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

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.

Study Overview

• Status: Completed
• Conditions: Antibiotic Stewardship
• Intervention / Treatment: Other: Opt-Out Protocol

• Study Type: Interventional
• Enrollment (Actual): 762
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Piedmont Atlanta Hospital
    • Fayetteville, Georgia, United States, 30214
      • Piedmont Fayette Hospital
    • Newnan, Georgia, United States, 30265
      • Piedmont Newnan Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Harvard Brigham and Women's Hospital
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University
    • Lumberton, North Carolina, United States, 28358
      • Southeastern Regional Medical Center
    • Statesville, North Carolina, United States, 28677
      • Iredell Health System
    • Wilson, North Carolina, United States, 27893
      • Wilson Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of The University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Pennsylvania Presbyterian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall inpatient plus post-discharge antibacterial Days of Therapy (DOT) as measured by data collection	Overall inpatient plus post-discharge antibacterial Days of Therapy (DOT) as measured by data collection	30 days post-randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distributions of DOOR	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.	up to 2 years
Negative outcomes as measured by individual clinical outcome components in the DOOR	Negative outcomes as measured by individual clinical outcome components in the DOOR	30 days post-randomization
Negative outcomes as measured by length of hospital stay	Negative outcomes as measured by length of hospital stay	30 days post-randomization
Negative outcomes as measured by re-initiation of antibiotic therapy after greater than 48 hours with no antibiotics	Negative outcomes as measured by re-initiation of antibiotic therapy after greater than 48 hours with no antibiotics	30 days post-randomization
Negative outcomes as measured by number of days patient has a central line	Negative outcomes as measured by number of days patient has a central line	30 days post-randomization
percent of eligible patients with antibiotic de-escalation	percent of eligible patients with antibiotic de-escalation	5 days from initial date of suspected sepsis
Number of patients in whom the safety screen was applied	for patients eligible for assessment of de-escalation	within 3 days (96 hours) of initial date of suspected sepsis
Number of patients the safety screen excluded from the opt-out procedure	for patients eligible for assessment of de-escalation	within 3 days (96 hours) of initial date of suspected sepsis
number of eligible patients in whom the opt-out procedure was applied	for patients eligible for assessment of de-escalation	within 3 days (96 hours) of initial date of suspected sepsis
number of eligible patients in whom the prescriber chose to opt-out	for patients eligible for assessment of de-escalation	within 3 days (96 hours) of initial date of suspected sepsis
prescriber type	for prescribers who chose to opt out	within 3 days (96 hours) of initial date of suspected sepsis
prescribers' reported rationale for opting out	for prescribers who chose to opt out	within 3 days (96 hours) of initial date of suspected sepsis
Percent of subjects who received an infectious disease consultation after implementation of the Opt-Out Protocol	Percent of subjects who received an infectious disease consultation after implementation of the Opt-Out Protocol	30 days post-randomization
Days of therapy for specific sub-groups of patients, including patients whose physicians elected to opt-out of the intervention	.Days of therapy for specific sub-groups of patients, including patients whose physicians elected to opt-out of the intervention	30 days post-randomization

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Rebekah Moehring, MD, MPH, Duke University

Publications and helpful links

General Publications

• Moehring RW, Yarrington ME, Warren BG, Lokhnygina Y, Atkinson E, Bankston A, Collucio J, David MZ, Davis AE, Davis J, Dionne B, Dyer AP, Jones TM, Klompas M, Kubiak DW, Marsalis J, Omorogbe J, Orajaka P, Parish A, Parker T, Pearson JC, Pearson T, Sarubbi C, Shaw C, Spivey J, Wolf R, Wrenn RH, Dodds Ashley ES, Anderson DJ; Centers for Disease Control and Prevention's Prevention Epicenters Program. Evaluation of an Opt-Out Protocol for Antibiotic De-Escalation in Patients With Suspected Sepsis: A Multicenter, Randomized, Controlled Trial. Clin Infect Dis. 2023 Feb 8;76(3):433-442. doi: 10.1093/cid/ciac787.
• Yarrington ME, Moehring RW, David MZ, Hamilton KW, Klompas M, Rhee C, Hsueh K, Ashley ED, Sinkowitz-Cochran RL, Ryan M, Anderson DJ; DETOURS Expert Panel of the CDC Prevention Epicenters Program. A modified Delphi approach to develop a trial protocol for antibiotic de-escalation in patients with suspected sepsis. Antimicrob Steward Healthc Epidemiol. 2021 Nov 8;1(1):e44. doi: 10.1017/ash.2021.205. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2018
• Primary Completion (Actual): August 3, 2020
• Study Completion (Actual): August 10, 2020

Study Registration Dates

• First Submitted: May 3, 2018
• First Submitted That Met QC Criteria: May 3, 2018
• First Posted (Actual): May 7, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: sepsis; antimicrobial stewardship; antibiotic de-escalation
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis
• Other Study ID Numbers: Pro00092813

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No