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

NCT03517007 | Completed

• 1 other identifier: Pro00092813
• Study Type: interventional
• Target: 762
• Locations: 1 country
• Sites: 10

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.

Conditions

Antibiotic Stewardship

Keywords

antibiotic de-escalation; sepsis; antimicrobial stewardship

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Distributions of DOOR

  up to 2 years

• 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

  30 days post-randomization

• 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

  30 days post-randomization

Study Arms (2)

Opt-Out Protocol

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

Provider continues routine, standard of care on the patient.

Interventions

Opt-Out Protocol OTHER

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.

Opt-Out Protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Adult patients who are located in ICU wards.

Sponsors & Collaborators

• Duke University: lead

Study Sites (10)

Piedmont Atlanta Hospital

Atlanta, Georgia, 30309, United States

Location

Piedmont Fayette Hospital

Fayetteville, Georgia, 30214, United States

Location

Piedmont Newnan Hospital

Newnan, Georgia, 30265, United States

Location

Harvard Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Southeastern Regional Medical Center

Lumberton, North Carolina, 28358, United States

Location

Iredell Health System

Statesville, North Carolina, 28677, United States

Location

Wilson Medical Center

Wilson, North Carolina, 27893, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Pennsylvania Presbyterian Hospital

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

• 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.

  PMID: 36167851 BACKGROUND

• 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.

  PMID: 36168480 BACKGROUND

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rebekah Moehring, MD, MPH

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: May 7, 2018
• Study Start: September 12, 2018
• Primary Completion: August 3, 2020
• Study Completion: August 10, 2020
• Last Updated: February 6, 2025

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)