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

Sponsor
Henri Mondor University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01137864
Collaborator
(none)
255
1
2
16
15.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Infectious disease specialist advice
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
255 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (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.
Study Start Date :
Jun 1, 2010
Actual Primary Completion Date :
Jul 1, 2011
Actual Study Completion Date :
Oct 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Appropriateness of antimicrobial therapy [Between days 1 and 3]

    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

  1. Clinical impact [Between days 1 and 3]

    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).

  2. Antibiotic exposure [14 days]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Philippe LESPRIT, Dr Philippe LESPRIT, Henri Mondor University Hospital
ClinicalTrials.gov Identifier:
NCT01137864
Other Study ID Numbers:
  • PREQHOS 08023b
First Posted:
Jun 7, 2010
Last Update Posted:
Jul 29, 2014
Last Verified:
Jul 1, 2014
Keywords provided by Philippe LESPRIT, Dr Philippe LESPRIT, Henri Mondor University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 29, 2014