Adherence to Guidelines for Antibiotic Use in Respiratory Infections at Hospitals

September 26, 2005 updated by: Radboud University Medical Center

Prevention of Antimicrobial Resistance in Hospitals: Promoting Appropriate Use of Antibiotics in Hospital Departments of Internal and Pulmonary Medicine

The purpose of this study is to test a strategy to improve the quality of antibiotic use in lower respiratory tract infections (LRTIs) at hospitals. Therefore, a multifaceted intervention strategy is compared to a control strategy and the effectiveness and feasibility of the intervention is assessed.

Study Overview

Detailed Description

Improving processes of care in patients with hospital LRTI has been related to better patient outcome. Inappropriate use of antibiotics has contributed to the emergence and spread of drug-resistant micro organisms and increased treatment costs. International guidelines provide recommendations for the initial evaluation and management of LRTI, including advice on judicious antibiotic therapy. Nonetheless, studies have demonstrated a wide variability in adherence to these guidelines.

To implement key recommendations in clinical practice, various strategies have been used, with mixed results. Perhaps the most important aspect of choosing a potentially effective intervention is that the choice of intervention should be based upon assessment of potential barriers in the target group. Many intervention studies are flawed by failing to control for secular trends.

The investigators performed a cluster randomised controlled trial, to study the effect of a multifaceted intervention strategy on the quality of antibiotic use for LRTI. Their intervention was tailored to the areas most in need for improvement and took perceived barriers in the target group into consideration at the individual hospital level.

Study Type

Interventional

Enrollment

2000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Apeldoorn, Netherlands
        • Gelre Ziekenhuizen
      • Deventer, Netherlands
        • Deventer Ziekenhuis
      • Ede, Netherlands
        • Ziekenhuis Gelderse Vallei
      • Oss, Netherlands
        • Bernhoven Ziekenhuis
      • Veghel, Netherlands
        • Bernhoven Ziekenhuis
      • Veldhoven, Netherlands
        • Maxima Medisch Centrum
      • Venlo, Netherlands
        • Vie Curi Medisch Centrum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients admitted to a respiratory care or internal medicine ward with community-acquired pneumonia or acute exacerbation of chronic bronchitis or chronic obstructive pulmonary disease (COPD)

Exclusion Criteria:

  • Recent (< 30 days) admission for LRTI
  • Patients with underlying immunodeficiency (HIV infection, neutropenia, treatment with immunomodulating drugs, active hematological malignancies, anatomical or functional asplenia and hypogammaglobulinemia)
  • Patients already on treatment with antibiotics for another culture proven infection at the time of admission
  • Patients from nursing homes
  • Patients who had been transferred to another hospital or ICU and patients who had died within 24 hours of admission
  • Patients with very poor prognosis (life expectancy < 2 weeks on admission).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Educational/Counseling/Training
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
adherence to key quality indicators for antibiotic use in lower respiratory tract infections (indicators were developed from current [inter]national guideline recommendations and a systematic review of the literature)

Secondary Outcome Measures

Outcome Measure
length of hospital stay
cost
process evaluation: how well was the intervention performed
in-hospital mortality
Intensive Care Unit (ICU)-transfer
30 day re-admission rate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Marlies E Hulscher, MSc, PhD, Centre for Quality of Care Research, Radboud University Nijmegen Medical Centre
  • Study Director: Richard P Grol, MSc, PhD, Centre for Quality of Care Research, Radboud University Nijmegen Medical Centre
  • Study Director: Jos WM van der Meer, MD, PhD, Department of General Internal Medicine, Radboud University Nijmegen Medical Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Study Completion

April 1, 2005

Study Registration Dates

First Submitted

August 11, 2005

First Submitted That Met QC Criteria

August 11, 2005

First Posted (Estimate)

August 12, 2005

Study Record Updates

Last Update Posted (Estimate)

September 27, 2005

Last Update Submitted That Met QC Criteria

September 26, 2005

Last Verified

August 1, 2002

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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