Increasing Community-acquired Pneumonia Protocol Adherence by Antibiotic Stewardship

UMC Utrecht4,084 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

4,084

Conditions

Community-acquired Pneumonia

Interventions

Antibiotic Stewardship InterventionBEHAVIORAL

The Antibiotic Stewardship Intervention will consist of education, motivating opinion leaders, adapting a pragmatic disease severity classification and prospective audit and feedback.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (12)

Noordwest Ziekenhuisgroep

Alkmaar, Netherlands

Wilhelmina hospital

Assen, Netherlands

Amphia hospital

Breda, Netherlands

Catharina hospital

Eindhoven, Netherlands

Outcomes

Primary Outcomes

Broad-spectrum antibiotic use

Antibiotic use will be registered during hospital stay

Time frame: 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

Time frame: 90-days after hospital admission

Secondary Outcomes

30-day mortality

All-cause mortality on day 30 from admission will be assessed from the municipal personal records database

Time frame: 30-days after hospital admission

Length of hospital stay

Time frame: 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

Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week

Length of intravenous antibiotic treatment

Time frame: 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

Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week

Hospital readmissions

Data from ClinicalTrials.gov

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