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Trial record 61 of 257 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND broad

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

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ClinicalTrials.gov Identifier: NCT02604628
Recruitment Status : Completed
First Posted : November 13, 2015
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
MJM Bonten, UMC Utrecht

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.

Condition or disease Intervention/treatment Phase
Community-acquired Pneumonia Behavioral: Antibiotic Stewardship Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4084 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Community-acquired Pneumonia: Increasing Protocol Adherence by Antibiotic Stewardship in a Stepped Wedge Cluster- Randomized Trial
Actual Study Start Date : November 1, 2015
Actual Primary Completion Date : November 1, 2017
Actual Study Completion Date : February 12, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Broad-spectrum antibiotic use [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week ]
    Antibiotic use will be registered during hospital stay

  2. 90-day mortality [ Time Frame: 90-days after hospital admission ]
    All-cause mortality on day 90 from admission will be assessed from the municipal personal records database


Secondary Outcome Measures :
  1. 30-day mortality [ Time Frame: 30-days after hospital admission ]
    All-cause mortality on day 30 from admission will be assessed from the municipal personal records database

  2. Length of hospital stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week ]
  3. Clostridium difficile infections [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week ]
    Clostridium difficile polymerase chain reaction (PCR) outcomes will be registered during hospital stay

  4. Length of intravenous antibiotic treatment [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week ]
  5. Complications [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week ]
    Complications of pneumonia during admission are registered from the clinical record

  6. Hospital readmissions [ Time Frame: Hospital readmissions within 30 days of hospital admission will be registered ]
    Hospital readmissions will be registered 30 days after hospital admission

  7. Antibiotic switches [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week ]
    Switches from intravenous to oral (and vice versa) and switches from broad-spectrum to narrow-spectrum (and vice versa) will be registered

  8. Intensive Care admissions [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week ]
    Intensive Care admissions will be registered during hospital stay



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02604628


Locations
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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, Netherlands
Sponsors and Collaborators
UMC Utrecht
Investigators
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Principal Investigator: Marc J.M. Bonten, MD, PhD UMC Utrecht
  Study Documents (Full-Text)

Documents provided by MJM Bonten, UMC Utrecht:
Statistical Analysis Plan  [PDF] July 6, 2018


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Responsible Party: MJM Bonten, Prof., UMC Utrecht
ClinicalTrials.gov Identifier: NCT02604628     History of Changes
Other Study ID Numbers: 1
First Posted: November 13, 2015    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019
Keywords provided by MJM Bonten, UMC Utrecht:
Pneumonia
Antibiotic Stewardship
Stepped wedge
Antibiotic
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents