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

UMC Utrecht

Status: Completed

Conditions: Community-acquired Pneumonia

Treatments: Other: Preferred empirical treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01660204

10-148

80-82310-97-12044 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 2,283 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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2,283 participants in 3 patient groups

Betalactam monotherapy

Active Comparator group

Description:

Preferred empirical treatment for patients in this arm is Beta-lactam monotherapy e.g. co-amoxiclav or ceftriaxone

Treatment:

Other: Preferred empirical treatment

Betalactam combination with macrolide

Active Comparator group

Description:

Preferred empirical treatment for patients in this arm is beta-lactam combination therapy with a macrolide e.g. ceftriaxone and erythromycin

Treatment:

Other: Preferred empirical treatment

Quinolone monotherapy

Active Comparator group

Description:

Preferred empirical treatment for patients in this arm is quinolone monotherapy e.g. moxifloxacin or levofloxacin

Treatment:

Other: Preferred empirical treatment