Impact of Infectious Diseases Specialists on the Appropriateness of Antimicrobial Therapy in Surgical and Medical Wards

Study Overview
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Brief Summary
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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.

Official Title
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Impact of Infectious Diseases Specialists on the Appropriateness of Antimicrobial Therapy in Surgical and Medical Wards: a Multicenter Randomized Controlled Trial.

Conditions
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Patients Receiving Antimicrobial Therapy

Intervention / Treatment
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* Other: Infectious disease specialist advice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Infectious disease specialist advice<br>Patients receiving the intervention (infectious disease specialist advice) | Other: Infectious disease specialist advice<br>* Indication, choice, dosing and duration of antimicrobial therapy<br>|
| No Intervention: Control<br>Patients not receiving infectious disease specialist advice | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appropriateness of 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). | Between days 7 and 10 after starting antimicrobial therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical impact | Length of hospitalization;clinical outcome: resolution of infection; in hospital mortality | Between days 7 and 10 after starting antimicrobial therapy | 
| Antibiotic exposure | 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 | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgical and medical wards, Adults, Antimicrobial therapy