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Adherence to Guidelines for Antibiotic Use in Respiratory Infections at Hospitals

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00129883
Recruitment Status : Completed
First Posted : August 12, 2005
Last Update Posted : September 27, 2005
Information provided by:
Radboud University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pneumonia Chronic Bronchitis COPD Behavioral: Professional education Behavioral: Implementation of a Critical Care Pathway Behavioral: Professional audit and feedback Behavioral: Process analysis and redesign Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Educational/Counseling/Training
Official Title: Prevention of Antimicrobial Resistance in Hospitals: Promoting Appropriate Use of Antibiotics in Hospital Departments of Internal and Pulmonary Medicine
Study Start Date : September 2002
Study Completion Date : April 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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 :
  1. cost
  2. process evaluation: how well was the intervention performed
  3. length of hospital stay
  4. in-hospital mortality
  5. Intensive Care Unit (ICU)-transfer
  6. 30 day re-admission rate

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00129883

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Gelre Ziekenhuizen
Apeldoorn, Netherlands
Deventer Ziekenhuis
Deventer, Netherlands
Ziekenhuis Gelderse Vallei
Ede, Netherlands
Bernhoven Ziekenhuis
Oss, Netherlands
Bernhoven Ziekenhuis
Veghel, Netherlands
Maxima Medisch Centrum
Veldhoven, Netherlands
Vie Curi Medisch Centrum
Venlo, Netherlands
Sponsors and Collaborators
Radboud University
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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

Additional Information:
Layout table for additonal information Identifier: NCT00129883    
Other Study ID Numbers: AGAR-2001-1
ZonMw grant no. 2300.0024
First Posted: August 12, 2005    Key Record Dates
Last Update Posted: September 27, 2005
Last Verified: August 2002
Keywords provided by Radboud University:
quality of care
antibiotic use
lower respiratory tract infections
Community acquired Pneumonia
Acute Exacerbation of Chronic Bronchitis or COPD
Additional relevant MeSH terms:
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Bronchitis, Chronic
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bronchial Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents