BridgeMD
New treatment option for Sepsis
Official title Rapid Recognition of Corticosteroid Resistant or Sensitive Sepsis
ClinicalTrials.gov ID: NCT04280497
What this study is testing
What is Administration procedures?
Administration procedures is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for sepsis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Main objective and primary endpoint: To compare the effect hydrocortisone plus fludrocortisone vs. placebo on a composite of death or persistent organ dysfunction - defined as continued dependency on mechanical ventilation, new renal replacement therapy, or vasopressors - assessed at 90 days on intensive care unit (ICU) adults and having different biological profiles for immune responses and corticosteroids bioactivity.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient ≥18 years old;
- Admitted to ICU with proven or suspected infection as the main diagnosis;
- Community acquired pneumonia related sepsis or vasopressors dependency (norepinephrine, epinephrine, vasopressin, dopamine, phenylephrine) or septic...
- Patients who have been tested for one or more RECORDS specific biomarkers:
- CIRCI
You likely can't join if
- Pregnancy;
- Expected death or withdrawal of life-sustaining treatments within 48 hours;
- Previously enrolled in this study
- Formal indication for corticosteroids according to most recent international guidelines
- Vaccination with live virus within past 6 months
- Hypersensitivity to hydrocortisone or fludrocortisone or (microsined betamethasone dipropionate\ ) or any of their excipients (spc)
See the full eligibility criteria
- Patient ≥18 years old;
- Admitted to ICU with proven or suspected infection as the main diagnosis;
- Community acquired pneumonia related sepsis or vasopressors dependency (norepinephrine, epinephrine, vasopressin, dopamine, phenylephrine) or septic shock (vasopressor to maintain mean blood pressure of at least 65 mmHg...
- Patients who have been tested for one or more RECORDS specific biomarkers:
- CIRCI
- Endocan
- GILZ
- DUSP-1
- lymphopenia
- Transcriptomic SRS2
- Endotype B
- PCR COVID-19
- PCR Influenza
- PCR other respiratory virus
- Cutaneous vasoconstrictor response to glucocorticoids
- Patient who has signed an informed and written consent whevener he/she is able of consent, if not, if not ascent from his/her representant whenever he/she is present at time of screening for inclusion;
- Patient affiliated to a social security system or to an universal health coverage (Couverture Maladie Universelle (CMU) in France;
- Patient under guardianship or curatorship will be included;
- Patient in case of simple emergency (legal definition) will be included;
- Patients managed with covid 19 and having biological samples available.
- Pregnancy;
- Expected death or withdrawal of life-sustaining treatments within 48 hours;
- Previously enrolled in this study
- Formal indication for corticosteroids according to most recent international guidelines
- Vaccination with live virus within past 6 months
- Hypersensitivity to hydrocortisone or fludrocortisone or (microsined betamethasone dipropionate\ ) or any of their excipients (spc)
- Women of childbearing potential not using contraception
- Nursing women \ For patients included in this stratum, if applicable, do not apply the cream to an infected or ulcerated area
The study team makes the final eligibility decision.
Where it's taking place
- Garches, Hauts-de-Seine, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Garches, Hauts-de-Seine, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.