Community-acquired Pneumonia
Conditions
Keywords
Pneumonia, Antibiotic Stewardship, Stepped wedge, Antibiotic
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.
Interventions
BEHAVIORALAntibiotic Stewardship Intervention
The Antibiotic Stewardship Intervention will consist of education, motivating opinion leaders, adapting a pragmatic disease severity classification and prospective audit and feedback.
Sponsors
UMC Utrecht
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Broad-spectrum antibiotic use | Participants will be followed for the duration of hospital stay, an expected average of 1 week | Antibiotic use will be registered during hospital stay |
| 90-day mortality | 90-days after hospital admission | All-cause mortality on day 90 from admission will be assessed from the municipal personal records database |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clostridium difficile infections | Participants will be followed for the duration of hospital stay, an expected average of 1 week | Clostridium difficile polymerase chain reaction (PCR) outcomes will be registered during hospital stay |
| 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 | Complications of pneumonia during admission are registered from the clinical record |
| 30-day mortality | 30-days after hospital admission | All-cause mortality on day 30 from admission will be assessed from the municipal personal records database |
| Antibiotic switches | Participants will be followed for the duration of hospital stay, an expected average of 1 week | Switches from intravenous to oral (and vice versa) and switches from broad-spectrum to narrow-spectrum (and vice versa) will be registered |
| Intensive Care admissions | Participants will be followed for the duration of hospital stay, an expected average of 1 week | Intensive Care admissions will be registered during hospital stay |
| Hospital readmissions | Hospital readmissions within 30 days of hospital admission will be registered | Hospital readmissions will be registered 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 | — |
Countries
Netherlands
Outcome results
None listed