Community-Acquired Pneumonia - Study on the Initial Treatment With Antibiotics of Lower Respiratory Tract Infections

UMC Utrecht2,283 enrolled

Overview

The purpose of this study is to compare the cost(effectiveness) of three existing antibiotic strategies for patients with community-acquired pneumonia admitted to the hospital, but not the ICU.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

2,283

Conditions

Community-acquired Pneumonia

Interventions

Preferred empirical treatmentOTHER

The investigators are using a cluster-randomized cross-over design for preferred empirical treatment. One of the 3 treatment arms is used as preferred empirical therapy during a period of 4 consecutive months, after which preferred treatment will rotate to 1 of the other 2 regimens. The order of change is randomised per hospital, thereby controlling for inter-hospital variables and minimizing seasonal influences.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * All patients admitted to one of the participating hospitals needing treatment for CAP, not being admitted to the ICU are eligible for study inclusion. * Admission is defined as hospital stay for more than 24 hours. Exclusion Criteria: * Patients who are readmitted with CAP within 2 weeks after a previous episode are not eligible. * Patients with cystic fibrosis are not eligible.

Locations (7)

Medical Center Alkmaar

Alkmaar, Netherlands

AMC Amsterdam

Amsterdam, Netherlands

Amphia Hospital Breda

Breda, Netherlands

Kennemer Gasthuis

Haarlem, Netherlands

Outcomes

Primary Outcomes

Day 90 Mortality

We will assess all-cause mortality on day 90 from admission from the municipal personal records database

Time frame: 90 days from admission

Secondary Outcomes

Length of intravenous antibiotic treatment

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

Tolerability

Side-effects and complications from antibiotic therapy are registered from clinical record

Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week

Complications

Complications of pneumonia during admission are registered from clinical record.

Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week

Health care costs and non-health care costs

Health care costs and non-health care costs are assessed using a short questionnaire 28 days from admission

Time frame: 28 days from admission

Data from ClinicalTrials.gov

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