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Completed

NCT Number: NCT01660204

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

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.

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Key information

Conditions

Community-Acquired Pneumonia Community-Acquired Infections Infections Lung Diseases Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical Center Alkmaar, Alkmaar, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Preferred empirical treatment

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

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

Acronym: CAP-START

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Aug 8, 2012
Registry last updated
Apr 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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