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

Not Applicable

Completed

• Conditions: Patients Receiving Antimicrobial Therapy

• 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

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