Increasing Community-acquired Pneumonia Protocol Adherence by Antibiotic Stewardship

Not Applicable

Completed

• Conditions: Community-acquired Pneumonia

• Registration Number: NCT02604628
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-11-01
• Study First Submitted: 2015-11-10
• Study First Submitted QC: 2015-11-11
• Study First Posted: 2015-11-13
• Primary Completion: 2017-11-01
• Status Verified: 2019-02
• Study Completion: 2019-02-12
• Last Update Submitted: 2019-02-21
• Last Update Posted: 2019-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4084

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
90-day mortality	90-days after hospital admission	All-cause mortality on day 90 from admission will be assessed from the municipal personal records database
Broad-spectrum antibiotic use	Participants will be followed for the duration of hospital stay, an expected average of 1 week	Antibiotic use will be registered during hospital stay

Secondary Outcome Measures

Name	Time	Method
Clostridium difficile infections	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
Hospital readmissions	Hospital readmissions within 30 days of hospital admission will be registered	Hospital readmissions will be registered 30 days after hospital admission
Antibiotic switches	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
30-day mortality	30-days after hospital admission	All-cause mortality on day 30 from admission will be assessed from the municipal personal records database
Length of hospital stay	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	Complications of pneumonia during admission are registered from the clinical record
Intensive Care admissions	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

Trial Locations

Locations (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

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