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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02920463
Recruitment Status : Completed
First Posted : September 30, 2016
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent

Tracking Information
First Submitted Date August 26, 2016
First Posted Date September 30, 2016
Last Update Posted Date September 20, 2019
Actual Study Start Date October 1, 2016
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 29, 2016)
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02920463 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 29, 2016)
  • 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.
  • 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.
  • 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.
  • Duration of antimicrobial treatment for the infection under study in de-escalated patients versus non-deescalated patients [ Time Frame: 28 days ]
  • Duration of hospitalization on the intensive care unit in de-escalated patients versus non-deescalated patients [ Time Frame: 28 days ]
  • Number of antibiotic free days in de-escalated patients versus non-deescalated patients [ Time Frame: 28 days ]
  • Proportion of patients who died at day 28 in de-escalated patients versus non-deescalated patients [ Time Frame: 28 days ]
  • 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
  • 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.
  • Proportion of antimicrobial prescriptions in which a loading dose is used [ Time Frame: 28 days ]
  • Proportion of antimicrobial prescriptions which are administered in a continuous or extended infusion [ Time Frame: 28 days ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title DetermInants of Antimicrobial Use aNd De-escalAtion in Critical Care (DIANA)
Official Title DetermInants of Antimicrobial Use aNd De-escalAtion in Critical Care (DIANA Study)
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.
Detailed Description

Despite the consensus regarding spectrum and timing of antibiotic therapy, antimicrobial use varies across ICUs; indeed there are important variations in choice, dosing, method of administration, duration of antimicrobial therapy and de-escalation of empirical therapy. 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.

Given the explorative nature of this study the required number of patients was not calculated. The investigators aim to include 2000 patients in whom empirical antibiotics are started. With an estimated de-escalation rate of 35%, an estimation to include 700 patients in whom de-escalation is performed is made which would allow for a suitable multivariable analysis.

For each participating center center data will be collected as detailed in an electronic Center Report Form. This will be completed only once per center.

For each participating center data on 4 elements will be collected: ICU-related data, microbiology laboratory practices, definition of de-escalation as used in the participating center and local de-escalation practices, background resistance levels.

This is a prospective observational study in which patients will be included in the participating centers during a 2-week period.

For each patient included in the study, data will be collected in an electronic Case Report Form.

For each included patient data on 4 elements will be collected: patient data (demographics, underlying and co-morbid conditions, patient characteristics on different time points), infection data (clinical and microbiological), treatment data (antimicrobial therapy and source control) and outcome data (28 day follow up period)

National coordinators:

National Coordinators will be appointed by the Steering Committee and will have a key role in the conduction of the study in the individual countries as leaders of the project.

Ethics committee approval:

Ethics committee approval may vary from country to country. The national coordinator is responsible for obtaining ethics committee approval if this is required on a national level (or any procedure similar to this). Informed consent will be obtained from the subject or nominated representative (where applicable). As this is an observational study some countries and sites may waive the need for informed consent.

Data management:

All patient data will be collected anonymously and will be entered in an electronic data capturing system. 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.The servers of the system are hosted at True; True has been certified by the Lloyd's Register Quality Assurance (LRQA) according to the international information security norm ISO 27001:2013. True provides its services in accordance with the NEN7510 norm for information security in healthcare.

Data control:

Local investigators may be contacted for queries in case of outliers, excessive missing values and other reasons deemed relevant by the primary investigator.

Statistical analysis:

Statistical analysis will be performed by the primary investigators using a statistical software program and assisted by expert statisticians when necessary.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Infection
Intervention Not Provided
Study Groups/Cohorts Critically ill patients with infection
Critically ill adult patients receiving empirical antibiotic therapy for suspected or confirmed infections at the Intensive Care Unit
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 19, 2019)
1495
Original Estimated Enrollment
 (submitted: September 29, 2016)
2500
Actual Study Completion Date June 30, 2018
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT02920463
Other Study ID Numbers EC/2016/0938
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
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.
Responsible Party University Hospital, Ghent
Study Sponsor University Hospital, Ghent
Collaborators Not Provided
Investigators
Principal Investigator: Jan J De Waele, MD,PhD University Hospital, Ghent
PRS Account University Hospital, Ghent
Verification Date September 2019