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

Primary Purpose

Patients Under Antimicrobial Therapy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Infectious disease specialist advice
Sponsored by
Henri Mondor University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patients Under Antimicrobial Therapy focused on measuring Emergency wards, Hospitalization, Adults, Antimicrobial therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Henri Mondor University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Infectious disease specialist advice

Control

Arm Description

Patients receiving the intervention (infectious disease specialist advice)

Patients not receiving infectious disease specialist advice

Outcomes

Primary Outcome Measures

Appropriateness of antimicrobial therapy
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

Clinical impact
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
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

Full Information

First Posted
June 1, 2010
Last Updated
July 28, 2014
Sponsor
Henri Mondor University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01137864
Brief Title
Impact of Infectious Diseases Specialists on the Appropriateness of Antimicrobial Therapy in Emergency Wards
Acronym
ATBREFEMERG
Official Title
Impact of Infectious Diseases Specialists on the Appropriateness of Antimicrobial Therapy in Emergency Wards: a Multicenter Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henri Mondor University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients Under Antimicrobial Therapy
Keywords
Emergency wards, Hospitalization, Adults, Antimicrobial therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
255 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Infectious disease specialist advice
Arm Type
Experimental
Arm Description
Patients receiving the intervention (infectious disease specialist advice)
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients not receiving infectious disease specialist advice
Intervention Type
Other
Intervention Name(s)
Infectious disease specialist advice
Intervention Description
Indication, choice, dosing and duration of antimicrobial therapy
Primary Outcome Measure Information:
Title
Appropriateness of antimicrobial therapy
Description
Appropriateness of antimicrobial therapy will be evaluated at the end of hospitalization in emergency ward (on average, between days 1 and 3).
Time Frame
Between days 1 and 3
Secondary Outcome Measure Information:
Title
Clinical impact
Description
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).
Time Frame
Between days 1 and 3
Title
Antibiotic exposure
Description
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
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Lesprit, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henri Mondor University Hospital
City
Créteil
ZIP/Postal Code
94010
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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