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AzTrials

Bacterial InfectionsNCT03605498

OR PathTrac (Tracking Intra-operative Bacterial Transmission)

An observational study of Bacterial Infections, run by Sundara Reddy at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 105 yearsHealthy volunteers can take part
Conditions the study is for
Bacterial Infections
How many people
83 participants
Where
1 siteUnited States
Study dates
5 Sep 2017to 12 Feb 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 105 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

Other trials in United States

About this study

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

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.

Read the 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.

Medical subject headings
Bacterial Infections

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Identify transmission dynamics of pathogenic bacteria (i.e. Staph aureus).

    Focus on how Staph aureus is transmitted in the operating room by identifying key areas of origin.

    Measured: Intraoperative period

  2. Intraoperative clonal transmission of Staph aureus.

    Monitor locations throughout the operating room to document clonal transmission from the area of origin.

    Measured: Intraoperative period

  3. Identify the modes of transmission of pathogenic bacteria ((i.e. Staph aureus).

    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.

    Measured: Intraoperative period

Secondary outcomes (2)

  1. Monitor for post operative healthcare associated infections.

    Monitor for the presence or absence of healthcare associated infection after undergoing an operative procedure.

    Measured: Up to 30 days following surgery

  2. Surveil for molecular links between pathogenic organisms.

    Seek to identify molecular links between causative organisms of infection and bacteria found in the operating room at the time of surgery.

    Measured: Up to 30 days following surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2018
  2. Study start5 Sep 2017
  3. Primary completion12 Feb 2018
  4. Study completion12 Feb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03605498
Sponsor's protocol ID
201705826
Status last verified
Feb 2019
First submitted
8 Jun 2018
Last updated
1 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Vogel TR, Dombrovskiy VY, Lowry SF. Impact of infectious complications after elective surgery on hospital readmission and late deaths in the U.S. Medicare population. Surg Infect (Larchmt). 2012 Oct;13(5):307-11. doi: 10.1089/sur.2012.116. Epub 2012 Oct 19.

    PubMed 23082877

  • Koff MD, Brown JR, Marshall EJ, O'Malley AJ, Jensen JT, Heard SO, Longtine K, O'Neill M, Longtine J, Houston D, Robison C, Moulton E, Patel HM, Loftus RW. Frequency of Hand Decontamination of Intraoperative Providers and Reduction of Postoperative Healthcare-Associated Infections: A Randomized Clinical Trial of a Novel Hand Hygiene System. Infect Control Hosp Epidemiol. 2016 Aug;37(8):888-895. doi: 10.1017/ice.2016.106. Epub 2016 Jun 7.

    PubMed 27267310

  • Kirkland KB, Briggs JP, Trivette SL, Wilkinson WE, Sexton DJ. The impact of surgical-site infections in the 1990s: attributable mortality, excess length of hospitalization, and extra costs. Infect Control Hosp Epidemiol. 1999 Nov;20(11):725-30. doi: 10.1086/501572.

    PubMed 10580621

  • World Health Organization. Antimicrobial Resistance. Global Report on Surveillance, WHO. 2014

  • German RR, Lee LM, Horan JM, Milstein RL, Pertowski CA, Waller MN; Guidelines Working Group Centers for Disease Control and Prevention (CDC). Updated guidelines for evaluating public health surveillance systems: recommendations from the Guidelines Working Group. MMWR Recomm Rep. 2001 Jul 27;50(RR-13):1-35; quiz CE1-7.

    PubMed 18634202

  • Boucher HW, Talbot GH, Bradley JS, Edwards JE, Gilbert D, Rice LB, Scheld M, Spellberg B, Bartlett J. Bad bugs, no drugs: no ESKAPE! An update from the Infectious Diseases Society of America. Clin Infect Dis. 2009 Jan 1;48(1):1-12. doi: 10.1086/595011.

    PubMed 19035777

  • Loftus RW, Koff MD, Burchman CC, Schwartzman JD, Thorum V, Read ME, Wood TA, Beach ML. Transmission of pathogenic bacterial organisms in the anesthesia work area. Anesthesiology. 2008 Sep;109(3):399-407. doi: 10.1097/ALN.0b013e318182c855.

    PubMed 18719437

  • Loftus RW, Brown JR, Koff MD, Reddy S, Heard SO, Patel HM, Fernandez PG, Beach ML, Corwin HL, Jensen JT, Kispert D, Huysman B, Dodds TM, Ruoff KL, Yeager MP. Multiple reservoirs contribute to intraoperative bacterial transmission. Anesth Analg. 2012 Jun;114(6):1236-48. doi: 10.1213/ANE.0b013e31824970a2. Epub 2012 Mar 30.

    PubMed 22467892

  • Loftus RW, Koff MD, Brown JR, Patel HM, Jensen JT, Reddy S, Ruoff KL, Heard SO, Yeager MP, Dodds TM. The epidemiology of Staphylococcus aureus transmission in the anesthesia work area. Anesth Analg. 2015 Apr;120(4):807-18. doi: 10.1213/ANE.0b013e3182a8c16a.

    PubMed 24937345

  • Loftus RW, Koff MD, Brown JR, Patel HM, Jensen JT, Reddy S, Ruoff KL, Heard SO, Yeager MP, Dodds TM. The dynamics of Enterococcus transmission from bacterial reservoirs commonly encountered by anesthesia providers. Anesth Analg. 2015 Apr;120(4):827-36. doi: 10.1213/ANE.0000000000000123.

    PubMed 24937346

  • Loftus RW, Brown JR, Patel HM, Koff MD, Jensen JT, Reddy S, Ruoff KL, Heard SO, Dodds TM, Beach ML, Yeager MP. Transmission dynamics of gram-negative bacterial pathogens in the anesthesia work area. Anesth Analg. 2015 Apr;120(4):819-26. doi: 10.1213/ANE.0000000000000626.

    PubMed 25790209

  • Mabit C, Marcheix PS, Mounier M, Dijoux P, Pestourie N, Bonnevialle P, Bonnomet F; French Society of Orthopaedic Surgery, Traumatology (SOFCOT). Impact of a surgical site infection (SSI) surveillance program in orthopedics and traumatology. Orthop Traumatol Surg Res. 2012 Oct;98(6):690-5. doi: 10.1016/j.otsr.2012.08.001. Epub 2012 Sep 15.

    PubMed 22986014

  • Loftus RW, Muffly MK, Brown JR, Beach ML, Koff MD, Corwin HL, Surgenor SD, Kirkland KB, Yeager MP. Hand contamination of anesthesia providers is an important risk factor for intraoperative bacterial transmission. Anesth Analg. 2011 Jan;112(1):98-105. doi: 10.1213/ANE.0b013e3181e7ce18. Epub 2010 Aug 4.

    PubMed 20686007

  • Loftus RW, Patel HM, Huysman BC, Kispert DP, Koff MD, Gallagher JD, Jensen JT, Rowlands J, Reddy S, Dodds TM, Yeager MP, Ruoff KL, Surgenor SD, Brown JR. Prevention of intravenous bacterial injection from health care provider hands: the importance of catheter design and handling. Anesth Analg. 2012 Nov;115(5):1109-19. doi: 10.1213/ANE.0b013e31826a1016. Epub 2012 Oct 9.

    PubMed 23051883

  • Loftus RW, Brindeiro BS, Kispert DP, Patel HM, Koff MD, Jensen JT, Dodds TM, Yeager MP, Ruoff KL, Gallagher JD, Beach ML, Brown JR. Reduction in intraoperative bacterial contamination of peripheral intravenous tubing through the use of a passive catheter care system. Anesth Analg. 2012 Dec;115(6):1315-23. doi: 10.1213/ANE.0b013e31826d2aa4. Epub 2012 Nov 9.

    PubMed 23144441

Questions about this trial

What is this clinical trial studying?

An observational study of Bacterial Infections, run by Sundara Reddy at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Identify transmission dynamics of pathogenic bacteria (i.e. Staph aureus). (time frame: Intraoperative period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03605498, which also lists 37 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2019.

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