PneumoniaNCT00129883
Adherence to Guidelines for Antibiotic Use in Respiratory Infections at Hospitals
A study testing Professional education, Implementation of a Critical Care Pathway and Professional audit and feedback in people with Pneumonia and Chronic Bronchitis, run by Radboud University Medical Center at 7 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Chronic Bronchitis, COPD
- What is being tested?
- Professional education, Implementation of a Critical Care Pathway and Professional audit and feedback
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,000 participants
- Where
- 7 sitesNetherlands
- Study dates
- Sep 2002to Apr 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Netherlands7 sites
Gelre Ziekenhuizen
Apeldoorn
Deventer Ziekenhuis
Deventer
Ziekenhuis Gelderse Vallei
Ede
Bernhoven Ziekenhuis
Oss
Bernhoven Ziekenhuis
Veghel
Maxima Medisch Centrum
Veldhoven
Vie Curi Medisch Centrum
Venlo
About this study
Official title: 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.
Read the 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.
- Conditions
- Pneumonia, Chronic Bronchitis, COPD
- Being tested
- Professional education, Implementation of a Critical Care Pathway, Professional audit and feedback, Process analysis and redesign
- Keywords
- quality of care, antibiotic use, intervention, lower respiratory tract infections, Community acquired Pneumonia, Acute Exacerbation of Chronic Bronchitis or COPD
- Medical subject headings
- Pneumonia, Bronchitis, Chronic, Pulmonary Disease, Chronic Obstructive, Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Professional educationBehavioural
Implementation of a Critical Care PathwayBehavioural
Professional audit and feedbackBehavioural
Process analysis and redesignBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (6)
cost
process evaluation: how well was the intervention performed
length of hospital stay
in-hospital mortality
Intensive Care Unit (ICU)-transfer
30 day re-admission rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2005 (estimated)
- Study startSep 2002
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,000 participants
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Marlies E Hulscher, MSc, PhD, Principal investigator, Centre for Quality of Care Research, Radboud University Nijmegen Medical CentreRichard P Grol, MSc, PhD, Study director, Centre for Quality of Care Research, Radboud University Nijmegen Medical CentreJos WM van der Meer, MD, PhD, Study director, Department of General Internal Medicine, Radboud University Nijmegen Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00129883
- Sponsor's protocol ID
- AGAR-2001-1
- Other IDs
- ZonMw grant no. 2300.0024
- Status last verified
- Aug 2002
- First submitted
- 11 Aug 2005
- Last updated
- 27 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Antimicrobial Resistance in Hospitals: Promoting Appropriate Use of Antibiotics in Hospital Departments of Internal and Pulmonary Medicine
- ClinicalTrials.gov ID
- NCT00129883
- Acronym / sponsor ID
- AGAR-2001-1
- Conditions
- Pneumonia, Chronic Bronchitis, COPD
- Keywords
- quality of care, antibiotic use, intervention, lower respiratory tract infections, Community acquired Pneumonia, Acute Exacerbation of Chronic Bronchitis or COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Sep 2002
- Study completion
- Apr 2005
- First posted
- 12 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Professional education | Behavioural | – |
| Implementation of a Critical Care Pathway | Behavioural | – |
| Professional audit and feedback | Behavioural | – |
| Process analysis and redesign | Behavioural | – |
Primary outcome
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)
6 secondary outcomes
cost
process evaluation: how well was the intervention performed
length of hospital stay
in-hospital mortality
Intensive Care Unit (ICU)-transfer
30 day re-admission rate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2005.
- website of Centre for Quality of Care Research, department of the Radboud University Nijmegen Medical Centre, where this study was carried outLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marlies E Hulscher, MSc, PhD principal investigator
Centre for Quality of Care Research, Radboud University Nijmegen Medical Centre
Richard P Grol, MSc, PhD study director
Centre for Quality of Care Research, Radboud University Nijmegen Medical Centre
Jos WM van der Meer, MD, PhD study director
Department of General Internal Medicine, Radboud University Nijmegen Medical Centre
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Professional education, Implementation of a Critical Care Pathway and Professional audit and feedback in people with Pneumonia and Chronic Bronchitis, run by Radboud University Medical Center at 7 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2005.