Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Patients will be treated as standard of care. | |
| Antibiotic Stewardship Intervention | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antibiotic Stewardship Intervention | Behavioral | The Antibiotic Stewardship Intervention will consist of education, motivating opinion leaders, adapting a pragmatic disease severity classification and prospective audit and feedback. |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marc J.M. Bonten, MD, PhD | UMC Utrecht | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Noordwest Ziekenhuisgroep | Alkmaar | Netherlands | ||||
| Wilhelmina hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34627499 | Derived | Schweitzer VA, van Heijl I, Boersma WG, Rozemeijer W, Verduin K, Grootenboers MJ, Sankatsing SUC, van der Bij AK, de Bruijn W, Ammerlaan HSM, Overdevest I, Roorda-van der Vegt JMM, Engel-Dettmers EM, Ayuketah-Ekokobe FE, Haeseker MB, Dorigo-Zetsma JW, van der Linden PD, Boel CHE, Oosterheert JJ, van Werkhoven CH, Bonten MJM; CAP-PACT Study Group. Narrow-spectrum antibiotics for community-acquired pneumonia in Dutch adults (CAP-PACT): a cross-sectional, stepped-wedge, cluster-randomised, non-inferiority, antimicrobial stewardship intervention trial. Lancet Infect Dis. 2022 Feb;22(2):274-283. doi: 10.1016/S1473-3099(21)00255-3. Epub 2021 Oct 7. |
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 6, 2018 | Jul 6, 2018 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| Assen |
| Netherlands |
| Amphia hospital | Breda | Netherlands |
| Catharina hospital | Eindhoven | Netherlands |
| Medisch Spectrum Twente | Enschede | Netherlands |
| Ziekehuisgroep Twente | Hengelo | Netherlands |
| Tergooi | Hilversum | Netherlands |
| Erasmus MC | Rotterdam | Netherlands |
| Diakonessenhuis | Utrecht | Netherlands |
| UMC Utrecht | Utrecht | Netherlands |
| Maxima Medisch Centrum | Veldhoven | Netherlands |
| Langeland hospital | Zoetermeer | Netherlands |
| SAP_000.pdf |
| ID | Term |
|---|---|
| D000098968 | Community-Acquired Pneumonia |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D017714 | Community-Acquired Infections |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| D008171 | Lung Diseases |
Not provided
Not provided