Increasing Community-acquired Pneumonia Protocol Adherence by Antibiotic Stewardship

Community-acquired Pneumonia Clinical Trial

— CAP-PACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02604628
• Other study ID #: 1
• Status: Completed
• Phase: N/A
• Start date: November 1, 2015
• Est. completion date: February 12, 2019

Study information

• Verified date: February 2019
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4084
• Est. completion date: February 12, 2019
• Est. primary completion date: November 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Community-acquired Pneumonia
• Pneumonia

Intervention

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

Locations

Country	Name	City	State
Netherlands	Noordwest Ziekenhuisgroep	Alkmaar
Netherlands	Wilhelmina hospital	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

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Length of hospital stay		Participants will be followed for the duration of hospital stay, an expected average of 1 week
Secondary	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
Secondary	Length of intravenous antibiotic treatment		Participants will be followed for the duration of hospital stay, an expected average of 1 week
Secondary	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
Secondary	Hospital readmissions	Hospital readmissions will be registered 30 days after hospital admission	Hospital readmissions within 30 days of hospital admission will be registered
Secondary	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
Secondary	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