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

Not Applicable

Completed

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

• Registration Number: NCT01136200
• 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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-28
• Study Start: 2010-06
• Study First Submitted QC: 2010-06-02
• Study First Posted: 2010-06-03
• 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: 264

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

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 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 Outcome Measures

Name	Time	Method
Antibiotic exposure	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
Clinical impact	Between days 7 and 10 after starting antimicrobial therapy	Length of hospitalization;clinical outcome: resolution of infection; in hospital mortality

Trial Locations

Locations (1)

Henri Mondor University Hospital; 🇫🇷 Créteil, France