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

Antibiotic Stewardship Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03517007
• Other study ID #: Pro00092813
• Status: Completed
• Phase: N/A
• Start date: September 12, 2018
• Est. completion date: August 10, 2020

Study information

• Verified date: August 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 762
• Est. completion date: August 10, 2020
• Est. primary completion date: August 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Antibiotic Stewardship
• Sepsis

Intervention

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.

Locations

Country	Name	City	State
United States	Piedmont Atlanta Hospital	Atlanta	Georgia
United States	Harvard Brigham and Women's Hospital	Boston	Massachusetts
United States	Duke University	Durham	North Carolina
United States	Piedmont Fayette Hospital	Fayetteville	Georgia
United States	Southeastern Regional Medical Center	Lumberton	North Carolina
United States	Piedmont Newnan Hospital	Newnan	Georgia
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Pennsylvania Presbyterian Hospital	Philadelphia	Pennsylvania
United States	Iredell Health System	Statesville	North Carolina
United States	Wilson Medical Center	Wilson	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Negative outcomes as measured by length of hospital stay	Negative outcomes as measured by length of hospital stay	30 days post-randomization
Secondary	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
Secondary	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
Secondary	percent of eligible patients with antibiotic de-escalation	percent of eligible patients with antibiotic de-escalation	5 days from initial date of suspected sepsis
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	prescriber type	for prescribers who chose to opt out	within 3 days (96 hours) of initial date of suspected sepsis
Secondary	prescribers' reported rationale for opting out	for prescribers who chose to opt out	within 3 days (96 hours) of initial date of suspected sepsis
Secondary	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
Secondary	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