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

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ClinicalTrials.gov Identifier: NCT02920463
Recruitment Status : Recruiting
First Posted : September 30, 2016
Last Update Posted : May 21, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent

Brief Summary:
DetermInants of Antimicrobial use aNd de-escalAtion in critical care (DIANA study), is a multicenter, international, prospective, observational cohort study, aiming to describe the rate of de-escalation as well as the associated outcome and the empirical antibiotic therapy for infections at the intensive care unit.

Condition or disease
Infection

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 2500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: DetermInants of Antimicrobial Use aNd De-escalAtion in Critical Care (DIANA Study)
Study Start Date : October 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Number of patients in which the empirical antibiotic therapy is de-escalated [ Time Frame: 28 days ]
    Included patients will be monitored for 28 days. This is the number of patients in which the empirical antibiotic therapy is de-escalated during the time of observation.

  2. Proportion of patients with clinical cure at day 7 in de-escalated patients versus non-deescalated patients [ Time Frame: 7 days ]
    This is the proportion of patients in which the infection under study is clinically cured, which is defined as: 'disappearance of all signs and symptoms related to the infection under study' in de-escalated versus non-deescalated patients.


Secondary Outcome Measures :
  1. Antibiotics used in empirical antimicrobial therapy in critically ill patients [ Time Frame: 28 days ]
    Which antibiotic categories are chosen empirically to treat the infection under study in all critically ill patients included during the study period.

  2. Proportion of appropriate empirical antibiotic therapy in critically ill patients [ Time Frame: 28 days ]
    This is the proportion of all empirical antibiotic prescriptions that has in-vitro activity against all causative pathogens.

  3. Antibiotics used in definitive antimicrobial therapy in critically ill patients [ Time Frame: 28 days ]
    Which antibiotic categories are chosen as definitive antimicrobial therapy to treat the infection under study in all critically ill patients included during the study period.

  4. Duration of antimicrobial treatment for the infection under study in de-escalated patients versus non-deescalated patients [ Time Frame: 28 days ]
  5. Duration of hospitalization on the intensive care unit in de-escalated patients versus non-deescalated patients [ Time Frame: 28 days ]
  6. Number of antibiotic free days in de-escalated patients versus non-deescalated patients [ Time Frame: 28 days ]
  7. Proportion of patients who died at day 28 in de-escalated patients versus non-deescalated patients [ Time Frame: 28 days ]
  8. Proportion of patients in whom drug-resistant pathogens emerge in de-escalated patients versus non-deescalated patients [ Time Frame: 28 days ]
    Included patients will be monitored for 28 days. This is the proportion of multidrug resistant, extensively drug-resistant, pandrug- resistant pathogens and pathogens resistant to the administered empirical antibiotic therapy that emerge in de-escalated patients versus non-deescalated patients

  9. Proportion of patients with infection relapse, superinfections and subsequent infections in de-escalated patients versus non-deescalated patients [ Time Frame: 28 days ]

    Infection relapse being defined as an infection occurring after stopping all antimicrobial agents for the primary infection under study with the same causative microorganism (a different susceptibility pattern may be present).

    Subsequent infection being defined as an infection occurring after stopping all antimicrobial agents for the primary infection under study, with a different causative microorganism.

    Superinfection being defined as an infection superimposed on the primary infection under study with a different causative microorganism.


  10. Proportion of antimicrobial prescriptions in which a loading dose is used [ Time Frame: 28 days ]
  11. Proportion of antimicrobial prescriptions which are administered in a continuous or extended infusion [ Time Frame: 28 days ]


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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:   Probability Sample
Study Population
All patients admitted to the intensive care unit during a 2-week period between October 2016 and December 2017. Participating centers can select the weeks of participation based on local considerations and staff availability.All consecutive patients that are eligible according to inclusion and exclusion criteria should be included in the study.
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 (Gram staining results may be known).
  • Signed informed consent (if required by local ethics committee).

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): NCT02920463


Contacts
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Contact: Liesbet De Bus, MD +3293321565 Liesbet.DeBus@UGent.be
Contact: Jan J De Waele, MD,PhD +3293326219 Jan.DeWaele@UGent.be

Locations
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Belgium
Ghent University Hospital Recruiting
Ghent, Belgium
Contact: Liesbet De Bus, MD         
Sponsors and Collaborators
University Hospital, Ghent
Investigators
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Principal Investigator: Jan J De Waele, MD,PhD University Hospital, Ghent

Additional Information:
Publications:
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Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT02920463     History of Changes
Other Study ID Numbers: EC/2016/0938
First Posted: September 30, 2016    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared with participating centers only. Data provided by the local investigators are primarily the property of the ICU that collected the data. Local investigators shall have access to their data after they have been entered in the central database.

Keywords provided by University Hospital, Ghent:
Anti-Infective agents
Antimicrobial stewardship
Empirical antibiotic therapy
De-escalation
Critical care

Additional relevant MeSH terms:
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Anti-Bacterial Agents
Anti-Infective Agents