InfectionDIANANCT02920463
DetermInants of Antimicrobial Use aNd De-escalAtion in Critical Care (DIANA)
An observational study of Infection, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection
- How many people
- 1,495 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2016to 30 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- Previous inclusion in this study for another infection - each patient can only be included once.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DetermInants of Antimicrobial Use aNd De-escalAtion in Critical Care (DIANA Study)
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.
Read the 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.
- Conditions
- Infection
- Keywords
- Anti-Infective agents, Antimicrobial stewardship, Empirical antibiotic therapy, De-escalation, Critical care
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Critically ill patients with infection | Critically ill adult patients receiving empirical antibiotic therapy for suspected or confirmed infections at the Intensive Care Unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 7 days
Secondary outcomes (11)
Antibiotics used in empirical antimicrobial therapy in critically ill patients
Which antibiotic categories are chosen empirically to treat the infection under study in all critically ill patients included during the study period.
Measured: 28 days
Proportion of appropriate empirical antibiotic therapy in critically ill patients
This is the proportion of all empirical antibiotic prescriptions that has in-vitro activity against all causative pathogens.
Measured: 28 days
Antibiotics used in definitive antimicrobial therapy in critically ill patients
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.
Measured: 28 days
Duration of antimicrobial treatment for the infection under study in de-escalated patients versus non-deescalated patients
Measured: 28 days
Duration of hospitalization on the intensive care unit in de-escalated patients versus non-deescalated patients
Measured: 28 days
Number of antibiotic free days in de-escalated patients versus non-deescalated patients
Measured: 28 days
Proportion of patients who died at day 28 in de-escalated patients versus non-deescalated patients
Measured: 28 days
Proportion of patients in whom drug-resistant pathogens emerge in de-escalated patients versus non-deescalated patients
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
Measured: 28 days
Proportion of patients with infection relapse, superinfections and subsequent infections in de-escalated patients versus non-deescalated patients
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.
Measured: 28 days
Proportion of antimicrobial prescriptions in which a loading dose is used
Measured: 28 days
Proportion of antimicrobial prescriptions which are administered in a continuous or extended infusion
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study start1 Oct 2016
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,495 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan J De Waele, MD,PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02920463
- Sponsor's protocol ID
- EC/2016/0938
- Acronym
- DIANA
- Status last verified
- Sep 2019
- First submitted
- 26 Aug 2016
- Last updated
- 20 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 26703860Leone 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.
PubMed 25091790Yoshida 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.
PubMed 36175948
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DetermInants of Antimicrobial Use aNd De-escalAtion in Critical Care (DIANA Study)
- ClinicalTrials.gov ID
- NCT02920463
- Acronym / sponsor ID
- DIANA / EC/2016/0938
- Conditions
- Infection
- Keywords
- Anti-Infective agents, Antimicrobial stewardship, Empirical antibiotic therapy, De-escalation, Critical care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,495 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 30 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill patients with infection | – | –Critically ill adult patients receiving empirical antibiotic therapy for suspected or confirmed infections at the Intensive Care Unit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (1 listed)
- Previous inclusion in this study for another infection - each patient can only be included once.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
11 secondary outcomes
Antibiotics used in empirical antimicrobial therapy in critically ill patients
Time frame: 28 days
Proportion of appropriate empirical antibiotic therapy in critically ill patients
Time frame: 28 days
Antibiotics used in definitive antimicrobial therapy in critically ill patients
Time frame: 28 days
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
Proportion of patients with infection relapse, superinfections and subsequent infections in de-escalated patients versus non-deescalated patients
Time frame: 28 days
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
- Background: PubMed 26703860Tabah 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.
- Background: PubMed 25091790Leone 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.
- Derived from this study: PubMed 36175948Yoshida 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.
- Click here for more information about this study: DetermInants of Antimicrobial use aNd de-escalAtion in critical careLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan J De Waele, MD,PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients in which the empirical antibiotic therapy is de-escalated (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02920463, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2019.