Hôpital Edouard Herriot
Lyon, 69003, France
Location status: Recruiting
Location contact
Fabienne VENET, PhD
CONTACT
Fabienne VENET, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT04067674
Septic syndromes are a major although largely under-recognized health care problem and represent the first cause of mortality in intensive care units (ICU). While it has long been known that sepsis deeply perturbs immune homeostasis by inducing a tremendous systemic inflammatory response, novel findings indicate that sepsis indeed initiates a more complex immune response that varies over time, with the concomitant occurrence of both pro- and anti-inflammatory mechanisms. As a resultant, after a short pro-inflammatory phase, septic patients enter a stage of protracted immunosuppression. This is illustrated in those patients by reactivation of dormant viruses (cytomegalovirus (CMV) or Herpes Simplex Virus (HSV)) or infections due to pathogens, including fungi, which are normally pathogenic solely in immunocompromised hosts. These alterations might be directly responsible for worsening outcome in patients who survived initial resuscitation as nearly all immune functions are deeply compromised. New promising therapeutic strategies are currently emerging from those recent findings such as adjunctive immunostimulation for the most immunosuppressed patients. The prerequisite for immunostimulation administration (Interferon gama (IFNg), Granulocyte Macrophage Colony Stimulating Factor (GM-CSF), interleukin 7 (IL-7)) however relies on clinicians' capacity to identify patients who could benefit the most from these immunoadjuvant therapies, as there is no clinical sign of immune dysfunctions.
In this context, the main objectives of IMMUNOSEPSIS 4 study are:
1. to identify the best biomarkers for sepsis-induced immunosuppression 2. to evaluate ex vivo candidate treatments which could rejuvenate immune functions after septic shock
Interested in participating?
Request Info18 year and older
All sexes
Observational
Lyon, 69003, France
Location status: Recruiting
Fabienne VENET, PhD
CONTACT
Fabienne VENET, PhD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Blood sampling for biomarker measurement
Time frame: at day 3 post septic shock diagnosis
Association between decreased MHC class II expression on monocytes at day 3 post diagnosis and occurrence of secondary ICU-acquired infections
Time frame: 28 days post septic shock diagnosis
Association between decreased MHC class II expression on monocytes at day 3 post diagnosis and occurrence of secondary Intensive Care Unit (ICU)-acquired infections
Time frame: 28 days post septic shock diagnosis
Contact information is provided by the study sponsor or research team.
Fabienne VENET, PhD
CONTACT
Valérie CERRO, CRA
CONTACT
Hospices Civils de Lyon
Other
Evaluation of Immunosuppression in Septic Shock: Biomarkers and Pharmacological Restoration
Acronym: IMMUNOSEPSIS 4
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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