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

Not Applicable

Completed

• Conditions: Patients Under Antimicrobial Therapy
• Interventions: Other: Infectious disease specialist advice

• Registration Number: NCT01137864
• Lead Sponsor: Henri Mondor University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-01
• Study First Submitted QC: 2010-06-04
• Study First Posted: 2010-06-07
• Primary Completion: 2011-07
• Study Completion: 2011-10
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-28
• Last Update Posted: 2014-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 255

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infectious disease specialist advice	Infectious disease specialist advice	Patients receiving the intervention (infectious disease specialist advice)

Primary Outcome Measures

Name	Time	Method
Appropriateness of antimicrobial therapy	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 Outcome Measures

Name	Time	Method
Clinical impact	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	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

Trial Locations

Locations (1)

Henri Mondor University Hospital; 🇫🇷 Créteil, France