Increasing Community-acquired Pneumonia Protocol Adherence by Antibiotic Stewardship

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02604628
• Date of registration: 10/11/2015
• Prospective Registration: No
• Primary sponsor: UMC Utrecht
• Public title: Increasing Community-acquired Pneumonia Protocol Adherence by Antibiotic Stewardship CAP-PACT
• Scientific title: Community-acquired Pneumonia: Increasing Protocol Adherence by Antibiotic Stewardship in a Stepped Wedge Cluster- Randomized Trial
• Date of first enrolment: November 1, 2015
• Target sample size: 4084
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02604628
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Netherlands

Contacts

• Name: Marc J.M. Bonten, MD, PhD
• Affiliation: UMC Utrecht

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Community-acquired Pneumonia

Intervention(s)

Behavioral: Antibiotic Stewardship Intervention

Primary Outcome(s)

90-day mortality [Time Frame: 90-days after hospital admission]

Broad-spectrum antibiotic use [Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week]

Secondary Outcome(s)

Antibiotic switches [Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week]

Complications [Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week]

Length of intravenous antibiotic treatment [Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week]

Clostridium difficile infections [Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week]

Length of hospital stay [Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week]

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

30-day mortality [Time Frame: 30-days after hospital admission]

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

Secondary ID(s)

1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors