Impact of Infectious Diseases Specialists on the Appropriateness of Antimicrobial Therapy in Surgical and Medical Wards (ATBREFSURMED)
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|ClinicalTrials.gov Identifier: NCT01136200|
Recruitment Status : Completed
First Posted : June 3, 2010
Last Update Posted : July 29, 2014
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|
|Patients Receiving Antimicrobial Therapy||Other: Infectious disease specialist advice||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||264 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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 :||June 2010|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||October 2011|
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
- Appropriateness of antimicrobial therapy [ Time Frame: 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).
- Clinical impact [ Time Frame: Between days 7 and 10 after starting antimicrobial therapy ]Length of hospitalization;clinical outcome: resolution of infection; in hospital mortality
- Antibiotic exposure [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01136200
|Henri Mondor University Hospital|
|Créteil, France, 94010|
|Principal Investigator:||Philippe Lesprit, MD||Assistance Publique - Hôpitaux de Paris|