Antibiotic StewardshipNCT03517007
The DETOURS Trial: De-escalating Empiric Treatment: Opting Out of Rx for Selected Patients With Suspected Sepsis - Opt-Out Protocol Trial
A study testing Opt-Out Protocol in people with Antibiotic Stewardship, run by Duke University at 10 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antibiotic Stewardship
- What is being tested?
- Opt-Out Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 762 participants
- Where
- 10 sitesUnited States
- Study dates
- 12 Sep 2018to 10 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Adult patients who are located in ICU wards.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Piedmont Atlanta Hospital
Atlanta, Georgia, 30309
Harvard Brigham and Women's Hospital
Boston, Massachusetts, 02115
Duke University
Durham, North Carolina, 27710
Piedmont Fayette Hospital
Fayetteville, Georgia, 30214
Southeastern Regional Medical Center
Lumberton, North Carolina, 28358
Piedmont Newnan Hospital
Newnan, Georgia, 30265
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Pennsylvania Presbyterian Hospital
Philadelphia, Pennsylvania, 19104
Iredell Health System
Statesville, North Carolina, 28677
Wilson Medical Center
Wilson, North Carolina, 27893
About this study
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
- Being tested
- Opt-Out Protocol
- Keywords
- antibiotic de-escalation, sepsis, antimicrobial stewardship
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opt-Out ProtocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Opt-Out Protocol |
| Standard of Care | No intervention | Provider continues routine, standard of care on the patient. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days post-randomization
Secondary outcomes (14)
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.
Measured: up to 2 years
Negative outcomes as measured by individual clinical outcome components in the DOOR
Negative outcomes as measured by individual clinical outcome components in the DOOR
Measured: 30 days post-randomization
Negative outcomes as measured by length of hospital stay
Negative outcomes as measured by length of hospital stay
Measured: 30 days post-randomization
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
Measured: 30 days post-randomization
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
Measured: 30 days post-randomization
percent of eligible patients with antibiotic de-escalation
percent of eligible patients with antibiotic de-escalation
Measured: 5 days from initial date of suspected sepsis
Number of patients in whom the safety screen was applied
for patients eligible for assessment of de-escalation
Measured: within 3 days (96 hours) of initial date of suspected sepsis
Number of patients the safety screen excluded from the opt-out procedure
for patients eligible for assessment of de-escalation
Measured: within 3 days (96 hours) of initial date of suspected sepsis
number of eligible patients in whom the opt-out procedure was applied
for patients eligible for assessment of de-escalation
Measured: within 3 days (96 hours) of initial date of suspected sepsis
number of eligible patients in whom the prescriber chose to opt-out
for patients eligible for assessment of de-escalation
Measured: within 3 days (96 hours) of initial date of suspected sepsis
prescriber type
for prescribers who chose to opt out
Measured: within 3 days (96 hours) of initial date of suspected sepsis
prescribers' reported rationale for opting out
for prescribers who chose to opt out
Measured: within 3 days (96 hours) of initial date of suspected sepsis
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
Measured: 30 days post-randomization
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
Measured: 30 days post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2018
- Study start12 Sep 2018
- Primary completion3 Aug 2020
- Study completion10 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Antibiotic StewardshipStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 762 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebekah Moehring, MD, MPH, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03517007
- Sponsor's protocol ID
- Pro00092813
- Status last verified
- Aug 2020
- First submitted
- 3 May 2018
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36167851Yarrington 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.
PubMed 36168480
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The DETOURS Trial: De-escalating Empiric Treatment: Opting Out of Rx for Selected Patients With Suspected Sepsis - Opt-Out Protocol Trial
- ClinicalTrials.gov ID
- NCT03517007
- Acronym / sponsor ID
- Pro00092813
- Conditions
- Antibiotic Stewardship
- Keywords
- antibiotic de-escalation, sepsis, antimicrobial stewardship
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 762 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 12 Sep 2018 (actual)
- Primary completion
- 3 Aug 2020 (actual)
- Study completion
- 10 Aug 2020 (actual)
- First posted
- 7 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opt-Out Protocol | Experimental | Other: Opt-Out ProtocolShould 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. |
| Standard of Care | No intervention | –Provider continues routine, standard of care on the patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Adult patients who are located in ICU wards.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opt-Out ProtocolShould 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 |
Primary outcome
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
14 secondary outcomes
Distributions of DOOR
Time frame: up to 2 years
Negative outcomes as measured by individual clinical outcome components in the DOOR
Time frame: 30 days post-randomization
Negative outcomes as measured by length of hospital stay
Time frame: 30 days post-randomization
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 number of days patient has a central line
Time frame: 30 days post-randomization
percent of eligible patients with antibiotic de-escalation
Time frame: 5 days from initial date of suspected sepsis
Number of patients in whom the safety screen was applied
Time frame: within 3 days (96 hours) of initial date of suspected sepsis
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
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
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
prescriber type
Time frame: within 3 days (96 hours) of initial date of suspected sepsis
prescribers' reported rationale for opting out
Time frame: within 3 days (96 hours) of initial date of suspected sepsis
Percent of subjects who received an infectious disease consultation after implementation of the Opt-Out Protocol
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
Time frame: 30 days post-randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Background: PubMed 36167851Moehring 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.
- Background: PubMed 36168480Yarrington 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebekah Moehring, MD, MPH principal investigator
Duke University
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opt-Out Protocol in people with Antibiotic Stewardship, run by Duke University at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall inpatient plus post-discharge antibacterial Days of Therapy (DOT) as measured by data collection (time frame: 30 days post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03517007, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.