DetermInants of Antimicrobial Use aNd De-escalAtion in Critical Care

NCT03664245 | Unknown

• 1 other identifier: 2017-20
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

Appropriate initial antibiotic therapy is crucial in the treatment of severe infections in patients with intensive care. Adequate spectrum and appropriate doses are the keys to achieving the therapeutic goal. Despite broad consensus on the spectrum and timing of antimicrobial therapy, antibiotic use varies according to various parameters including choice, dose, method of administration, duration of antibiotic therapy and de-escalation. an empirical attitude. Therapeutic de-escalation is considered essential for the use of antibiotics and is now clearly established by different consensus. However, routine de-escalation has recently been questioned in a randomized, controlled study that did not demonstrate non-inferiority of de-escalation with an increase in the number of days of antibiotic therapy associated with an increased number of days. superinfection. The components of the de-escalation described in the literature, are based on the reduction of the number of antibiotics, the strict observance of the spectrum of the antibiotic, the reduction of use of the antibiotic, the stopping of any inappropriate antibiotic treatment ( lack of in vitro activity). De-escalation can be considered in different ways; there are significant variations between hospitals, countries, teams. A large European multicenter cohort is needed. The main objective of this study is to describe empiric antibiotic therapy in intensive care and the modalities of de-escalation.

Conditions

Emergencies

Outcome Measures

Primary Outcomes (1)

• Antibiotic used

  analyse the list of antibiotics used during 28 days

  28 days

Study Arms (1)

experimental group

Critically ill patients receiving empirical antibiotic therapy for suspected or confirmed infections at the Intensive Care Unit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients receiving empirical antibiotic therapy for suspected or confirmed infections at the Intensive Care Unit

You may qualify if:

• Age 18 years or older.
• Patient is admitted to an ICU and has an anticipated need of ICU support of at least 48 hours.
• Patient has a suspected or confirmed bacterial infection (community-, healthcare-, hospital- or ICU-acquired).
• Empirical antibiotic therapy is started for this infection at any time in the ICU or no more than 24 hours prior to ICU admission. If the initial antibiotic therapy is considered inadequate and another empirical scheme is chosen at ICU admission, this will be the empirical antibiotic of the study.
• Causative pathogen and susceptibility are unidentified at time of initiation of the antibiotic therapy.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Des Hopitaux de Marseille

Marseille, PACA, 13354, France

RECRUITING

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• EMILIE GARRIDO PRADALIE, MD

  APHM

  STUDY DIRECTOR

Central Study Contacts

MARC LEONE

CONTACT

+33 491368655; Marc.LEONE@ap-hm.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2018
• First Posted: September 10, 2018
• Study Start: December 11, 2017
• Primary Completion: December 31, 2017
• Study Completion: November 1, 2018
• Last Updated: September 10, 2018

Record last verified: 2018-09

Locations

FR (1)