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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00129883 |
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Date of registration:
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11/08/2005 |
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Primary sponsor: |
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Public title:
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Adherence to Guidelines for Antibiotic Use in Respiratory Infections at Hospitals
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Scientific title:
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Prevention of Antimicrobial Resistance in Hospitals: Promoting Appropriate Use of Antibiotics in Hospital Departments of Internal and Pulmonary Medicine |
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Date of first enrolment:
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September 2002 |
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Target sample size:
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2000 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00129883 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Marlies E Hulscher, MSc, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre for Quality of Care Research, Radboud University Nijmegen Medical Centre |
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Name:
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Richard P Grol, MSc, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre for Quality of Care Research, Radboud University Nijmegen Medical Centre |
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Name:
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Jos WM van der Meer, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of General Internal Medicine, Radboud University Nijmegen Medical Centre |
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Key inclusion & exclusion criteria
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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).
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chronic Bronchitis
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COPD
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Pneumonia
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Intervention(s)
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Behavioral: Implementation of a Critical Care Pathway
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Behavioral: Process analysis and redesign
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Behavioral: Professional audit and feedback
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Behavioral: Professional education
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Primary Outcome(s)
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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(s)
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30 day re-admission rate
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cost
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in-hospital mortality
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Intensive Care Unit (ICU)-transfer
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length of hospital stay
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process evaluation: how well was the intervention performed
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Secondary ID(s)
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AGAR-2001-1
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ZonMw grant no. 2300.0024
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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