Impact of Infectious Diseases Specialists on the Appropriateness of Antimicrobial Therapy in Surgical and Medical 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 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: – 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 4 university hospitals. Two medical or surgical wards will participate by hospital. 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 Surgical and Medical 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 7 and 10 after starting antimicrobial therapy
    • Appropriateness of antimicrobial therapy will be evaluated at the start, between days 3 and 5, and at the end of therapy (between days 7 and 10).

Secondary Measures

  • Clinical impact
    • Time Frame: Between days 7 and 10 after starting antimicrobial therapy
    • Length of hospitalization;clinical outcome: resolution of infection; in hospital mortality
  • Antibiotic exposure
    • Time Frame: 14 days
    • Antibiotic exposure will be evaluated 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 surgical or medical 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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