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

Study Overview
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Brief Summary
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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.

Official Title
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Antibiotic Treatment of Community-acquired Pneumonia: a Prospective Comparison of Dutch Guideline Advices.

Conditions
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Community-acquired Pneumonia

Intervention / Treatment
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* Other: Preferred empirical treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Betalactam monotherapy<br>Preferred empirical treatment for patients in this arm is Beta-lactam monotherapy e.g. co-amoxiclav or ceftriaxone | Other: Preferred empirical treatment<br>* 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.<br>|
| Active Comparator: Betalactam combination with macrolide<br>Preferred empirical treatment for patients in this arm is beta-lactam combination therapy with a macrolide e.g. ceftriaxone and erythromycin | Other: Preferred empirical treatment<br>* 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.<br>|
| Active Comparator: Quinolone monotherapy<br>Preferred empirical treatment for patients in this arm is quinolone monotherapy e.g. moxifloxacin or levofloxacin | Other: Preferred empirical treatment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Day 90 Mortality | We will assess all-cause mortality on day 90 from admission from the municipal personal records database | 90 days from admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Side-effects and complications from antibiotic therapy are registered from clinical record | 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. | 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 | 28 days from admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pneumonia, anti-bacterial agents, (cost)efficacy