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Completed

NCT Number: NCT00129883

Adherence to Guidelines for Antibiotic Use in Respiratory Infections at Hospitals

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gelre Ziekenhuizen, Apeldoorn, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Professional education

Behavioral

Implementation of a Critical Care Pathway

Behavioral

Professional audit and feedback

Behavioral

Process analysis and redesign

Behavioral

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2005
First posted
Aug 12, 2005
Registry last updated
Sep 27, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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