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

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

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 Overview

• Status: Completed
• Conditions: Community-acquired Pneumonia
• Intervention / Treatment: Other: Preferred empirical treatment

• Study Type: Interventional
• Enrollment (Actual): 2283
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Alkmaar, Netherlands
    • Medical Center Alkmaar
  • Amsterdam, Netherlands
    • AMC Amsterdam
  • Breda, Netherlands
    • Amphia Hospital Breda
  • Haarlem, Netherlands
    • Kennemer Gasthuis
  • Hoofddorp, Netherlands
    • Spaarne Hospital
  • Utrecht, Netherlands
    • UMC Utrecht
  • Utrecht, Netherlands
    • Diakonessenhuis Utrecht

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Betalactam monotherapy; Preferred empirical treatment for patients in this arm is Beta-lactam monotherapy e.g. co-amoxiclav or ceftriaxone	Other: Preferred empirical treatment; 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.
Active Comparator: Betalactam combination with macrolide; 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; 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.
Active Comparator: Quinolone monotherapy; Preferred empirical treatment for patients in this arm is quinolone monotherapy e.g. moxifloxacin or levofloxacin	Other: Preferred empirical treatment; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: UMC Utrecht
• Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development
• Investigators: Principal Investigator: Marc J. Bonten, MD PhD, UMC Utrecht

Publications and helpful links

General Publications

• Postma DF, Spitoni C, van Werkhoven CH, van Elden LJR, Oosterheert JJ, Bonten MJM. Cardiac events after macrolides or fluoroquinolones in patients hospitalized for community-acquired pneumonia: post-hoc analysis of a cluster-randomized trial. BMC Infect Dis. 2019 Jan 7;19(1):17. doi: 10.1186/s12879-018-3630-7.
• van Werkhoven CH, Postma DF, Mangen MJ, Oosterheert JJ, Bonten MJ; CAP-START study group. Cost-effectiveness of antibiotic treatment strategies for community-acquired pneumonia: results from a cluster randomized cross-over trial. BMC Infect Dis. 2017 Jan 10;17(1):52. doi: 10.1186/s12879-016-2179-6.
• Postma DF, van Werkhoven CH, van Elden LJ, Thijsen SF, Hoepelman AI, Kluytmans JA, Boersma WG, Compaijen CJ, van der Wall E, Prins JM, Oosterheert JJ, Bonten MJ; CAP-START Study Group. Antibiotic treatment strategies for community-acquired pneumonia in adults. N Engl J Med. 2015 Apr 2;372(14):1312-23. doi: 10.1056/NEJMoa1406330.
• van Werkhoven CH, Postma DF, Oosterheert JJ, Bonten MJ. Antibiotic treatment of moderate-severe community-acquired pneumonia: design and rationale of a multicentre cluster-randomised cross-over trial. Neth J Med. 2014 Apr;72(3):170-8.

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: May 2, 2012
• First Submitted That Met QC Criteria: August 3, 2012
• First Posted (Estimate): August 8, 2012

Study Record Updates

• Last Update Posted (Estimate): April 23, 2014
• Last Update Submitted That Met QC Criteria: April 22, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: pneumonia, anti-bacterial agents, (cost)efficacy
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia
• Other Study ID Numbers: 10-148; 80-82310-97-12044 (Other Grant/Funding Number: ZonMw)