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

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ClinicalTrials.gov Identifier: NCT01660204
Recruitment Status : Completed
First Posted : August 8, 2012
Last Update Posted : April 23, 2014
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
MJM Bonten, 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.

Condition or disease Intervention/treatment Phase
Community-acquired Pneumonia Other: Preferred empirical treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2283 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Antibiotic Treatment of Community-acquired Pneumonia: a Prospective Comparison of Dutch Guideline Advices.
Study Start Date : February 2011
Actual Primary Completion Date : November 2013
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Day 90 Mortality [ Time Frame: 90 days from admission ]
    We will assess all-cause mortality on day 90 from admission from the municipal personal records database


Secondary Outcome Measures :
  1. Length of intravenous antibiotic treatment [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week ]
  2. Length of hospital stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week ]
  3. Tolerability [ Time Frame: 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

  4. Complications [ Time Frame: 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.

  5. Health care costs and non-health care costs [ Time Frame: 28 days from admission ]
    Health care costs and non-health care costs are assessed using a short questionnaire 28 days from admission



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01660204


Locations
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Netherlands
Medical Center Alkmaar
Alkmaar, Netherlands
AMC Amsterdam
Amsterdam, Netherlands
Amphia Hospital Breda
Breda, Netherlands
Kennemer Gasthuis
Haarlem, Netherlands
Spaarne Hospital
Hoofddorp, Netherlands
Diakonessenhuis Utrecht
Utrecht, Netherlands
UMC Utrecht
Utrecht, Netherlands
Sponsors and Collaborators
UMC Utrecht
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
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Principal Investigator: Marc J. Bonten, MD PhD UMC Utrecht

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: MJM Bonten, Professor, UMC Utrecht
ClinicalTrials.gov Identifier: NCT01660204     History of Changes
Other Study ID Numbers: 10-148
80-82310-97-12044 ( Other Grant/Funding Number: ZonMw )
First Posted: August 8, 2012    Key Record Dates
Last Update Posted: April 23, 2014
Last Verified: April 2014

Keywords provided by MJM Bonten, UMC Utrecht:
pneumonia, anti-bacterial agents, (cost)efficacy

Additional relevant MeSH terms:
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Pneumonia
Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases
Infection
Anti-Bacterial Agents
Anti-Infective Agents