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Completed

NCT Number: NCT02604628

Increasing Community-acquired Pneumonia Protocol Adherence by Antibiotic Stewardship

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.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Noordwest Ziekenhuisgroep, Alkmaar, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Antibiotic Stewardship Intervention

Behavioral

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Registry information

Official study title

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

Acronym: CAP-PACT

Important dates

Study start
2015
Primary completion
2017
Study completion
2019
First posted
Nov 13, 2015
Registry last updated
Feb 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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