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Completed

NCT Number: NCT03517007

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.

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Key information

Conditions

Antibiotic Stewardship Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Piedmont Atlanta Hospital, Atlanta, Georgia, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Overall inpatient plus post-discharge antibacterial Days of Therapy (DOT) as measured by data collection

    Time frame: 30 days post-randomization

    Overall inpatient plus post-discharge antibacterial Days of Therapy (DOT) as measured by data collection

Secondary outcomes

  1. Distributions of DOOR

    Time frame: up to 2 years

    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.

  2. Negative outcomes as measured by individual clinical outcome components in the DOOR

    Time frame: 30 days post-randomization

    Negative outcomes as measured by individual clinical outcome components in the DOOR

  3. Negative outcomes as measured by length of hospital stay

    Time frame: 30 days post-randomization

    Negative outcomes as measured by length of hospital stay

  4. Negative outcomes as measured by re-initiation of antibiotic therapy after greater than 48 hours with no antibiotics

    Time frame: 30 days post-randomization

    Negative outcomes as measured by re-initiation of antibiotic therapy after greater than 48 hours with no antibiotics

  5. Negative outcomes as measured by number of days patient has a central line

    Time frame: 30 days post-randomization

    Negative outcomes as measured by number of days patient has a central line

  6. percent of eligible patients with antibiotic de-escalation

    Time frame: 5 days from initial date of suspected sepsis

    percent of eligible patients with antibiotic de-escalation

  7. Number of patients in whom the safety screen was applied

    Time frame: within 3 days (96 hours) of initial date of suspected sepsis

    for patients eligible for assessment of de-escalation

  8. Number of patients the safety screen excluded from the opt-out procedure

    Time frame: within 3 days (96 hours) of initial date of suspected sepsis

    for patients eligible for assessment of de-escalation

  9. number of eligible patients in whom the opt-out procedure was applied

    Time frame: within 3 days (96 hours) of initial date of suspected sepsis

    for patients eligible for assessment of de-escalation

  10. number of eligible patients in whom the prescriber chose to opt-out

    Time frame: within 3 days (96 hours) of initial date of suspected sepsis

    for patients eligible for assessment of de-escalation

  11. prescriber type

    Time frame: within 3 days (96 hours) of initial date of suspected sepsis

    for prescribers who chose to opt out

  12. prescribers' reported rationale for opting out

    Time frame: within 3 days (96 hours) of initial date of suspected sepsis

    for prescribers who chose to opt out

  13. Percent of subjects who received an infectious disease consultation after implementation of the Opt-Out Protocol

    Time frame: 30 days post-randomization

    Percent of subjects who received an infectious disease consultation after implementation of the Opt-Out Protocol

  14. Days of therapy for specific sub-groups of patients, including patients whose physicians elected to opt-out of the intervention

    Time frame: 30 days post-randomization

    .Days of therapy for specific sub-groups of patients, including patients whose physicians elected to opt-out of the intervention

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 7, 2018
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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