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DetermInants of Antimicrobial Use aNd De-escalAtion in Critical Care

DetermInants of Antimicrobial Use aNd De-escalAtion in Critical Care (DIANA Study)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03664245
Acronym
DIANA
Enrollment
2000
Registered
2018-09-10
Start date
2017-12-11
Completion date
2018-11-30
Last updated
2018-09-10

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

Conditions

Emergencies

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.

Detailed description

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 (rate of de-escalation, incidence of mortality, length of stay in intensive care unit, relapse, rate of superinfection)

Interventions

None listed

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

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

Inclusion criteria

* 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.

Exclusion criteria

* Previous inclusion in this study for another infection - each patient can only be included once.

Design outcomes

Primary

MeasureTime frameDescription
Antibiotic used28 daysanalyse the list of antibiotics used during 28 days

Countries

France

Contacts

Primary ContactMARC LEONE
Marc.LEONE@ap-hm.fr+33 491368655

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026