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Completed

NCT Number: NCT01136200

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

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.

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Key information

Conditions

Patients Receiving Antimicrobial Therapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henri Mondor University Hospital

Créteil, 94010, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Infectious disease specialist advice

Other

Indication, choice, dosing and duration of antimicrobial therapy

Primary outcomes

  1. Appropriateness of antimicrobial therapy

    Time frame: Between days 7 and 10 after starting 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).

Secondary outcomes

  1. Clinical impact

    Time frame: Between days 7 and 10 after starting antimicrobial therapy

    Length of hospitalization;clinical outcome: resolution of infection; in hospital mortality

  2. Antibiotic exposure

    Time frame: 14 days

    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

Sponsors and collaborators

Lead sponsor

Henri Mondor University Hospital

Other

Registry information

Official study title

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

Acronym: ATBREFSURMED

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 3, 2010
Registry last updated
Jul 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.