Increasing Community-acquired Pneumonia Protocol Adherence by Antibiotic Stewardship (CAP-PACT)

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

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.

Study Overview

• Status: Completed
• Conditions: Community-acquired Pneumonia
• Intervention / Treatment: Behavioral: Antibiotic Stewardship Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 4084
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Alkmaar, Netherlands
    • Noordwest Ziekenhuisgroep
  • Assen, Netherlands
    • Wilhelmina hospital
  • Breda, Netherlands
    • Amphia Hospital
  • Eindhoven, Netherlands
    • Catharina Hospital
  • Enschede, Netherlands
    • Medisch Spectrum Twente
  • Hengelo, Netherlands
    • Ziekehuisgroep Twente
  • Hilversum, Netherlands
    • Tergooi
  • Rotterdam, Netherlands
    • Erasmus MC
  • Utrecht, Netherlands
    • UMC Utrecht
  • Utrecht, Netherlands
    • Diakonessenhuis
  • Veldhoven, Netherlands
    • Maxima Medisch Centrum
  • Zoetermeer, Netherlands
    • Langeland hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control; Patients will be treated as standard of care.
EXPERIMENTAL: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of intravenous antibiotic treatment		Participants will be followed for the duration of hospital stay, an expected average of 1 week
Length of hospital stay		Participants will be followed for the duration of hospital stay, an expected average of 1 week
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
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
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

Collaborators and Investigators

• Sponsor: UMC Utrecht
• Investigators: Principal Investigator: Marc J.M. Bonten, MD, PhD, UMC Utrecht

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2015
• Primary Completion (ACTUAL): November 1, 2017
• Study Completion (ACTUAL): February 12, 2019

Study Registration Dates

• First Submitted: November 10, 2015
• First Submitted That Met QC Criteria: November 11, 2015
• First Posted (ESTIMATE): November 13, 2015

Study Record Updates

• Last Update Posted (ACTUAL): February 22, 2019
• Last Update Submitted That Met QC Criteria: February 21, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Pneumonia; Antibiotic; Antibiotic Stewardship; Stepped wedge
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: 1 (Other Identifier: Mobile Health and Wellness Program)