Impact of Infectious Diseases Specialists on the Appropriateness of Antimicrobial Therapy in Emergency Wards

Overview

CONTEXT: Antibiotics are frequently used in hospital but the appropriateness of prescriptions ranged between 25-50%. The intervention of infectious disease specialists (IDS) could improve the appropriateness of prescriptions and reduce their use. The impact of IDS has not been yet fully estimated using a randomized trial to compare the quality of care of patients who will benefit of the intervention. OBJECTIVES: To show using a randomized trial that patients hospitalized in emergency wards with IDS advice will receive more appropriate antimicrobial therapy but less exposure to antibiotics, as compared to patients who will not receive IDS advice. METHODS: Prospective randomized trial comparing antibiotic exposure and appropriateness of prescriptions in two groups of patients admitted in emergency wards: Control group: antibiotic prescriptions will be initiated and managed by the attending physicians Intervention group: antibiotic prescriptions will be systematically evaluated by the IDS and changed if judged necessary by the attending physicians, following IDS' advice. STUDY PROCESS: The study will took place in the emergency wards of 4 university hospitals. For each ward, the period of the study will be 2 x 4 weeks.Total duration of the study: 12 months.

Full Title of Study: “Impact of Infectious Diseases Specialists on the Appropriateness of Antimicrobial Therapy in Emergency Wards: a Multicenter Randomized Controlled Trial.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: July 2011

Interventions

  • Other: Infectious disease specialist advice
    • Indication, choice, dosing and duration of antimicrobial therapy

Arms, Groups and Cohorts

  • Experimental: Infectious disease specialist advice
    • Patients receiving the intervention (infectious disease specialist advice)
  • No Intervention: Control
    • Patients not receiving infectious disease specialist advice

Clinical Trial Outcome Measures

Primary Measures

  • Appropriateness of antimicrobial therapy
    • Time Frame: Between days 1 and 3
    • Appropriateness of antimicrobial therapy will be evaluated at the end of hospitalization in emergency ward (on average, between days 1 and 3).

Secondary Measures

  • Clinical impact
    • Time Frame: Between days 1 and 3
    • Length of hospitalization; clinical outcome: resolution of infection; in hospital mortality. These end points will be evaluated at the end of hospitalization in emergency ward (on average, between days 1 and 3).
  • Antibiotic exposure
    • Time Frame: 14 days
    • Antibiotic exposure will be evaluated at the time of discharge from emergency ward (on average, between days 1 and 3) using the following parameters: number of days of therapy/numbers of days of hospitalization; defined daily doses of antibiotic/number of days of hospitalization

Participating in This Clinical Trial

Inclusion Criteria

  • Adults Hospitalized in emergency wards Receiving antimicrobial therapy for active infection or prolonged surgical prophylaxis Therapy prescribed by the attending ward physician Exclusion Criteria:

  • Patients receiving antimicrobial therapy not prescribed by the attending ward physician

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Henri Mondor University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Philippe LESPRIT, Dr Philippe LESPRIT – Henri Mondor University Hospital
  • Overall Official(s)
    • Philippe Lesprit, MD, Principal Investigator, Assistance Publique – Hôpitaux de Paris

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