Impact of a Regional Antimicrobial Stewardship on the Length of Stay of Patients Admitted to Hospital With Pneumonia (RASPCAP)
Effectiveness of a Regional Antimicrobial Stewardship Program to Reduce the Length of Stay of Patients Admitted to Hospital With Community-acquired Pneumonia: a Pragmatic Multi-centre Clinical Study
Panoramica dello studio
Descrizione dettagliata
Antimicrobial stewardship is defined as any activity that promotes the appropriate selection, dosing, route and duration of antibiotic therapy. Antimicrobial stewardship programs usually include pharmacists and/or doctors with expertise in infection diseases management. Prospective chart review and physician feedback is a common intervention used by antimicrobial stewardship programs to improve antibiotic utilization and patient outcomes.
Pneumonia is the most common reason for antibiotic utilization in hospitals. Significant variation in antibiotic utilization for patients with pneumonia has been repeatedly demonstrated in published studies despite the existence of best-practice treatment guidelines. Treatment variation from these guidelines has been demonstrated to result in worse outcomes such as increased mortality. Antimicrobial stewardship programs can help reduce the treatment variation from guidelines.
Despite improvements in certain outcomes, antimicrobial stewardship programs have not demonstrated any impact on the length of stay of patients admitted to hospital with pneumonia. Part of this absence of evidence may be due to poor study design and failure to recruit sufficient patients. This study will include the implementation of an antimicrobial stewardship program across many hospitals and the study design and analysis will account for the design problems of the previous studies.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
Ontario
-
Barrie, Ontario, Canada, L4M6M2
- Royal Victoria Regional Health Centre
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Community-acquired pneumonia
- Immunocompetent
- Age > 18 years
Exclusion Criteria:
- Admitted to an intensive care unit or high intensity unit
- Requiring invasive or non-invasive ventilation
- Life expectancy less than 3 months
- Hospitalization within the previous 3 months for at least 48 consecutive hours
- Immunocompromised defined as defined as having leukemia, lymphoma, HIV with CD4 count <=200, splenectomy or on cytotoxic chemotherapy
- Neutropenic [defined as a PMN count<=0.5x109 cells/L] from any cause
- Receiving immunosuppressants [defined as >=40 mg prednisone daily (or steroid equivalent) for >=2 weeks preceding hospitalization OR any other immunosuppressant used for systemic illness OR to prevent transplant rejection
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
intervention
exposure to antimicrobial stewardship intervention
|
A member of the antimicrobial stewardship program will prospectively review the patient's medical record and make recommendations to the most responsible physician in the care of that patient
Altri nomi:
|
|
control
usual care with no exposure to antimicrobial stewardship
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Length of hospital stay
Lasso di tempo: Days from time of admission to time of discharge from hospital to a maximum of 14 days from the date of admission (or time to censoring at 14 days from the date of admissionor competing event depending on which comes first)
|
Time (measured in days) from date of admission to one of the following potential outcomes, discharge alive, censoring at 14 days post admission, death, admission to an intensive care unit, or transfer to another hospital
|
Days from time of admission to time of discharge from hospital to a maximum of 14 days from the date of admission (or time to censoring at 14 days from the date of admissionor competing event depending on which comes first)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Days of antibiotic therapy
Lasso di tempo: Days of antibiotic therapy for the treatment of pneumonia measured from the first day of antibiotic administered to the final day of antibiotic administered upto a maximum of 80 days
|
Total days of antibiotics administered for the treatment of community-acquired pneumonia
|
Days of antibiotic therapy for the treatment of pneumonia measured from the first day of antibiotic administered to the final day of antibiotic administered upto a maximum of 80 days
|
|
Mortality rate
Lasso di tempo: 30 day post-discharge from hospital
|
Deaths that occur post-discharge from hospital up to 30 days post-discharge
|
30 day post-discharge from hospital
|
|
Readmission to hospital
Lasso di tempo: 30 day post-discharge from hospital
|
Readmissions to hospital that occur post-discharge from hospital up to 30 days post-discharge
|
30 day post-discharge from hospital
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Giulio DiDiodato, MD, Physician
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- RASP2013
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .