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

Primary Purpose

Community-acquired Pneumonia

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Preferred empirical treatment
Sponsored by
UMC Utrecht
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Community-acquired Pneumonia focused on measuring pneumonia, anti-bacterial agents, (cost)efficacy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Medical Center Alkmaar
  • AMC Amsterdam
  • Amphia Hospital Breda
  • Kennemer Gasthuis
  • Spaarne Hospital
  • Diakonessenhuis Utrecht
  • UMC Utrecht

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Betalactam monotherapy

Betalactam combination with macrolide

Quinolone monotherapy

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Length of intravenous antibiotic treatment
Length of hospital stay
Tolerability
Side-effects and complications from antibiotic therapy are registered from clinical record
Complications
Complications of pneumonia during admission are registered from clinical record.
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

Full Information

First Posted
May 2, 2012
Last Updated
April 22, 2014
Sponsor
UMC Utrecht
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT01660204
Brief Title
Community-Acquired Pneumonia - Study on the Initial Treatment With Antibiotics of Lower Respiratory Tract Infections
Acronym
CAP-START
Official Title
Antibiotic Treatment of Community-acquired Pneumonia: a Prospective Comparison of Dutch Guideline Advices.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UMC Utrecht
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community-acquired Pneumonia
Keywords
pneumonia, anti-bacterial agents, (cost)efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2283 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Betalactam monotherapy
Arm Type
Active Comparator
Arm Description
Preferred empirical treatment for patients in this arm is Beta-lactam monotherapy e.g. co-amoxiclav or ceftriaxone
Arm Title
Betalactam combination with macrolide
Arm Type
Active Comparator
Arm Description
Preferred empirical treatment for patients in this arm is beta-lactam combination therapy with a macrolide e.g. ceftriaxone and erythromycin
Arm Title
Quinolone monotherapy
Arm Type
Active Comparator
Arm Description
Preferred empirical treatment for patients in this arm is quinolone monotherapy e.g. moxifloxacin or levofloxacin
Intervention Type
Other
Intervention Name(s)
Preferred empirical treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Day 90 Mortality
Description
We will assess all-cause mortality on day 90 from admission from the municipal personal records database
Time Frame
90 days from admission
Secondary Outcome Measure Information:
Title
Length of intravenous antibiotic treatment
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 1 week
Title
Length of hospital stay
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 1 week
Title
Tolerability
Description
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
Title
Complications
Description
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
Title
Health care costs and non-health care costs
Description
Health care costs and non-health care costs are assessed using a short questionnaire 28 days from admission
Time Frame
28 days from admission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc J. Bonten, MD PhD
Organizational Affiliation
UMC Utrecht
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Center Alkmaar
City
Alkmaar
Country
Netherlands
Facility Name
AMC Amsterdam
City
Amsterdam
Country
Netherlands
Facility Name
Amphia Hospital Breda
City
Breda
Country
Netherlands
Facility Name
Kennemer Gasthuis
City
Haarlem
Country
Netherlands
Facility Name
Spaarne Hospital
City
Hoofddorp
Country
Netherlands
Facility Name
Diakonessenhuis Utrecht
City
Utrecht
Country
Netherlands
Facility Name
UMC Utrecht
City
Utrecht
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
30612559
Citation
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.
Results Reference
derived
PubMed Identifier
28068956
Citation
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.
Results Reference
derived
PubMed Identifier
25830421
Citation
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.
Results Reference
derived
PubMed Identifier
24846935
Citation
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.
Results Reference
derived

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

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