Clinical trial NCT02604628: Increasing Community-acquired Pneumonia Protocol Adherence by Antibiotic Stewardship
Official title: Community-acquired Pneumonia: Increasing Protocol Adherence by Antibiotic Stewardship in a Stepped Wedge Cluster- Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Community-acquired Pneumonia
Keywords: Pneumonia
Antibiotic Stewardship
Stepped wedge
Antibiotic
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2015-11-13
Enrollment: 4084
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Broad-spectrum antibiotic use
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
measure: 90-day mortality
timeFrame: 90-days after hospital admission
Secondary outcomes:
measure: 30-day mortality
timeFrame: 30-days after hospital admission
measure: Length of hospital stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
measure: Clostridium difficile infections
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
measure: Length of intravenous antibiotic treatment
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
measure: Complications
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
measure: Hospital readmissions
timeFrame: Hospital readmissions within 30 days of hospital admission will be registered
measure: Antibiotic switches
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
measure: Intensive Care admissions
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Other outcomes:
Locations:
city: Alkmaar
country: Netherlands
facility: Noordwest Ziekenhuisgroep
city: Assen
country: Netherlands
facility: Wilhelmina hospital
city: Breda
country: Netherlands
facility: Amphia hospital
city: Eindhoven
country: Netherlands
facility: Catharina hospital
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Hengelo
country: Netherlands
facility: Ziekehuisgroep Twente
city: Hilversum
country: Netherlands
facility: Tergooi
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Utrecht
country: Netherlands
facility: Diakonessenhuis
city: Utrecht
country: Netherlands
facility: UMC Utrecht
city: Veldhoven
country: Netherlands
facility: Maxima Medisch Centrum
city: Zoetermeer
country: Netherlands
facility: Langeland hospital
Study officials:
affiliation: UMC Utrecht
name: Marc J.M. Bonten, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.