Clinical trial NCT01136200: Impact of Infectious Diseases Specialists on the Appropriateness of Antimicrobial Therapy in Surgical and Medical Wards
Official title: Impact of Infectious Diseases Specialists on the Appropriateness of Antimicrobial Therapy in Surgical and Medical Wards: a Multicenter Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients Receiving Antimicrobial Therapy
Keywords: Surgical and medical wards
Adults
Antimicrobial therapy
Lead sponsor: Henri Mondor University Hospital
Sponsor class: OTHER
First posted: 2010-06-03
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Appropriateness of antimicrobial therapy
timeFrame: Between days 7 and 10 after starting antimicrobial therapy
Secondary outcomes:
measure: Clinical impact
timeFrame: Between days 7 and 10 after starting antimicrobial therapy
measure: Antibiotic exposure
timeFrame: 14 days
Other outcomes:
Locations:
city: Créteil
country: France
facility: Henri Mondor University Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Philippe Lesprit, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lesprit P, de Pontfarcy A, Esposito-Farese M, Ferrand H, Mainardi JL, Lafaurie M, Parize P, Rioux C, Tubach F, Lucet JC. Postprescription review improves in-hospital antibiotic use: a multicenter randomized controlled trial. Clin Microbiol Infect. 2015 Feb;21(2):180.e1-7. doi: 10.1016/j.cmi.2014.08.015. Epub 2014 Oct 14.