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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Philippe LESPRIT, Henri Mondor University Hospital
ClinicalTrials.gov Identifier:
NCT01137864
First received: June 1, 2010
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Patients Under Antimicrobial Therapy
Other: Infectious disease specialist advice

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Infectious Diseases Specialists on the Appropriateness of Antimicrobial Therapy in Emergency Wards: a Multicenter Randomized Controlled Trial.

Further study details as provided by Henri Mondor University Hospital:

Primary Outcome Measures:
  • Appropriateness of antimicrobial therapy [ Time Frame: Between days 1 and 3 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Between days 1 and 3 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 14 days ] [ Designated as safety issue: No ]

    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



Enrollment: 255
Study Start Date: June 2010
Study Completion Date: October 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01137864

Locations
France
Henri Mondor University Hospital
Créteil, France, 94010
Sponsors and Collaborators
Henri Mondor University Hospital
Investigators
Principal Investigator: Philippe Lesprit, MD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Philippe LESPRIT, Dr Philippe LESPRIT, Henri Mondor University Hospital
ClinicalTrials.gov Identifier: NCT01137864     History of Changes
Other Study ID Numbers: PREQHOS 08023b
Study First Received: June 1, 2010
Last Updated: July 28, 2014
Health Authority: France: Ministry of Health

Keywords provided by Henri Mondor University Hospital:
Emergency wards
Hospitalization
Adults
Antimicrobial therapy

Additional relevant MeSH terms:
Emergencies
Communicable Diseases
Infection
Disease Attributes
Pathologic Processes
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014