- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00129883
Adherence to Guidelines for Antibiotic Use in Respiratory Infections at Hospitals
Prevention of Antimicrobial Resistance in Hospitals: Promoting Appropriate Use of Antibiotics in Hospital Departments of Internal and Pulmonary Medicine
Study Overview
Status
Conditions
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
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Apeldoorn, Netherlands
- Gelre Ziekenhuizen
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Deventer, Netherlands
- Deventer Ziekenhuis
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Ede, Netherlands
- Ziekenhuis Gelderse Vallei
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Oss, Netherlands
- Bernhoven Ziekenhuis
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Veghel, Netherlands
- Bernhoven Ziekenhuis
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Veldhoven, Netherlands
- Maxima Medisch Centrum
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Venlo, Netherlands
- Vie Curi Medisch Centrum
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
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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)
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Secondary Outcome Measures
Outcome Measure |
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length of hospital stay
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cost
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process evaluation: how well was the intervention performed
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in-hospital mortality
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Intensive Care Unit (ICU)-transfer
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30 day re-admission rate
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Collaborators and Investigators
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
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AGAR-2001-1
- ZonMw grant no. 2300.0024
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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