Impact of Infectious Diseases Specialists on the Appropriateness of Antimicrobial Therapy in Emergency Wards (ATBREFEMERG)
Recruitment status was Not yet recruiting
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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. |
- 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).
- 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
| 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 |
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| Contact: Philippe Lesprit, MD | 33149814691 | philippe.lesprit@hmn.aphp.fr |
| Contact: Caroline Quintin | 33133140257966 | caroline.quintin@bcb.aphp.fr |
| France | |
| Henri Mondor University Hospital | Not yet recruiting |
| Créteil, France, 94010 | |
| Contact: Philippe Lesprit, MD 33149814691 philippe.lesprit@hmn.aphp.fr | |
| Principal Investigator: Philippe Lesprit, MD | |
| 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: | NCT01137864 History of Changes |
| Other Study ID Numbers: | PREQHOS 08023b |
| Study First Received: | June 1, 2010 |
| Last Updated: | June 4, 2010 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Henri Mondor University Hospital:
|
Emergency wards Hospitalization Adults Antimicrobial therapy |
Additional relevant MeSH terms:
|
Communicable Diseases Infection Emergencies Disease Attributes |
Pathologic Processes Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013