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Clinical Trials/NCT01136200
NCT01136200
Completed
Not Applicable

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

Henri Mondor University Hospital1 site in 1 country264 target enrollmentJune 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patients Receiving Antimicrobial Therapy
Sponsor
Henri Mondor University Hospital
Enrollment
264
Locations
1
Primary Endpoint
Appropriateness of antimicrobial therapy
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2010
End Date
October 2011
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Henri Mondor University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Philippe LESPRIT

Dr Philippe LESPRIT

Henri Mondor University Hospital

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

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 Outcomes

  • Antibiotic exposure(14 days)
  • Clinical impact(Between days 7 and 10 after starting antimicrobial therapy)

Study Sites (1)

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