NCT00129883

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2002

Typical duration for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 12, 2005

Completed
Last Updated

September 27, 2005

Status Verified

August 1, 2002

First QC Date

August 11, 2005

Last Update Submit

September 26, 2005

Conditions

Keywords

quality of careantibiotic useinterventionlower respiratory tract infectionsCommunity acquired PneumoniaAcute Exacerbation of Chronic Bronchitis or COPD

Outcome Measures

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 (6)

  • cost

  • process evaluation: how well was the intervention performed

  • length of hospital stay

  • in-hospital mortality

  • Intensive Care Unit (ICU)-transfer

  • +1 more secondary outcomes

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Gelre Ziekenhuizen

Apeldoorn, Netherlands

Location

Deventer Ziekenhuis

Deventer, Netherlands

Location

Ziekenhuis Gelderse Vallei

Ede, Netherlands

Location

Bernhoven Ziekenhuis

Oss, Netherlands

Location

Bernhoven Ziekenhuis

Veghel, Netherlands

Location

Maxima Medisch Centrum

Veldhoven, Netherlands

Location

Vie Curi Medisch Centrum

Venlo, Netherlands

Location

Related Links

MeSH Terms

Conditions

PneumoniaBronchitis, ChronicPulmonary Disease, Chronic ObstructiveCommunity-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesBronchitisBronchial DiseasesLung Diseases, ObstructiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCommunity-Acquired Infections

Study Officials

  • Marlies E Hulscher, MSc, PhD

    Centre for Quality of Care Research, Radboud University Nijmegen Medical Centre

    PRINCIPAL INVESTIGATOR
  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
ECT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 11, 2005

First Posted

August 12, 2005

Study Start

September 1, 2002

Study Completion

April 1, 2005

Last Updated

September 27, 2005

Record last verified: 2002-08

Locations