Critical CarePhase 3DéPOHNCT03683329
Antibiotic De-escalation in Onco-hematology Patients for Sepsis or Septic Shock
A Phase 3 study testing Antibiotic de-escalation and Standard treatment in people with Critical Care and Cancer, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
De-escalation aims at reducing the use of broad-spectrum antibiotics and therefore the emergence of multidrug-resistant (MDR) pathogens. Observational studies suggested that this strategy seems to be safe. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Care, Cancer
- What is being tested?
- Antibiotic de-escalation and Standard treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 398 participants
- Where
- 1 siteFrance
- Study dates
- 26 Nov 2018to 26 Jul 2024
- Phase
- Phase 3
- 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
Who may be able to join
- Written informed consent from the patient or proxy (if present) before inclusion or once possible when patient has been included in a context of emergency
- Age ≥ 18 years,
- Onco-hematology patient admitted to intensive care for sepsis or septic shock according to the following criteria:
- Sepsis:
- A suspected infection
- And an acute increase of ≥ 2 SOFA points (a proxy for organ dysfunction)
Show all 14Show fewer
- Septic shock:
- sepsis
- and vasopressor therapy needed to elevate MAP ≥65 mm Hg and lactate >2 mmol/L despite adequate fluid resuscitation
- Patient treated with an empirical antibiotic treatment,
- Patient with at least one microbiological sample collected at least within the first 48 hours following the diagnosis of sepsis in ICU
- Patient with an identified infectious site according to the definitions,
- Patient with an identified bacteria microorganism after microbiological examination,
- Patient affiliated to the national French statutory healthcare insurance system or beneficiary of this regimen.
Who cannot join
- Patient colonized with a multi-drug resistant organisms preventing de-escalation antibiotic,
- Pregnant or breast-feeding woman,
- No affiliation to the national French statutory healthcare insurance system,
- Patients deprived of liberty or placed under the authority of a tutor,
- Inappropriate probabilistic antibiotic treatment,
- Expected mortality within 48 hours,
- Patient admitted to the ICU for end-of-life care (do-not-resuscitate patients) . Do-not-intubate (DNI) patients can be included.
Trial locations and contacts
1 site in 1 country.
About this study
De-escalation aims at reducing the use of broad-spectrum antibiotics and therefore the emergence of multidrug-resistant (MDR) pathogens.
Observational studies suggested that this strategy seems to be safe. However, there is no adequate, direct evidence showing de-escalation of antimicrobial agents to be effective and safe for onco-hematology patients with sepsis or septic shock. Thus, randomized clinical trials are needed for testing the safety and efficiency of de-escalation of antimicrobial therapy.
Read more
The investigator's hypothesis is that de-escalation of empirical antimicrobial therapy in onco-hematology patients with sepsis or septic shock is noninferior to the continuation of empirical antimicrobial therapy.
The first aim of the study is to demonstrate that de-escalation is noninferior to the continuation of broad-spectrum antibiotics in terms of hospital mortality.
The secondary aims are to compare the two strategies in terms of mortality, duration of antimicrobial therapy, durations of mechanical ventilation, vasopressor use, numbers of superinfections, organ failure.
Antimicrobial de-escalation (ADE) of antimicrobial therapy is a strategy proposed to allow for the rational use of broad-spectrum antimicrobial therapy as the empiric treatment for infections and minimize the overall exposure to these broad-spectrum agents. The need for prompt, effective antimicrobial therapy for patients with known or suspected infections is widely accepted. This principle leads to the use of very broad-spectrum antimicrobial therapy to increase the odds that all suspected potential pathogens are adequately treated. However, the potential drawback is selection of multidrug-resistant (MDR) organisms.
ADE is widely recommended in the management of antimicrobial therapy in intensive care unit (ICU) patients. The Surviving Sepsis Campaign guidelines describe and recommend the process for selecting antimicrobial therapy as commencement of antimicrobials within the first hour, antimicrobial therapy broad enough to cover all likely pathogens, and daily reassessment for potential ADE.
To date, no randomized study assessing this strategy is available for this specific population of cancer critically ill patients. In a recent systematic review based on 13 observational studies and one randomized controlled trial, the authors conclude that the equipoise remains and a large randomized trial is required to assess the effect of the antibiotics de-escalation strategy on the bacterial ecosystem, on MDR carriage, and on patient outcomes.
Read the detailed description
An interim analysis planned after inclusion of 233 patients.
- Subgroup analyses will be performed on patient subsets:
- Patients with allogeneic hematopoietic stem cell transplant,
- Neutropenic patients (Neutrophils < 0.5 Giga/L),
- Hematological disease,
- Oncological disease,
- Polymicrobial sepsis,
- Multi-drug resistant organisms,
- Patients presenting with bacterial pneumoniae,
- Patients presenting with Intra-abdominal infection,
- Patients presenting with bacteraemia,
- Patients presenting with gram negative bacteria infection,
- Patients presenting with gram positive cocci infection,
- Patients presenting with septic shock,
- Patients presenting with sepsis.
- Conditions
- Critical Care, Cancer
- Being tested
- Antibiotic de-escalation, Standard treatment
- Keywords
- critical care, cancer, antimicrobial treatment, de-escalation, septic shock, sepsis
- Medical subject headings
- Neoplasms, Shock, Septic, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotic de-escalationOther
All the therapeutic protocols made the object of a consensus between the different partners of the study.
Antibiotic treatment will be delivered according to current practice, in agreement with the national and international recommendation.
Standard treatmentOther
Antibiotic treatment will be delivered according to current practice, in agreement with the national and international recommendation.
| Study group | Role | What they receive |
|---|---|---|
| Antibiotic de-escalation | Experimental | * According to the results of the antibiogram of the suspected causative bacteria, the ''pivotal'' antibiotic (antipseudomonal betalactam) used for empirical treatment is switched to an antibiotic with a spectrum as narrow as possible according to the targeted pathogens,
* Stop the companion antibiotic (aminoglycoside, fluoroquinolone, macrolide) between day 2 and day 3 of antibiotic treatment as much as possible,
* Stop the empirical antibiotic directed against methicillin-resistant staphylococcus aureus (MRSA) or an enterococcus in the absence of these bacteria in the culture. Receives: Other: Antibiotic de-escalation |
| Standard treatment without de-escalation | Active comparator | * The companion antibiotic is stopped between day 3 and day 5 of antibiotic treatment as much as possible and according to the local prescription,
* Empirical antibiotics directed against MRSA or enterococcus were used according to local prescription and/or international guidelines,
* The pivotal antibiotic of the empirical treatment is continued for the entire duration of the treatment, independently of microbiological results. For prolonged treatment, the physician has the choice of de-escalating after 8-15 days of treatment. Receives: Other: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital mortality
death from any cause during hospital stay
Measured: From day of inclusion until day of ICU discharge, up to 3 months
Secondary outcomes (44)
Death
death from any cause into the ICU, day 28 and day 90
Measured: From day of inclusion until ICU discharge, day 28 and day 90
ICU length of stay
Measured: From day of inclusion until ICU discharge (until day 90)
Hospital length of stay
Measured: From day of inclusion until ICU discharge (until day 90)
Severe organ dysfunctions
A Sepsis-related Organ Failure Assessment (SOFA) score>2 for each organ (respiratory, hematologic, cardiac, neurologic, hepatic, renal)
Measured: From day of inclusion until ICU discharge (until day 90)
Respiratory dysfunction-free days at day 28
days without respiratory dysfunction (respiratory SOFA score<3)
Measured: from inclusion to day 28
Renal dysfunction-free days at day 28
days without renal dysfunction (renal SOFA score<3)
Measured: from inclusion to day 28
Neurologic dysfunction-free days at day 28
days without neurologic dysfunction (neurologic SOFA score<3)
Measured: from inclusion to day 28
Cardiac dysfunction-free days at day 28
days without cardiac dysfunction (cardiac SOFA score<3)
Measured: from inclusion to day 28
Hepatic dysfunction-free days at day 28
days without hepatic dysfunction (hepatic SOFA score<3)
Measured: From inclusion to day 28
Hematologic dysfunction-free days at day 28
days without hematologic dysfunction (hematologic SOFA score<3)
Measured: From inclusion to day 28
Ventilator-free days at day 28
days without invasive mechanical ventilation
Measured: From inclusion to day 28
Vasopressors-free days at day 28
days without vasopressors treatment
Measured: From inclusion to day 28
Dialysis-free days at day 28
days without dialysis treatment
Measured: From inclusion to day 28
Duration of antibiotic treatment during ICU stay
Duration between the first antibiotic initiation and the last antibiotic stop
Measured: From day of admission to ICU until day 90
Number of antibiotics de-escalated
Number of antibiotics de-escalated in each arm
Measured: From inclusion to ICU discharge until day 90
Number of antifungal de-escalated
Number of antifungal de-escalated in each arm
Measured: From inclusion to ICU discharge until day 90
Number of antiviral de-escalated
Number of antiviral de-escalated in each arm
Measured: From inclusion to ICU discharge until day 90
Antibiotic-free days at day 28
days without antibiotic treatment
Measured: From inclusion to day 28
Antibiotic-free days during ICU stay
days without antibiotic treatment
Measured: From admission to ICU to ICU discharge until day 90
Antibiotic-free days during hospital stay
Days without antibiotic treatment
Measured: From admission to ICU to hospital discharge until day 90
Antibiotic-free days at day 90
Days without antibiotic treatment
Measured: From admission to ICU to day 90
Antifungal-free days at day 28
Days without antifungal treatment
Measured: From admission to ICU to day 28
Antiviral-free days at day 28
Days without antiviral treatment
Measured: From admission to ICU to day 28
Antifungal-free days during ICU stay
Days without antifungal treatment
Measured: From admission to ICU to ICU discharge until day 90
Antiviral-free days during ICU stay
Days without antiviral treatment
Measured: From admission to ICU to ICU discharge until day 90
Antiviral-free days during hospital stay
Days without antiviral treatment
Measured: From admission to ICU to hospital discharge until day 90
Antifungal-free days during hospital stay
Days without antifungal treatment
Measured: From admission to ICU to hospital discharge until day 90
Antifungal-free days at day 90
Days without antifungal treatment
Measured: From admission to ICU to day 90
Antiviral-free days at day 90
Days without antiviral treatment
Measured: From admission to ICU to day 90
Number of days of exposure to each antibiotic per 1000 inpatient days
For the entire cohort:(number of antibiotic days / number of ICU days)*1000
Measured: From admission to ICU to ICU discharge until day 90
Number of days of exposure to each antifungal per 1000 inpatient days
For the entire cohort:(number of antifungal days / number of ICU days)*1000
Measured: From admission to ICU to ICU discharge until day 90
Number of days of exposure to each antiviral per 1000 inpatient days
For the entire cohort:(number of antiviral days / number of ICU days)*1000
Measured: From admission to ICU to ICU discharge until day 90
Adverse events
Adverse events assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0
Measured: From inclusion to ICU discharge until day 90
Compliance to de-escalation strategy
number of patients de-escalated/number of patients included in the experimental arm
Measured: From inclusion to ICU discharge until day 90
Compliance to the continuation strategy
number of patients not de-escalated/number of patients included in the continuation group
Measured: From inclusion to ICU discharge until day 90
Percentage of emerging multidrug-resistant bacteria
Percentage of emerging multidrug-resistant bacteria isolated from specimen taken for routine microbiological assessments
Measured: From inclusion until day 28
Cost of antibiotic treatment
Measured: From inclusion to ICU discharge until day 90
Patients presenting with bacterial pneumoniae,
Measured: From inclusion to ICU discharge until day 90
Patients presenting with Intra-abdominal infection.
Measured: From inclusion to ICU discharge until day 90
Patients presenting with bacteraemia
Measured: From inclusion to ICU discharge until day 90
Number of patients in the de-escalation group without de-escalation
Measured: From inclusion to ICU discharge until day 90
Rate of new infectious episode requiring a new antibiotic treatment
Measured: From inclusion to ICU discharge until day 90
Rate of patients requiring an escalation after de-escalation
Measured: From inclusion to ICU discharge until day 90
Rate of recovery from infection
Measured: From inclusion to ICU discharge until day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start26 Nov 2018
- Primary completion26 Jul 2024
- Study completion26 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical CareStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 398 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MOKART Djamel, MD, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03683329
- Sponsor's protocol ID
- DéPOH-IPC 2015-022
- Acronym
- DéPOH
- Status last verified
- Feb 2026
- First submitted
- 12 Aug 2018
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic De-escalation in Onco-hematology Patients for Sepsis or Septic Shock
- ClinicalTrials.gov ID
- NCT03683329
- Acronym / sponsor ID
- DéPOH / DéPOH-IPC 2015-022
- Conditions
- Critical Care, Cancer
- Keywords
- critical care, cancer, antimicrobial treatment, de-escalation, septic shock, sepsis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 398 participants (actual)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- 26 Jul 2024 (actual)
- Study completion
- 26 Jul 2024 (actual)
- First posted
- 25 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.
De-escalation aims at reducing the use of broad-spectrum antibiotics and therefore the emergence of multidrug-resistant (MDR) pathogens.
Observational studies suggested that this strategy seems to be safe. However, there is no adequate, direct evidence showing de-escalation of antimicrobial agents to be effective and safe for onco-hematology patients with sepsis or septic shock. Thus, randomized clinical trials are needed for testing the safety and efficiency of de-escalation of antimicrobial therapy.
The investigator's hypothesis is that de-escalation of empirical antimicrobial therapy in onco-hematology patients with sepsis or septic shock is noninferior to the continuation of empirical antimicrobial therapy.
The first aim of the study is to demonstrate that de-escalation is noninferior to the continuation of broad-spectrum antibiotics in terms of hospital mortality.
The secondary aims are to compare the two strategies in terms of mortality, duration of antimicrobial therapy, durations of mechanical ventilation, vasopressor use, numbers of superinfections, organ failure.
Antimicrobial de-escalation (ADE) of antimicrobial therapy is a strategy proposed to allow for the rational use of broad-spectrum antimicrobial therapy as the empiric treatment for infections and minimize the overall exposure to these broad-spectrum agents. The need for prompt, effective antimicrobial therapy for patients with known or suspected infections is widely accepted. This principle leads to the use of very broad-spectrum antimicrobial therapy to increase the odds that all suspected potential pathogens are adequately treated. However, the potential drawback is selection of multidrug-resistant (MDR) organisms.
ADE is widely recommended in the management of antimicrobial therapy in intensive care unit (ICU) patients. The Surviving Sepsis Campaign guidelines describe and recommend the process for selecting antimicrobial therapy as commencement of antimicrobials within the first hour, antimicrobial therapy broad enough to cover all likely pathogens, and daily reassessment for potential ADE.
To date, no randomized study assessing this strategy is available for this specific population of cancer critically ill patients. In a recent systematic review based on 13 observational studies and one randomized controlled trial, the authors conclude that the equipoise remains and a large randomized trial is required to assess the effect of the antibiotics de-escalation strategy on the bacterial ecosystem, on MDR carriage, and on patient outcomes.
Detailed description
An interim analysis planned after inclusion of 233 patients.
- Subgroup analyses will be performed on patient subsets:
- Patients with allogeneic hematopoietic stem cell transplant,
- Neutropenic patients (Neutrophils < 0.5 Giga/L),
- Hematological disease,
- Oncological disease,
- Polymicrobial sepsis,
- Multi-drug resistant organisms,
- Patients presenting with bacterial pneumoniae,
- Patients presenting with Intra-abdominal infection,
- Patients presenting with bacteraemia,
- Patients presenting with gram negative bacteria infection,
- Patients presenting with gram positive cocci infection,
- Patients presenting with septic shock,
- Patients presenting with sepsis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotic de-escalation | Experimental | Other: Antibiotic de-escalation* According to the results of the antibiogram of the suspected causative bacteria, the ''pivotal'' antibiotic (antipseudomonal betalactam) used for empirical treatment is switched to an antibiotic with a spectrum as narrow as possible according to the targeted pathogens, * Stop the companion antibiotic (aminoglycoside, fluoroquinolone, macrolide) between day 2 and day 3 of antibiotic treatment as much as possible, * Stop the empirical antibiotic directed against methicillin-resistant staphylococcus aureus (MRSA) or an enterococcus in the absence of these bacteria in the culture. |
| Standard treatment without de-escalation | Active comparator | Other: Standard treatment* The companion antibiotic is stopped between day 3 and day 5 of antibiotic treatment as much as possible and according to the local prescription, * Empirical antibiotics directed against MRSA or enterococcus were used according to local prescription and/or international guidelines, * The pivotal antibiotic of the empirical treatment is continued for the entire duration of the treatment, independently of microbiological results. For prolonged treatment, the physician has the choice of de-escalating after 8-15 days of treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Written informed consent from the patient or proxy (if present) before inclusion or once possible when patient has been included in a context of emergency
- Age ≥ 18 years,
- Onco-hematology patient admitted to intensive care for sepsis or septic shock according to the following criteria:
- Patient treated with an empirical antibiotic treatment,
- Patient with at least one microbiological sample collected at least within the first 48 hours following the diagnosis of sepsis in ICU
Key exclusion criteria (7 listed)
- Patient colonized with a multi-drug resistant organisms preventing de-escalation antibiotic,
- Pregnant or breast-feeding woman,
- No affiliation to the national French statutory healthcare insurance system,
- Patients deprived of liberty or placed under the authority of a tutor,
- Inappropriate probabilistic antibiotic treatment,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antibiotic de-escalationAll the therapeutic protocols made the object of a consensus between the different partners of the study. Antibiotic treatment will be delivered according to current practice, in agreement with the national and international recommendation. | Other | Antibiotic de-escalation |
| Standard treatmentAntibiotic treatment will be delivered according to current practice, in agreement with the national and international recommendation. | Other | Standard treatment without de-escalation |
Primary outcome
Hospital mortality
Time frame: From day of inclusion until day of ICU discharge, up to 3 months
death from any cause during hospital stay
44 secondary outcomes
Death
Time frame: From day of inclusion until ICU discharge, day 28 and day 90
ICU length of stay
Time frame: From day of inclusion until ICU discharge (until day 90)
Hospital length of stay
Time frame: From day of inclusion until ICU discharge (until day 90)
Severe organ dysfunctions
Time frame: From day of inclusion until ICU discharge (until day 90)
Respiratory dysfunction-free days at day 28
Time frame: from inclusion to day 28
Renal dysfunction-free days at day 28
Time frame: from inclusion to day 28
Neurologic dysfunction-free days at day 28
Time frame: from inclusion to day 28
Cardiac dysfunction-free days at day 28
Time frame: from inclusion to day 28
Hepatic dysfunction-free days at day 28
Time frame: From inclusion to day 28
Hematologic dysfunction-free days at day 28
Time frame: From inclusion to day 28
Ventilator-free days at day 28
Time frame: From inclusion to day 28
Vasopressors-free days at day 28
Time frame: From inclusion to day 28
Dialysis-free days at day 28
Time frame: From inclusion to day 28
Duration of antibiotic treatment during ICU stay
Time frame: From day of admission to ICU until day 90
Number of antibiotics de-escalated
Time frame: From inclusion to ICU discharge until day 90
Number of antifungal de-escalated
Time frame: From inclusion to ICU discharge until day 90
Number of antiviral de-escalated
Time frame: From inclusion to ICU discharge until day 90
Antibiotic-free days at day 28
Time frame: From inclusion to day 28
Antibiotic-free days during ICU stay
Time frame: From admission to ICU to ICU discharge until day 90
Antibiotic-free days during hospital stay
Time frame: From admission to ICU to hospital discharge until day 90
Antibiotic-free days at day 90
Time frame: From admission to ICU to day 90
Antifungal-free days at day 28
Time frame: From admission to ICU to day 28
Antiviral-free days at day 28
Time frame: From admission to ICU to day 28
Antifungal-free days during ICU stay
Time frame: From admission to ICU to ICU discharge until day 90
Antiviral-free days during ICU stay
Time frame: From admission to ICU to ICU discharge until day 90
Antiviral-free days during hospital stay
Time frame: From admission to ICU to hospital discharge until day 90
Antifungal-free days during hospital stay
Time frame: From admission to ICU to hospital discharge until day 90
Antifungal-free days at day 90
Time frame: From admission to ICU to day 90
Antiviral-free days at day 90
Time frame: From admission to ICU to day 90
Number of days of exposure to each antibiotic per 1000 inpatient days
Time frame: From admission to ICU to ICU discharge until day 90
Number of days of exposure to each antifungal per 1000 inpatient days
Time frame: From admission to ICU to ICU discharge until day 90
Number of days of exposure to each antiviral per 1000 inpatient days
Time frame: From admission to ICU to ICU discharge until day 90
Adverse events
Time frame: From inclusion to ICU discharge until day 90
Compliance to de-escalation strategy
Time frame: From inclusion to ICU discharge until day 90
Compliance to the continuation strategy
Time frame: From inclusion to ICU discharge until day 90
Percentage of emerging multidrug-resistant bacteria
Time frame: From inclusion until day 28
Cost of antibiotic treatment
Time frame: From inclusion to ICU discharge until day 90
Patients presenting with bacterial pneumoniae,
Time frame: From inclusion to ICU discharge until day 90
Patients presenting with Intra-abdominal infection.
Time frame: From inclusion to ICU discharge until day 90
Patients presenting with bacteraemia
Time frame: From inclusion to ICU discharge until day 90
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 19 Feb 2026.
- Institut Paoli-CalmettesLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Critical Care
Enrolling by invitationObservational study
WSACS 2026 Delphi Consensus on the Practical Management of Intra-abdominal Hypertension and Abdominal Compartment Syndrome
Intra-Abdominal Hypertension, Abdominal Compartment Syndrome
Not yet recruitingPhase 4
Ceftriaxone Dosage for Non-Critical Community-Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 3
Canadian Critical Care Comparative Effectiveness Platform
Intensive Care Unit ICU, Vasopressor
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
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.
MOKART Djamel, MD principal investigator
Institut Paoli-Calmettes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Antibiotic de-escalation and Standard treatment in people with Critical Care and Cancer, run by Institut Paoli-Calmettes 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 14 inclusion and 7 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 19 Feb 2026. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Hospital mortality (time frame: From day of inclusion until day of ICU discharge, up to 3 months). 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 19 Feb 2026.