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The DETOURS Trial: De-escalating Empiric Treatment: Opting Out of Rx for Selected Patients With Suspected Sepsis - Opt-Out Protocol Trial

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ClinicalTrials.gov Identifier: NCT03517007
Recruitment Status : Completed
First Posted : May 7, 2018
Last Update Posted : August 12, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief Summary:
The objective of this study is to implement an opt-out protocol to guide appropriate de-escalation of antibiotics in qualifying patients. The protocol, determined over the course a year with the help of a large, well-rounded expert panel, will be used by pharmacists to recommend de-escalation of antibiotics to hospital providers. Providers can then decide whether or not to follow the recommendation in determining the best treatment pathway for his or her patient.

Condition or disease Intervention/treatment Phase
Antibiotic Stewardship Other: Opt-Out Protocol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 762 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The DETOURS Trial: De-escalating Empiric Treatment: Opting Out of Rx for Selected Patients With Suspected Sepsis - Opt-Out Protocol Trial
Actual Study Start Date : September 12, 2018
Actual Primary Completion Date : August 3, 2020
Actual Study Completion Date : August 10, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Sepsis

Arm Intervention/treatment
Experimental: Opt-Out Protocol
Should an eligible patient pass the safety screen and be randomized to the intervention arm of the trial, the designated pharmacist will approach the patient's primary provider in charge of antibiotic decision-making The pharmacist will inform the provider the patient's antibiotics can be de-escalated unless the provider opts out.
Other: Opt-Out Protocol
Should an eligible patient pass the safety screen and be randomized to the intervention arm of the trial, the designated pharmacist will approach the patient's primary provider in charge of antibiotic decision-making The pharmacist will inform the provider the patient's antibiotics can be de-escalated unless the provider opts out.

No Intervention: Standard of Care
Provider continues routine, standard of care on the patient.



Primary Outcome Measures :
  1. Overall inpatient plus post-discharge antibacterial Days of Therapy (DOT) as measured by data collection [ Time Frame: 30 days post-randomization ]
    Overall inpatient plus post-discharge antibacterial Days of Therapy (DOT) as measured by data collection


Secondary Outcome Measures :
  1. Distributions of DOOR [ Time Frame: up to 2 years ]
    DOOR is defined as Desirability of Outcome Ranking, from Alive being a rank of 1 to Death being a rank of 6. DOOR will be applied to collected patient data.

  2. Negative outcomes as measured by individual clinical outcome components in the DOOR [ Time Frame: 30 days post-randomization ]
    Negative outcomes as measured by individual clinical outcome components in the DOOR

  3. Negative outcomes as measured by length of hospital stay [ Time Frame: 30 days post-randomization ]
    Negative outcomes as measured by length of hospital stay

  4. Negative outcomes as measured by re-initiation of antibiotic therapy after greater than 48 hours with no antibiotics [ Time Frame: 30 days post-randomization ]
    Negative outcomes as measured by re-initiation of antibiotic therapy after greater than 48 hours with no antibiotics

  5. Negative outcomes as measured by number of days patient has a central line [ Time Frame: 30 days post-randomization ]
    Negative outcomes as measured by number of days patient has a central line

  6. percent of eligible patients with antibiotic de-escalation [ Time Frame: 5 days from initial date of suspected sepsis ]
    percent of eligible patients with antibiotic de-escalation

  7. Number of patients in whom the safety screen was applied [ Time Frame: within 3 days (96 hours) of initial date of suspected sepsis ]
    for patients eligible for assessment of de-escalation

  8. Number of patients the safety screen excluded from the opt-out procedure [ Time Frame: within 3 days (96 hours) of initial date of suspected sepsis ]
    for patients eligible for assessment of de-escalation

  9. number of eligible patients in whom the opt-out procedure was applied [ Time Frame: within 3 days (96 hours) of initial date of suspected sepsis ]
    for patients eligible for assessment of de-escalation

  10. number of eligible patients in whom the prescriber chose to opt-out [ Time Frame: within 3 days (96 hours) of initial date of suspected sepsis ]
    for patients eligible for assessment of de-escalation

  11. prescriber type [ Time Frame: within 3 days (96 hours) of initial date of suspected sepsis ]
    for prescribers who chose to opt out

  12. prescribers' reported rationale for opting out [ Time Frame: within 3 days (96 hours) of initial date of suspected sepsis ]
    for prescribers who chose to opt out

  13. Percent of subjects who received an infectious disease consultation after implementation of the Opt-Out Protocol [ Time Frame: 30 days post-randomization ]
    Percent of subjects who received an infectious disease consultation after implementation of the Opt-Out Protocol

  14. Days of therapy for specific sub-groups of patients, including patients whose physicians elected to opt-out of the intervention [ Time Frame: 30 days post-randomization ]
    .Days of therapy for specific sub-groups of patients, including patients whose physicians elected to opt-out of the intervention



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
Criteria

Inclusion Criteria:

  • Blood culture preliminary results that indicate no growth as of 48-96 hours. (Exception: Patients with a single positive blood culture for coagulase negative Staphylococcus and no central line in place will also be included).
  • Still on broad spectrum antibiotic therapy after 48-96 hours.

Exclusion Criteria:

  • Adult patients who are located in ICU wards.

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): NCT03517007


Locations
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United States, Georgia
Piedmont Atlanta Hospital
Atlanta, Georgia, United States, 30309
Piedmont Fayette Hospital
Fayetteville, Georgia, United States, 30214
Piedmont Newnan Hospital
Newnan, Georgia, United States, 30265
United States, Massachusetts
Harvard Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
Southeastern Regional Medical Center
Lumberton, North Carolina, United States, 28358
Iredell Health System
Statesville, North Carolina, United States, 28677
Wilson Medical Center
Wilson, North Carolina, United States, 27893
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Pennsylvania Presbyterian Hospital
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Rebekah Moehring, MD, MPH Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03517007    
Other Study ID Numbers: Pro00092813
First Posted: May 7, 2018    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
antibiotic de-escalation
sepsis
antimicrobial stewardship
Additional relevant MeSH terms:
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Sepsis
Infections
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes