Patients Under Antimicrobial Therapy Clinical Trial
— ATBREFEMERGOfficial title:
Impact of Infectious Diseases Specialists on the Appropriateness of Antimicrobial Therapy in Emergency Wards: a Multicenter Randomized Controlled Trial.
| Verified date | July 2014 |
| Source | Henri Mondor University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | France: Ministry of Health |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 255 |
| Est. completion date | October 2011 |
| Est. primary completion date | July 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | Henri Mondor University Hospital | Créteil |
| Lead Sponsor | Collaborator |
|---|---|
| Henri Mondor University Hospital |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Appropriateness of antimicrobial therapy | Appropriateness of antimicrobial therapy will be evaluated at the end of hospitalization in emergency ward (on average, between days 1 and 3). | Between days 1 and 3 | No |
| Secondary | Clinical impact | 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). | Between days 1 and 3 | No |
| Secondary | Antibiotic exposure | 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 |
14 days | No |