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

Duke University

Status: Completed

Conditions: Antibiotic Stewardship

Treatments: Other: Opt-Out Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT03517007

Pro00092813

Details and patient eligibility

About

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.

Enrollment: 762 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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762 participants in 2 patient groups

Opt-Out Protocol

Experimental group

Description:

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.

Treatment:

Other: Opt-Out Protocol

Standard of Care

No Intervention group

Description:

Provider continues routine, standard of care on the patient.