Clinical trial NCT03517007: The DETOURS Trial: De-escalating Empiric Treatment: Opting Out of Rx for Selected Patients With Suspected Sepsis - Opt-Out Protocol Trial
Official title: The DETOURS Trial: De-escalating Empiric Treatment: Opting Out of Rx for Selected Patients With Suspected Sepsis - Opt-Out Protocol Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Antibiotic Stewardship
Keywords: antibiotic de-escalation
sepsis
antimicrobial stewardship
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2018-05-07
Enrollment: 762
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Overall inpatient plus post-discharge antibacterial Days of Therapy (DOT) as measured by data collection
timeFrame: 30 days post-randomization
Secondary outcomes:
measure: Distributions of DOOR
timeFrame: up to 2 years
measure: Negative outcomes as measured by individual clinical outcome components in the DOOR
timeFrame: 30 days post-randomization
measure: Negative outcomes as measured by length of hospital stay
timeFrame: 30 days post-randomization
measure: Negative outcomes as measured by re-initiation of antibiotic therapy after greater than 48 hours with no antibiotics
timeFrame: 30 days post-randomization
measure: Negative outcomes as measured by number of days patient has a central line
timeFrame: 30 days post-randomization
measure: percent of eligible patients with antibiotic de-escalation
timeFrame: 5 days from initial date of suspected sepsis
measure: Number of patients in whom the safety screen was applied
timeFrame: within 3 days (96 hours) of initial date of suspected sepsis
measure: Number of patients the safety screen excluded from the opt-out procedure
timeFrame: within 3 days (96 hours) of initial date of suspected sepsis
measure: number of eligible patients in whom the opt-out procedure was applied
timeFrame: within 3 days (96 hours) of initial date of suspected sepsis
measure: number of eligible patients in whom the prescriber chose to opt-out
timeFrame: within 3 days (96 hours) of initial date of suspected sepsis
measure: prescriber type
timeFrame: within 3 days (96 hours) of initial date of suspected sepsis
measure: prescribers' reported rationale for opting out
timeFrame: within 3 days (96 hours) of initial date of suspected sepsis
measure: Percent of subjects who received an infectious disease consultation after implementation of the Opt-Out Protocol
timeFrame: 30 days post-randomization
measure: Days of therapy for specific sub-groups of patients, including patients whose physicians elected to opt-out of the intervention
timeFrame: 30 days post-randomization
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Piedmont Atlanta Hospital
state: Georgia
city: Fayetteville
country: United States
facility: Piedmont Fayette Hospital
state: Georgia
city: Newnan
country: United States
facility: Piedmont Newnan Hospital
state: Georgia
city: Boston
country: United States
facility: Harvard Brigham and Women's Hospital
state: Massachusetts
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Lumberton
country: United States
facility: Southeastern Regional Medical Center
state: North Carolina
city: Statesville
country: United States
facility: Iredell Health System
state: North Carolina
city: Wilson
country: United States
facility: Wilson Medical Center
state: North Carolina
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pennsylvania Presbyterian Hospital
state: Pennsylvania
Study officials:
affiliation: Duke University
name: Rebekah Moehring, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.