Patients Receiving Antimicrobial Therapy Clinical Trial
— ATBREFSURMEDOfficial title:
Impact of Infectious Diseases Specialists on the Appropriateness of Antimicrobial Therapy in Surgical and Medical 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 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.
| Status | Completed |
| Enrollment | 264 |
| 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 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 |
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 start, between days 3 and 5, and at the end of therapy (between days 7 and 10). | Between days 7 and 10 after starting antimicrobial therapy | No |
| Secondary | Clinical impact | Length of hospitalization;clinical outcome: resolution of infection; in hospital mortality | Between days 7 and 10 after starting antimicrobial therapy | No |
| Secondary | Antibiotic exposure | 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 |
14 days | No |