DetermInants of Antimicrobial Use aNd De-escalAtion in Critical Care (DIANA) (DIANA)
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|ClinicalTrials.gov Identifier: NCT02920463|
Recruitment Status : Completed
First Posted : September 30, 2016
Last Update Posted : September 20, 2019
|Condition or disease|
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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 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.
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.
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 will be performed by the primary investigators using a statistical software program and assisted by expert statisticians when necessary.
|Study Type :||Observational|
|Actual Enrollment :||1495 participants|
|Official Title:||DetermInants of Antimicrobial Use aNd De-escalAtion in Critical Care (DIANA Study)|
|Actual Study Start Date :||October 1, 2016|
|Actual Primary Completion Date :||June 30, 2018|
|Actual Study Completion Date :||June 30, 2018|
Critically ill patients with infection
Critically ill adult patients receiving empirical antibiotic therapy for suspected or confirmed infections at the Intensive Care Unit
- 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.
- 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 ]
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
|Ghent University Hospital|
|Principal Investigator:||Jan J De Waele, MD,PhD||University Hospital, Ghent|