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

Sponsor
Henri Mondor University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01136200
Collaborator
(none)
264
1
2
16
16.5

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 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.

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

Study Design

Study Type:
Interventional
Actual Enrollment :
264 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 Surgical and Medical 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 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 Outcome Measures

  1. Clinical impact [Between days 7 and 10 after starting antimicrobial therapy]

    Length of hospitalization;clinical outcome: resolution of infection; in hospital mortality

  2. Antibiotic exposure [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

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 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

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:
NCT01136200
Other Study ID Numbers:
  • PREQHOS 08023
First Posted:
Jun 3, 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