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

NCT02920463 | Completed

• 1 other identifier: EC/2016/0938
• Study Type: observational
• Target: 1,495
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection

Keywords

Anti-Infective agents; Antimicrobial stewardship; Empirical antibiotic therapy; De-escalation; Critical care

Outcome Measures

Primary Outcomes (2)

• Number of patients in which the empirical antibiotic therapy is de-escalated

  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.

  28 days

• Proportion of patients with clinical cure at day 7 in de-escalated patients versus non-deescalated patients

  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.

  7 days

Secondary Outcomes (11)

• Antibiotics used in empirical antimicrobial therapy in critically ill patients

  28 days

• Proportion of appropriate empirical antibiotic therapy in critically ill patients

  28 days

• Antibiotics used in definitive antimicrobial therapy in critically ill patients

  28 days

• Duration of antimicrobial treatment for the infection under study in de-escalated patients versus non-deescalated patients

  28 days

• Duration of hospitalization on the intensive care unit in de-escalated patients versus non-deescalated patients

  28 days

Study Arms (1)

Critically ill patients with infection

Critically ill adult 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: 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.

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 (Gram staining results may be known).
• Signed informed consent (if required by local ethics committee).

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent University Hospital

Ghent, Belgium

Location

Related Publications (3)

• Tabah A, Cotta MO, Garnacho-Montero J, Schouten J, Roberts JA, Lipman J, Tacey M, Timsit JF, Leone M, Zahar JR, De Waele JJ. A Systematic Review of the Definitions, Determinants, and Clinical Outcomes of Antimicrobial De-escalation in the Intensive Care Unit. Clin Infect Dis. 2016 Apr 15;62(8):1009-1017. doi: 10.1093/cid/civ1199. Epub 2015 Dec 23.

  PMID: 26703860 BACKGROUND

• Leone M, Bechis C, Baumstarck K, Lefrant JY, Albanese J, Jaber S, Lepape A, Constantin JM, Papazian L, Bruder N, Allaouchiche B, Bezulier K, Antonini F, Textoris J, Martin C; AZUREA Network Investigators. De-escalation versus continuation of empirical antimicrobial treatment in severe sepsis: a multicenter non-blinded randomized noninferiority trial. Intensive Care Med. 2014 Oct;40(10):1399-408. doi: 10.1007/s00134-014-3411-8. Epub 2014 Aug 5.

  PMID: 25091790 BACKGROUND

• Yoshida H, Motohashi T, De Bus L, De Waele J, Takaba A, Kuriyama A, Kobayashi A, Tanaka C, Hashi H, Hashimoto H, Nashiki H, Shibata M, Kanamoto M, Inoue M, Hashimoto S, Katayama S, Fujiwara S, Kameda S, Shindo S, Suzuki T, Komuro T, Kawagishi T, Kawano Y, Fujita Y, Kida Y, Hara Y, Fujitani S; DIANA Study Japanese group. Use of broad-spectrum antimicrobials for more than 72 h and the detection of multidrug-resistant bacteria in Japanese intensive care units: a multicenter retrospective cohort study. Antimicrob Resist Infect Control. 2022 Sep 29;11(1):119. doi: 10.1186/s13756-022-01146-3.

  PMID: 36175948 DERIVED

Related Links

• Click here for more information about this study: DetermInants of Antimicrobial use aNd de-escalAtion in critical care

MeSH Terms

Conditions

Infections

Study Officials

• Jan J De Waele, MD,PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 26, 2016
• First Posted: September 30, 2016
• Study Start: October 1, 2016
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: September 20, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)