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

July 28, 2014 updated by: Philippe LESPRIT, Henri Mondor University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

264

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Créteil, France, 94010
        • Henri Mondor University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henri Mondor University Hospital

Investigators

  • Principal Investigator: Philippe Lesprit, MD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

May 28, 2010

First Submitted That Met QC Criteria

June 2, 2010

First Posted (Estimate)

June 3, 2010

Study Record Updates

Last Update Posted (Estimate)

July 29, 2014

Last Update Submitted That Met QC Criteria

July 28, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREQHOS 08023

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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