Community-acquired Pneumonia: Increasing Protocol Adherence by Antibiotic Stewardship in a Stepped Wedge Cluster- Randomized Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Community-acquired Pneumonia
- Sponsor
- UMC Utrecht
- Enrollment
- 4084
- Locations
- 12
- Primary Endpoint
- 90-day mortality
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to determine the effect of a multifaceted antibiotic stewardship intervention on protocol adherence of moderate-severe community-acquired pneumonia.
Detailed Description
The purpose of the study is to show a decrease in broad-spectrum antibiotics with a non-inferiority in 90-day mortality. Hospitals with a pre-intervention protocol adherence of \>70% are excluded from the primary analysis. Primary analysis will be done with a mixed effects model with a random effects for clusters and time. Crude outcomes and outcomes adjusted for potential confounders will be reported. Primary analysis will be tested one-sided for a decrease in mortality. Secondary analysis to test two-sided for mortality will be performed.
Investigators
MJM Bonten
Prof.
UMC Utrecht
Eligibility Criteria
Inclusion Criteria
- •Patients diagnosed with CAP who get admitted to a non-ICU department are eligible for inclusion.
Exclusion Criteria
- •Patients aged below 18 years
- •Residence in a nursing home or long-term care facility in the last 14 days
- •Patients hospitalized in an acute care hospital for two or more days in the last 14 days
- •Patients with a history of Cystic Fibrosis
- •Patients with immunodeficiency, defined as having one or more of the following criteria:
- •HIV infection with a last CD4 count of \<300//μL
- •Cytotoxic chemotherapy or radiotherapy in the previous 3 months
- •Chronic hemodialysis \> 3 months
- •History of receiving an organ or bone marrow transplant
- •Using immunosuppressive therapy, include corticosteroid treatment only when dosage is high (\>0,5mg/kg/day) for a longer period of time (\>14 days)
Outcomes
Primary Outcomes
90-day mortality
Time Frame: 90-days after hospital admission
All-cause mortality on day 90 from admission will be assessed from the municipal personal records database
Broad-spectrum antibiotic use
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Antibiotic use will be registered during hospital stay
Secondary Outcomes
- Clostridium difficile infections(Participants will be followed for the duration of hospital stay, an expected average of 1 week)
- Hospital readmissions(Hospital readmissions within 30 days of hospital admission will be registered)
- Antibiotic switches(Participants will be followed for the duration of hospital stay, an expected average of 1 week)
- 30-day mortality(30-days after hospital admission)
- Length of hospital stay(Participants will be followed for the duration of hospital stay, an expected average of 1 week)
- Length of intravenous antibiotic treatment(Participants will be followed for the duration of hospital stay, an expected average of 1 week)
- Complications(Participants will be followed for the duration of hospital stay, an expected average of 1 week)
- Intensive Care admissions(Participants will be followed for the duration of hospital stay, an expected average of 1 week)