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

Community-acquired Pneumonia Clinical Trial

— CAP-START  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01660204
• Other study ID #: 10-148
• Secondary ID: 80-82310-97-1204
• Status: Completed
• Phase: N/A
• First received: May 2, 2012
• Last updated: April 22, 2014
• Start date: February 2011
• Est. completion date: January 2014

Study information

• Verified date: April 2014
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2283
• Est. completion date: January 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Community-acquired Pneumonia
• Pneumonia
• Respiratory Tract Infections

Intervention

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.

Locations

Country	Name	City	State
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

Sponsors (2)

Lead Sponsor	Collaborator
UMC Utrecht	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Day 90 Mortality	We will assess all-cause mortality on day 90 from admission from the municipal personal records database	90 days from admission	No
Secondary	Length of intravenous antibiotic treatment		Participants will be followed for the duration of hospital stay, an expected average of 1 week	No
Secondary	Length of hospital stay		Participants will be followed for the duration of hospital stay, an expected average of 1 week	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

•   Dutch website of study progress