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

NCT01660204 | Completed

• 2 other identifiers: 10-14880-82310-97-12044
• Study Type: interventional
• Target: 2,283
• Locations: 1 country
• Sites: 7

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.

Conditions

Community-acquired Pneumonia

Keywords

pneumonia, anti-bacterial agents, (cost)efficacy

Outcome Measures

Primary Outcomes (1)

• Day 90 Mortality

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

  90 days from admission

Secondary Outcomes (5)

• Length of intravenous antibiotic treatment

  Participants will be followed for the duration of hospital stay, an expected average of 1 week

• Length of hospital stay

  Participants will be followed for the duration of hospital stay, an expected average of 1 week

• Tolerability

  Participants will be followed for the duration of hospital stay, an expected average of 1 week

• Complications

  Participants will be followed for the duration of hospital stay, an expected average of 1 week

• Health care costs and non-health care costs

  28 days from admission

Study Arms (3)

Betalactam monotherapy

ACTIVE COMPARATOR

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

Other: Preferred empirical treatment

Betalactam combination with macrolide

ACTIVE COMPARATOR

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

Quinolone monotherapy

ACTIVE COMPARATOR

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

Other: Preferred empirical treatment

Interventions

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.

Betalactam combination with macrolide; Betalactam monotherapy; Quinolone monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admission is defined as hospital stay for more than 24 hours.

You may not qualify if:

• Patients who are readmitted with CAP within 2 weeks after a previous episode are not eligible.
• Patients with cystic fibrosis are not eligible.

Sponsors & Collaborators

• UMC Utrecht: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (7)

Medical Center Alkmaar

Alkmaar, Netherlands

Location

AMC Amsterdam

Amsterdam, Netherlands

Location

Amphia Hospital Breda

Breda, Netherlands

Location

Kennemer Gasthuis

Haarlem, Netherlands

Location

Spaarne Hospital

Hoofddorp, Netherlands

Location

Diakonessenhuis Utrecht

Utrecht, Netherlands

Location

UMC Utrecht

Utrecht, Netherlands

Location

Related Publications (4)

• 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.

  PMID: 30612559 DERIVED

• 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.

  PMID: 28068956 DERIVED

• 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.

  PMID: 25830421 DERIVED

• 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.

  PMID: 24846935 DERIVED

MeSH Terms

Conditions

Community-Acquired Pneumonia; Pneumonia

Condition Hierarchy (Ancestors)

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

Study Officials

• Marc J. Bonten, MD PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 2, 2012
• First Posted: August 8, 2012
• Study Start: February 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: January 1, 2014
• Last Updated: April 23, 2014

Record last verified: 2014-04

Locations

NL (7)