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

Primary Purpose

Community-acquired Pneumonia

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Antibiotic Stewardship Intervention
Sponsored by
UMC Utrecht
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Community-acquired Pneumonia focused on measuring Pneumonia, Antibiotic Stewardship, Stepped wedge, Antibiotic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Noordwest Ziekenhuisgroep
  • Wilhelmina hospital
  • Amphia hospital
  • Catharina hospital
  • Medisch Spectrum Twente
  • Ziekehuisgroep Twente
  • Tergooi
  • Erasmus MC
  • Diakonessenhuis
  • UMC Utrecht
  • Maxima Medisch Centrum
  • Langeland hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Antibiotic Stewardship Intervention

Arm Description

Patients will be treated as standard of care.

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.

Outcomes

Primary Outcome Measures

Broad-spectrum antibiotic use
Antibiotic use will be registered during hospital stay
90-day mortality
All-cause mortality on day 90 from admission will be assessed from the municipal personal records database

Secondary Outcome Measures

30-day mortality
All-cause mortality on day 30 from admission will be assessed from the municipal personal records database
Length of hospital stay
Clostridium difficile infections
Clostridium difficile polymerase chain reaction (PCR) outcomes will be registered during hospital stay
Length of intravenous antibiotic treatment
Complications
Complications of pneumonia during admission are registered from the clinical record
Hospital readmissions
Hospital readmissions will be registered 30 days after hospital admission
Antibiotic switches
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
Intensive Care admissions will be registered during hospital stay

Full Information

First Posted
November 10, 2015
Last Updated
February 21, 2019
Sponsor
UMC Utrecht
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1. Study Identification

Unique Protocol Identification Number
NCT02604628
Brief Title
Increasing Community-acquired Pneumonia Protocol Adherence by Antibiotic Stewardship
Acronym
CAP-PACT
Official Title
Community-acquired Pneumonia: Increasing Protocol Adherence by Antibiotic Stewardship in a Stepped Wedge Cluster- Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
November 1, 2015 (Actual)
Primary Completion Date
November 1, 2017 (Actual)
Study Completion Date
February 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UMC Utrecht

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community-acquired Pneumonia
Keywords
Pneumonia, Antibiotic Stewardship, Stepped wedge, Antibiotic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4084 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients will be treated as standard of care.
Arm Title
Antibiotic Stewardship Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Antibiotic Stewardship Intervention
Intervention Description
The Antibiotic Stewardship Intervention will consist of education, motivating opinion leaders, adapting a pragmatic disease severity classification and prospective audit and feedback.
Primary Outcome Measure Information:
Title
Broad-spectrum antibiotic use
Description
Antibiotic use will be registered during hospital stay
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 1 week
Title
90-day mortality
Description
All-cause mortality on day 90 from admission will be assessed from the municipal personal records database
Time Frame
90-days after hospital admission
Secondary Outcome Measure Information:
Title
30-day mortality
Description
All-cause mortality on day 30 from admission will be assessed from the municipal personal records database
Time Frame
30-days after hospital admission
Title
Length of hospital stay
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 1 week
Title
Clostridium difficile infections
Description
Clostridium difficile polymerase chain reaction (PCR) outcomes will be registered during hospital stay
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 1 week
Title
Length of intravenous antibiotic treatment
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 1 week
Title
Complications
Description
Complications of pneumonia during admission are registered from the clinical record
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 1 week
Title
Hospital readmissions
Description
Hospital readmissions will be registered 30 days after hospital admission
Time Frame
Hospital readmissions within 30 days of hospital admission will be registered
Title
Antibiotic switches
Description
Switches from intravenous to oral (and vice versa) and switches from broad-spectrum to narrow-spectrum (and vice versa) will be registered
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 1 week
Title
Intensive Care admissions
Description
Intensive Care admissions will be registered during hospital stay
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc J.M. Bonten, MD, PhD
Organizational Affiliation
UMC Utrecht
Official's Role
Principal Investigator
Facility Information:
Facility Name
Noordwest Ziekenhuisgroep
City
Alkmaar
Country
Netherlands
Facility Name
Wilhelmina hospital
City
Assen
Country
Netherlands
Facility Name
Amphia hospital
City
Breda
Country
Netherlands
Facility Name
Catharina hospital
City
Eindhoven
Country
Netherlands
Facility Name
Medisch Spectrum Twente
City
Enschede
Country
Netherlands
Facility Name
Ziekehuisgroep Twente
City
Hengelo
Country
Netherlands
Facility Name
Tergooi
City
Hilversum
Country
Netherlands
Facility Name
Erasmus MC
City
Rotterdam
Country
Netherlands
Facility Name
Diakonessenhuis
City
Utrecht
Country
Netherlands
Facility Name
UMC Utrecht
City
Utrecht
Country
Netherlands
Facility Name
Maxima Medisch Centrum
City
Veldhoven
Country
Netherlands
Facility Name
Langeland hospital
City
Zoetermeer
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
34627499
Citation
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.
Results Reference
derived

Learn more about this trial

Increasing Community-acquired Pneumonia Protocol Adherence by Antibiotic Stewardship

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