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Impact of Infectious Diseases Specialists on the Appropriateness of Antimicrobial Therapy in Surgical and Medical Wards

Impact of Infectious Diseases Specialists on the Appropriateness of Antimicrobial Therapy in Surgical and Medical Wards: a Multicenter Randomized Controlled Trial.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01136200
Acronym
ATBREFSURMED
Enrollment
264
Registered
2010-06-03
Start date
2010-06-30
Completion date
2011-10-31
Last updated
2014-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients Receiving Antimicrobial Therapy

Keywords

Surgical and medical wards, Adults, Antimicrobial therapy

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.

Interventions

Indication, choice, dosing and duration of antimicrobial therapy

Sponsors

Henri Mondor University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Appropriateness of antimicrobial therapyBetween days 7 and 10 after starting antimicrobial therapyAppropriateness 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).

Secondary

MeasureTime frameDescription
Clinical impactBetween days 7 and 10 after starting antimicrobial therapyLength of hospitalization;clinical outcome: resolution of infection; in hospital mortality
Antibiotic exposure14 daysAntibiotic 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026