Immune Reconstitution of Immunosuppressed Sepsis Patients
NCT ID: NCT02797431
Last Updated: 2017-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
16 participants
INTERVENTIONAL
2016-01-14
2017-11-13
Brief Summary
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A parallel study will be performed in United State of America to allow a common statistical analysis of the primary end points and analysis for the enrolled patient population.
Detailed Description
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This clinical study will test the ability of IL-7 to restore the absolute lymphocyte counts in septic patients who have markedly reduced levels of circulating lymphocytes. An effect already confirmed in preclinical models of sepsis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CYT107 high frequency
Patients will receive Interleukin-7 (CYT107 liquid solution) at 10µg/kg twice a week for 4 weeks
Interleukin-7
IM administration of CYT107 recombinant glycosylated human IL-7 (SC administration for patients with INR\>2.5 or platelet count \< 35,000
CYT107 low frequency
Patients will receive Interleukin-7 (CYT107 liquid solution) at 10µg/kg twice a week for the first week, followed by CYT107 and Placebo once a week for the three following weeks
Interleukin-7
IM administration of CYT107 recombinant glycosylated human IL-7 (SC administration for patients with INR\>2.5 or platelet count \< 35,000
Placebo
IM administration of Placebo (SC administration for patients with INR\>2.5 or platelet count \< 35,000
Control
Patients will receive Placebo (NaCl 0.9%) twice a week for 4 weeks
Placebo
IM administration of Placebo (SC administration for patients with INR\>2.5 or platelet count \< 35,000
Interventions
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Interleukin-7
IM administration of CYT107 recombinant glycosylated human IL-7 (SC administration for patients with INR\>2.5 or platelet count \< 35,000
Placebo
IM administration of Placebo (SC administration for patients with INR\>2.5 or platelet count \< 35,000
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients with persistent suspected sepsis at 48-120 hrs after admission
3. Two or more criteria for the systemic inflammatory response syndrome (SIRS) (see reference #19 for SIRS criteria) and a clinically or microbiologically suspected infection.
4. At least one organ failure as defined by a SOFA score of ≥2 at any time point during the 48-120 hrs after admission to the ICU
5. Requirement of vasopressor treatment as follows: i) epinephrine or norepinephrine at ≥ 0.05 µg/kg/min ideal body weight; ii) vasopressin, or iii) dopamine at ≥ 4-5 μg/kg/min ideal body weight, continuously for 4 hrs or more, provided that at least 20 ml/kg of ideal body weight of crystalloid or an equivalent volume of colloid was administered during the 24-hour interval surrounding the start of vasopressor treatment, to maintain systolic pressure ≥ 90 mmHg or a mean arterial pressure ≥ 60 mmHg at any time point during their sepsis course preceding enrollment into the IL-7 study.
6. Lymphopenia with an absolute lymphocyte count ≤ 900 cells/mm3 at either the day of consent or the day prior to consent during their ICU stay.
7. Predicted length of stay in the ICU of up to two weeks after starting drug therapy treatment in the trial
8. Ability to obtain a signed informed consent from patient or LAR consent.
Exclusion Criteria
2. Cardiopulmonary resuscitation within the previous 4 weeks without objective evidence of full neurologic recovery) or patients who have minimal chance of survival and are not expected to live \> 3-5 days as defined by an APACHE II score of ≥ 35 at time of consideration for study eligibility
3. Patients with a history of or who currently have evidence of autoimmune disease including for example: myasthenia gravis, Guillain Barre syndrome, systemic lupus erythematosis, multiple sclerosis, scleroderma, ulcerative colitis, Crohn's disease, autoimmune hepatitis, Wegener's etc.
4. Patients who have received solid organ transplant or bone marrow transplant
5. Patients with active or a history of acute or chronic lymphocytic leukemia
6. AIDS-defining illness (category C) diagnosed within the last 12 months prior to study entry
7. History of splenectomy
8. Any hematologic disease associated with hypersplenism, such as thalassemia, hereditary spherocytosis, Gaucher's Disease, and autoimmune hemolytic anemia
9. Pregnant or lactating women
10. Participation in another investigational interventional study within the last 6 months prior to study entry, with the exception of studies aimed at testing sedation products belonging to standard of care such as Propofol, Dexmedetomidine, Midazolam.
11. Patients receiving immunosuppressive drugs, e.g., TNF-alpha inhibitors, for rheumatoid arthritis, inflammatory bowel disease or any other reason, or systemic corticosteroids other than hydrocortisone at a dose of 300 mg/day
12. Patients receiving concurrent immunotherapy or biologic agents including: growth factors, cytokines and interleukins, (other than the study medication); for example IL-2,growth factors, interferons, HIV vaccines, immunosuppressive drugs, hydroxyurea, immunoglobulins, adoptive cell therapy
13. Prisoners
18 Years
80 Years
ALL
No
Sponsors
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Revimmune
INDUSTRY
Vanderbilt University Medical Center
OTHER
University Hospital, Limoges
OTHER
Responsible Party
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Principal Investigators
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Bruno FRANCOIS, DM
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Limoges
Locations
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CHU LIMOGES Service de Réanimation
Limoges, , France
Hospice Civil de Lyon - Hôpital Edouard Herriot - Service de Réanimation Médicale
Lyon, , France
Hopital Lariboisière - Service d'anesthésie-réanimation
Paris, , France
Countries
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References
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Francois B, Jeannet R, Daix T, Walton AH, Shotwell MS, Unsinger J, Monneret G, Rimmele T, Blood T, Morre M, Gregoire A, Mayo GA, Blood J, Durum SK, Sherwood ER, Hotchkiss RS. Interleukin-7 restores lymphocytes in septic shock: the IRIS-7 randomized clinical trial. JCI Insight. 2018 Mar 8;3(5):e98960. doi: 10.1172/jci.insight.98960.
Other Identifiers
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I14037 IRIS-7a
Identifier Type: -
Identifier Source: org_study_id