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Impact of a Regional Antimicrobial Stewardship on the Length of Stay of Patients Admitted to Hospital With Pneumonia (RASPCAP)

24 januari 2020 uppdaterad av: Giulio DiDiodato, Royal Victoria Hospital, Canada

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

This study evaluates the effectiveness of an antimicrobial stewardship program to reduce the length of stay of patients admitted to hospital with a diagnosis of pneumonia. The antimicrobial stewardship program will be implemented in several hospitals in Ontario, Canada. The program will identify patients with pneumonia, review their charts and make recommendations to their attending physicians about antibiotic management.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

1400

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Kanada
    • Ontario
      • Barrie, Ontario, Kanada, L4M6M2
        • Royal Victoria Regional Health Centre

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Adult patients over the age of 18 years admitted to a hospital ward with a diagnosis of community-acquired pneumonia as determined by the most responsible physician

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
intervention
exposure to antimicrobial stewardship intervention
Övrig: antimicrobial stewardship
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
Andra namn:
  • prospective audit and feedback
control
usual care with no exposure to antimicrobial stewardship

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Length of hospital stay
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Days of antibiotic therapy
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Royal Victoria Hospital, Canada

Utredare

  • Huvudutredare: Giulio DiDiodato, MD, Physician

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 april 2015

Primärt slutförande (Faktisk)

1 mars 2017

Avslutad studie (Faktisk)

1 april 2017

Studieregistreringsdatum

Först inskickad

22 oktober 2014

Först inskickad som uppfyllde QC-kriterierna

23 oktober 2014

Första postat (Uppskatta)

27 oktober 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

27 januari 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

24 januari 2020

Senast verifierad

1 januari 2020

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • RASP2013

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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