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

UMC Utrecht

Status: Completed

Conditions: Community-acquired Pneumonia

Treatments: Behavioral: Antibiotic Stewardship Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02604628

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Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,084 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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4,084 participants in 2 patient groups

Control

No Intervention group

Description:

Patients will be treated as standard of care.

Antibiotic Stewardship Intervention

Experimental group

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.

Treatment:

Behavioral: Antibiotic Stewardship Intervention