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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