EmergenciesDIANANCT03664245
DetermInants of Antimicrobial Use aNd De-escalAtion in Critical Care
An observational study of Emergencies, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Appropriate initial antibiotic therapy is crucial in the treatment of severe infections in patients with intensive care. Adequate spectrum and appropriate doses are the keys to achieving the therapeutic goal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergencies
- How many people
- 2,000 participants
- Where
- 1 siteFrance
- Study dates
- 11 Dec 2017to Nov 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: Critically ill patients receiving empirical antibiotic therapy for suspected or confirmed infections at the Intensive Care Unit
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.
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.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Des Hopitaux de Marseille
Marseille, PACA, 13354
MARC LEONE, MD, +33 491368655, Marc.LEONE@ap-hm.fr
About this study
Official title: DetermInants of Antimicrobial Use aNd De-escalAtion in Critical Care (DIANA Study)
Appropriate initial antibiotic therapy is crucial in the treatment of severe infections in patients with intensive care. Adequate spectrum and appropriate doses are the keys to achieving the therapeutic goal. Despite broad consensus on the spectrum and timing of antimicrobial therapy, antibiotic use varies according to various parameters including choice, dose, method of administration, duration of antibiotic therapy and de-escalation. an empirical attitude.
Therapeutic de-escalation is considered essential for the use of antibiotics and is now clearly established by different consensus. However, routine de-escalation has recently been questioned in a randomized, controlled study that did not demonstrate non-inferiority of de-escalation with an increase in the number of days of antibiotic therapy associated with an increased number of days. superinfection.
Read more
The components of the de-escalation described in the literature, are based on the reduction of the number of antibiotics, the strict observance of the spectrum of the antibiotic, the reduction of use of the antibiotic, the stopping of any inappropriate antibiotic treatment ( lack of in vitro activity).
De-escalation can be considered in different ways; there are significant variations between hospitals, countries, teams. A large European multicenter cohort is needed.
The main objective of this study is to describe empiric antibiotic therapy in intensive care and the modalities of de-escalation.
Read the detailed description
Appropriate initial antibiotic therapy is crucial in the treatment of severe infections in patients with intensive care. Adequate spectrum and appropriate doses are the keys to achieving the therapeutic goal. Despite broad consensus on the spectrum and timing of antimicrobial therapy, antibiotic use varies according to various parameters including choice, dose, method of administration, duration of antibiotic therapy and de-escalation. an empirical attitude.
Therapeutic de-escalation is considered essential for the use of antibiotics and is now clearly established by different consensus. However, routine de-escalation has recently been questioned in a randomized, controlled study that did not demonstrate non-inferiority of de-escalation with an increase in the number of days of antibiotic therapy associated with an increased number of days. superinfection.
The components of the de-escalation described in the literature, are based on the reduction of the number of antibiotics, the strict observance of the spectrum of the antibiotic, the reduction of use of the antibiotic, the stopping of any inappropriate antibiotic treatment ( lack of in vitro activity).
De-escalation can be considered in different ways; there are significant variations between hospitals, countries, teams. A large European multicenter cohort is needed.
The main objective of this study is to describe empiric antibiotic therapy in intensive care and the modalities of de-escalation (rate of de-escalation, incidence of mortality, length of stay in intensive care unit, relapse, rate of superinfection)
- Conditions
- Emergencies
- Medical subject headings
- Emergencies
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 |
|---|---|---|
| experimental group | Critically ill 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.
Antibiotic used
analyse the list of antibiotics used during 28 days
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 posted10 Sep 2018
- Study start11 Dec 2017
- Primary completion31 Dec 2017
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmergenciesStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- EMILIE GARRIDO PRADALIE, MD, Study director, APHM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03664245
- Sponsor's protocol ID
- 2017-20
- Acronym
- DIANA
- Status last verified
- Sep 2018
- First submitted
- 7 Sep 2018
- Last updated
- 10 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. 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
- NCT03664245
- Acronym / sponsor ID
- DIANA / 2017-20
- Conditions
- Emergencies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 11 Dec 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- Nov 2018 (estimated)
- First posted
- 10 Sep 2018 (actual)
- 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.
Appropriate initial antibiotic therapy is crucial in the treatment of severe infections in patients with intensive care. Adequate spectrum and appropriate doses are the keys to achieving the therapeutic goal. Despite broad consensus on the spectrum and timing of antimicrobial therapy, antibiotic use varies according to various parameters including choice, dose, method of administration, duration of antibiotic therapy and de-escalation. an empirical attitude.
Therapeutic de-escalation is considered essential for the use of antibiotics and is now clearly established by different consensus. However, routine de-escalation has recently been questioned in a randomized, controlled study that did not demonstrate non-inferiority of de-escalation with an increase in the number of days of antibiotic therapy associated with an increased number of days. superinfection.
The components of the de-escalation described in the literature, are based on the reduction of the number of antibiotics, the strict observance of the spectrum of the antibiotic, the reduction of use of the antibiotic, the stopping of any inappropriate antibiotic treatment ( lack of in vitro activity).
De-escalation can be considered in different ways; there are significant variations between hospitals, countries, teams. A large European multicenter cohort is needed.
The main objective of this study is to describe empiric antibiotic therapy in intensive care and the modalities of de-escalation.
Detailed description
Appropriate initial antibiotic therapy is crucial in the treatment of severe infections in patients with intensive care. Adequate spectrum and appropriate doses are the keys to achieving the therapeutic goal. Despite broad consensus on the spectrum and timing of antimicrobial therapy, antibiotic use varies according to various parameters including choice, dose, method of administration, duration of antibiotic therapy and de-escalation. an empirical attitude.
Therapeutic de-escalation is considered essential for the use of antibiotics and is now clearly established by different consensus. However, routine de-escalation has recently been questioned in a randomized, controlled study that did not demonstrate non-inferiority of de-escalation with an increase in the number of days of antibiotic therapy associated with an increased number of days. superinfection.
The components of the de-escalation described in the literature, are based on the reduction of the number of antibiotics, the strict observance of the spectrum of the antibiotic, the reduction of use of the antibiotic, the stopping of any inappropriate antibiotic treatment ( lack of in vitro activity).
De-escalation can be considered in different ways; there are significant variations between hospitals, countries, teams. A large European multicenter cohort is needed.
The main objective of this study is to describe empiric antibiotic therapy in intensive care and the modalities of de-escalation (rate of de-escalation, incidence of mortality, length of stay in intensive care unit, relapse, rate of superinfection)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | – | –Critically ill 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
- Critically ill patients receiving empirical antibiotic therapy for suspected or confirmed infections at the Intensive Care Unit
Key inclusion criteria (5 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.
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
Antibiotic used
Time frame: 28 days
analyse the list of antibiotics used during 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
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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.
EMILIE GARRIDO PRADALIE, MD study director
APHM
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 Emergencies, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 5 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: status not confirmed, as of the sponsor's last update on 10 Sep 2018. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MARC LEONE (+33 491368655, Marc.LEONE@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibiotic used (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2018.