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Trial record 22 of 257 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND broad

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

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ClinicalTrials.gov Identifier: NCT03664245
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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.


Condition or disease
Emergencies

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)


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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: DetermInants of Antimicrobial Use aNd De-escalAtion in Critical Care (DIANA Study)
Actual Study Start Date : December 11, 2017
Actual Primary Completion Date : December 31, 2017
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Group/Cohort
experimental group
Critically ill patients receiving empirical antibiotic therapy for suspected or confirmed infections at the Intensive Care Unit



Primary Outcome Measures :
  1. Antibiotic used [ Time Frame: 28 days ]
    analyse the list of antibiotics used during 28 days



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Critically ill patients receiving empirical antibiotic therapy for suspected or confirmed infections at the Intensive Care Unit
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03664245


Contacts
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Contact: MARC LEONE +33 491368655 Marc.LEONE@ap-hm.fr

Locations
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France
Assistance Publique Des Hopitaux de Marseille Recruiting
Marseille, Paca, France, 13354
Contact: MARC LEONE, MD    +33 491368655    Marc.LEONE@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: EMILIE GARRIDO PRADALIE, MD APHM

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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03664245     History of Changes
Other Study ID Numbers: 2017-20
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents