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Trial record 65 of 159 for:    Urinary Tract Infections | Recruiting, Not yet recruiting, Available Studies | "Communicable Diseases"

Prevalence of Antimicrobial-resistant Pathogens in Patients Admitted for UTIs

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ClinicalTrials.gov Identifier: NCT03346603
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : April 10, 2018
Sponsor:
Collaborators:
Centers for Disease Control and Prevention
IHMA laboratories
Information provided by (Responsible Party):
David A. Talan, Olive View-UCLA Education & Research Institute

Brief Summary:
Between 2013-2014, our study network of U.S. emergency departments, EMERGEncy ID NET, found that the rate of fluoroquinolone-resistant E. coli was 11.7% among all patients, 6.3% in uncomplicated and 19.9% in complicated. ESBL-producing Enterobacteriaceae were found in 7.7% of all cases, 2.6% in uncomplicated and 12.2% in complicated. More recently, Enterobactericeae and gram-negative non fermenting bacteria have started to show resistance to carbapenems (CREs and CR-NF). Patients hospitalized with UTI and urosepsis represent a higher risk population for infections due to multi-drug resistant bacteria and experience serious adverse outcomes, including death. EMERGEncy ID NET will conduct a study to determine the prevalence of ESBL-producing, CREs and CR-NFs among this high risk population of patients admitted for UTI from U.S. emergency departments.

Condition or disease Intervention/treatment
Urinary Tract Infections Urosepsis Other: urine culture and susceptibility testing

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Study Type : Observational
Estimated Enrollment : 650 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prevalence of Extended Spectrum β-lactamase and Carbapenem-Resistant Gram-Negative Bacteria in Patients With Urinary Tract Infection and Urosepsis Admitted Through Emergency Departments in the United States
Actual Study Start Date : February 8, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: urine culture and susceptibility testing
    All patients will have a urine culture and susceptibility test ordered per standard care. Results of tests will identify which patients have antimicrobial-resistant organisms.


Primary Outcome Measures :
  1. Prevalence of ESBL-producing Enterobacteriaceae [ Time Frame: 2 years ]
  2. Prevalence of carbapenem-resistant Enterobacteriaceae (CRE) [ Time Frame: 2 years ]
  3. Prevalence of carbapenem-resistant non fermenting gram negative bacteria [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients presenting to the 11 U.S. emergency departments involved in the EMERGEncy ID NET study with a urinary tract infection requiring hospital admission.

The sites are:

Bellevue Hospital Center, New York; Brigham and Women's Hospital, Boston, MA; Hennepin County Medical Center, Minneapolis; Johns Hopkins Medical Center, Baltimore; Lewis Katz School of Medicine at Temple University, Philadelphia; Maricopa Medical Center, Phoenix; Oregon Health Sciences University, Portland; Olive View-University of California at Los Angeles Medical Center, Los Angeles; University of New Mexico Health Sciences Center, Albuquerque; University of Mississippi Medical Center, Jackson; University of Missouri-Kansas City, Kansas City.

Criteria

Inclusion Criteria:

  1. Age greater than or equal to 18 years;
  2. Admitted to the hospital through the ED;
  3. Primary reason for admission is treatment of UTI with or without sepsis (i.e., ED diagnosis of UTI and/or sepsis); and
  4. Provide verbal or written consent to participate in the study or if patient is unable to provide consent (e.g., altered mental status), consent obtained from a legal authorized representative.

Exclusion Criteria:

  • patients will be later excluded if :

    1. they are unable to provide a urine specimen for culture; or
    2. their urine culture yields no growth or is contaminated (see definition of positive urine culture below). Note: If participant's urine culture is contaminated but their blood culture is positive for a uropathogen, they will not be excluded.

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): NCT03346603


Contacts
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Contact: David Talan, MD 747-210-3107 dtalan@ucla.edu
Contact: Anusha Krishnadasan, PhD 747-210-3111 idnet@ucla.edu

Locations
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United States, California
Olive View-UCLA Medical Center Recruiting
Sylmar, California, United States, 93311
Contact: Anusha Krishnadasan, PhD       idnet@ucla.edu   
Sponsors and Collaborators
Olive View-UCLA Education & Research Institute
Centers for Disease Control and Prevention
IHMA laboratories

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Responsible Party: David A. Talan, Professor of Medicine in Residence, Olive View-UCLA Education & Research Institute
ClinicalTrials.gov Identifier: NCT03346603     History of Changes
Other Study ID Numbers: 1057381
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Final research data will be shared with interested parties affiliated with research organizations, local and U.S. state health departments, and universities, who are interested in using the data for research purposes. Interested parties must submit a short description of how they plan to use the data to the Principal Investigator for approval. A data-sharing agreement will be required containing conditions for data use, including (1): a commitment to using the data only for research purposes; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroy or return the data after analyses are completed. Upon approval, the database will be shared with the requestor. All shared final research databases will not contain direct or indirect personal identifiers, and subjects will only be discernible by unique study identification numbers. A file containing a data dictionary with descriptions of all database fields will be included.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: Approximately one year after main manuscript publication. Data will be available for 15 years.
Access Criteria: Data sharing agreement

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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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Infection
Urinary Tract Infections
Urologic Diseases