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
1 other identifier
interventional
4,084
1 country
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2015
Longer than P75 for not_applicable
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 10, 2015
CompletedFirst Posted
Study publicly available on registry
November 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 12, 2019
CompletedFebruary 22, 2019
February 1, 2019
2 years
November 10, 2015
February 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (8)
30-day mortality
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
Clostridium difficile infections
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
Participants will be followed for the duration of hospital stay, an expected average of 1 week
- +3 more secondary outcomes
Study Arms (2)
Control
NO INTERVENTIONPatients will be treated as standard of care.
Antibiotic Stewardship Intervention
EXPERIMENTALPatients 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.
Interventions
The Antibiotic Stewardship Intervention will consist of education, motivating opinion leaders, adapting a pragmatic disease severity classification and prospective audit and feedback.
Eligibility Criteria
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UMC Utrechtlead
Study Sites (12)
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
Related Publications (1)
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.
PMID: 34627499DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marc J.M. Bonten, MD, PhD
UMC Utrecht
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.
Study Record Dates
First Submitted
November 10, 2015
First Posted
November 13, 2015
Study Start
November 1, 2015
Primary Completion
November 1, 2017
Study Completion
February 12, 2019
Last Updated
February 22, 2019
Record last verified: 2019-02