Increasing Community-acquired Pneumonia Protocol Adherence by Antibiotic Stewardship

Study Overview
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Brief Summary
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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
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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.

Official Title
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Community-acquired Pneumonia: Increasing Protocol Adherence by Antibiotic Stewardship in a Stepped Wedge Cluster- Randomized Trial

Conditions
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Community-acquired Pneumonia

Intervention / Treatment
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* Behavioral: Antibiotic Stewardship Intervention


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Patients will be treated as standard of care. | |
| Experimental: Antibiotic Stewardship Intervention<br>Patients will be treated as standard of care. The Antibiotic Stewardship Intervention will be targeted at the physicians treating the community-acquired pneumonia patients. The purpose of the intervention is to increase prescription concordance with the national guideline for community-acquired pneumonia. | Behavioral: Antibiotic Stewardship Intervention<br>* The Antibiotic Stewardship Intervention will consist of education, motivating opinion leaders, adapting a pragmatic disease severity classification and prospective audit and feedback.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Broad-spectrum antibiotic use | Antibiotic use will be registered during hospital stay | Participants will be followed for the duration of hospital stay, an expected average of 1 week | 
| 90-day mortality | All-cause mortality on day 90 from admission will be assessed from the municipal personal records database | 90-days after hospital admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day mortality | All-cause mortality on day 30 from admission will be assessed from the municipal personal records database | 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 | 
| Clostridium difficile infections | Clostridium difficile polymerase chain reaction (PCR) outcomes will be registered during 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 | Complications of pneumonia during admission are registered from the clinical record | Participants will be followed for the duration of hospital stay, an expected average of 1 week | 
| Hospital readmissions | Hospital readmissions will be registered 30 days after hospital admission | Hospital readmissions within 30 days of hospital admission will be registered | 
| Antibiotic switches | Switches from intravenous to oral (and vice versa) and switches from broad-spectrum to narrow-spectrum (and vice versa) will be registered | Participants will be followed for the duration of hospital stay, an expected average of 1 week | 
| Intensive Care admissions | Intensive Care admissions will be registered during hospital stay | Participants will be followed for the duration of hospital stay, an expected average of 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pneumonia, Antibiotic Stewardship, Stepped wedge, Antibiotic