An interventional study of Opt-Out Protocol in Antibiotic Stewardship, sponsored by Duke University. Completed at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-06.
Sponsored by Duke University · Not applicable, Interventional, and Prevention
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.
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's enrollment of 762 is above the median of 105 across 896 interventional studies indexed under Sepsis.
Browse Sepsis studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Other: Opt-Out Protocol
Provider continues routine, standard of care on the patient.
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.
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
Time frame: 30 days post-randomization
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.
Time frame: 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
Time frame: 30 days post-randomization
Negative outcomes as measured by length of hospital stay
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
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
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
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
for patients eligible for assessment of de-escalation
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
for patients eligible for assessment of de-escalation
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
for patients eligible for assessment of de-escalation
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
for patients eligible for assessment of de-escalation
Time frame: within 3 days (96 hours) of initial date of suspected sepsis
prescriber type
for prescribers who chose to opt out
Time frame: within 3 days (96 hours) of initial date of suspected sepsis
prescribers' reported rationale for opting out
for prescribers who chose to opt 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
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
.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
Plan to share: No
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Duke University