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

Not Applicable

Completed

• Conditions: Community-acquired Pneumonia
• Interventions: Other: Preferred empirical treatment

• Registration Number: NCT01660204
• Lead Sponsor: UMC Utrecht

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2012-05-02
• Study First Submitted QC: 2012-08-03
• Study First Posted: 2012-08-08
• Primary Completion: 2013-11
• Study Completion: 2014-01
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-22
• Last Update Posted: 2014-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2283

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Betalactam monotherapy	Preferred empirical treatment	Preferred empirical treatment for patients in this arm is Beta-lactam monotherapy e.g. co-amoxiclav or ceftriaxone
Betalactam combination with macrolide	Preferred empirical treatment	Preferred empirical treatment for patients in this arm is beta-lactam combination therapy with a macrolide e.g. ceftriaxone and erythromycin
Quinolone monotherapy	Preferred empirical treatment	Preferred empirical treatment for patients in this arm is quinolone monotherapy e.g. moxifloxacin or levofloxacin

Primary Outcome Measures

Name	Time	Method
Day 90 Mortality	90 days from admission	We will assess all-cause mortality on day 90 from admission from the municipal personal records database

Secondary Outcome Measures

Name	Time	Method
Length of intravenous antibiotic treatment	Participants will be followed for the duration of hospital stay, an expected average of 1 week
Length of hospital stay	Participants will be followed for the duration of hospital stay, an expected average of 1 week
Tolerability	Participants will be followed for the duration of hospital stay, an expected average of 1 week	Side-effects and complications from antibiotic therapy are registered from clinical record
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 clinical record.
Health care costs and non-health care costs	28 days from admission	Health care costs and non-health care costs are assessed using a short questionnaire 28 days from admission

Trial Locations

Locations (7)

Amphia Hospital Breda; 🇳🇱 Breda, Netherlands

Spaarne Hospital; 🇳🇱 Hoofddorp, Netherlands

Medical Center Alkmaar; 🇳🇱 Alkmaar, Netherlands

AMC Amsterdam; 🇳🇱 Amsterdam, Netherlands

Kennemer Gasthuis; 🇳🇱 Haarlem, Netherlands

Diakonessenhuis Utrecht; 🇳🇱 Utrecht, Netherlands

UMC Utrecht; 🇳🇱 Utrecht, Netherlands