Increasing Community-acquired Pneumonia Protocol Adherence by Antibiotic Stewardship

NCT ID: NCT02604628

Last Updated: 2019-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4084 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-01
• Study Completion Date: 2019-02-12

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.

Conditions

Community-acquired Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

Patients will be treated as standard of care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Antibiotic Stewardship Intervention

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.

Group Type: EXPERIMENTAL

Antibiotic Stewardship Intervention

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UMC Utrecht

OTHER

Sponsor Role: lead

Responsible Party

MJM Bonten

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marc J.M. Bonten, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

Locations

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, , Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 34627499 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

1

Identifier Type: -

Identifier Source: org_study_id