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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Henri Mondor University Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Henri Mondor University Hospital
ClinicalTrials.gov Identifier:
NCT01136200
First received: May 28, 2010
Last updated: June 2, 2010
Last verified: May 2010
History of Changes
  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 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 Intervention
Patients Receiving 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 Surgical and Medical Wards: a Multicenter Randomized Controlled Trial.

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Further study details as provided by Henri Mondor University Hospital:

Primary Outcome Measures:
  • Appropriateness of antimicrobial therapy [ Time Frame: Between days 7 and 10 after starting antimicrobial therapy ] [ Designated as safety issue: No ]
    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:
  • Clinical impact [ Time Frame: Between days 7 and 10 after starting antimicrobial therapy ] [ Designated as safety issue: No ]
    Length of hospitalization;clinical outcome: resolution of infection; in hospital mortality

  • Antibiotic exposure [ Time Frame: 14 days ] [ Designated as safety issue: No ]

    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



Estimated Enrollment: 248
Study Start Date: June 2010
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: May 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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01136200

Contacts
Contact: Philippe Lesprit, MD 33149814691 philippe.lesprit@hmn.aphp.fr
Contact: Caroline Quintin 33133140257966 caroline.quintin@bch.aphp.fr

Locations
France
Henri Mondor University Hospital Not yet recruiting
Créteil, France, 94010
Contact: Philippe Lesprit, MD     33149814691     philippe.lesprit@hmn.aphp.fr    
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: Dr P. Lesprit, Hôpital Henri Mondor, Assistance Publique Hôpitaux de Paris, Unité de Contrôle Epidémiologie Prévention de l'Infection
ClinicalTrials.gov Identifier: NCT01136200     History of Changes
Other Study ID Numbers: PREQHOS 08023
Study First Received: May 28, 2010
Last Updated: June 2, 2010
Health Authority: France: Ministry of Health

Keywords provided by Henri Mondor University Hospital:
Surgical and medical wards
Adults
Antimicrobial therapy

Additional relevant MeSH terms:
Communicable Diseases
Infection
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013