aureus). [ Time Frame: Intraoperative period ]
    If transmission of Staph aureus from the site of origin to another site in the operating room arena is documented, identify the modes of transmission.


Secondary Outcome Measures :
  1. Monitor for post operative healthcare associated infections. [ Time Frame: Up to 30 days following surgery ]
    Monitor for the presence or absence of healthcare associated infection after undergoing an operative procedure.

  2. Surveil for molecular links between pathogenic organisms. [ Time Frame: Up to 30 days following surgery ]
    Seek to identify molecular links between causative organisms of infection and bacteria found in the operating room at the time of surgery.


Biospecimen Retention:   Samples With DNA
The bacterial cultures can be kept and analyzed at a later date to determine how they have transformed into antibiotic resistant organisms.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 105 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study population will be surgical patients requiring peripheral intravenous and/or central venous catheter access and undergoing gynecology/oncology, colorectal, open vascular, total joint or cardiovascular procedures.
Criteria

Inclusion Criteria:

  • At least 18 years of age
  • Require peripheral intravenous and/or central venous catheter placement
  • Undergoing gynecology/oncology, colorectal, open vascular, total joint or cardiovascular procedures.

Exclusion Criteria:

  • Less than 18 years of age
  • Does not require peripheral intravenous and/or central venous catheter placement
  • Patient refusal to participate
  • Incarceration

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03605498


Locations
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United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Sundara Reddy
B. Braun Medical Inc.
RDB Bioinformatics, LLC
Investigators
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Principal Investigator: Sundara Reddy, MBBS, FRCA University of Iowa

Additional Information:
Publications:
World Health Organization. Antimicrobial Resistance. Global Report on Surveillance, WHO. 2014
Raudenbush SW. Hierarchical Linear Models: Applications and Data Analysis Methods. Newbury Park, CA: Sage; 2002.
Wikler M, Cockerill F, Craig W, Dudley M, Eliopoulos G, Hecht P, Hindler J, Low D, Sheehan D, Tenover F, Turnidge J, Weinstein M, Zimmer B. Clinical and Laboratory Standards Institute: Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard-9th 10th edition. 2009, Wayne, PA, Clinical and Laboratory Standards Institute, 2006, pp M2 M02-A9A10

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Responsible Party: Sundara Reddy, Clinical Associate Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT03605498     History of Changes
Other Study ID Numbers: 201705826
First Posted: July 30, 2018    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All of the individual participant data collected during the trial, after deidentification will be shared with researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal. IPD will be available for sharing immediately after publication and ending 5 years following article publication.
Supporting Materials: Study Protocol
Time Frame: IPD will be available for sharing immediately after publication and ending 5 years following article publication.
Access Criteria: IPD will be accessible to researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bacterial Infections