Clinical trial NCT01660204: Community-Acquired Pneumonia - Study on the Initial Treatment With Antibiotics of Lower Respiratory Tract Infections
Official title: Antibiotic Treatment of Community-acquired Pneumonia: a Prospective Comparison of Dutch Guideline Advices.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Community-acquired Pneumonia
Keywords: pneumonia, anti-bacterial agents, (cost)efficacy
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2012-08-08
Enrollment: 2283
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Day 90 Mortality
timeFrame: 90 days from admission
Secondary outcomes:
measure: Length of intravenous antibiotic treatment
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
measure: Length of hospital stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
measure: Tolerability
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
measure: Complications
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
measure: Health care costs and non-health care costs
timeFrame: 28 days from admission
Other outcomes:
Locations:
city: Alkmaar
country: Netherlands
facility: Medical Center Alkmaar
city: Amsterdam
country: Netherlands
facility: AMC Amsterdam
city: Breda
country: Netherlands
facility: Amphia Hospital Breda
city: Haarlem
country: Netherlands
facility: Kennemer Gasthuis
city: Hoofddorp
country: Netherlands
facility: Spaarne Hospital
city: Utrecht
country: Netherlands
facility: Diakonessenhuis Utrecht
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
affiliation: UMC Utrecht
name: Marc J. Bonten, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.