Health Condition 1: B96- Other bacterial agents as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Thymosin Alpha 1: patients will be administered 2 subcutaneous injections of 1.6 mg Tα1 with SOC.from Day 1 to Day 7/ as per investigatorâ??s discretion.
Each vial contains : Thymosin
Sponsors
Gufic Biosciences Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male/female of >= 18 years of age at the time of consent 2. Patient / Legally Acceptable Representative who can and willing to provide Informed Consent 3. Patient diagnosed with sepsis according to the sepsis diagnosis criteria of "Surviving Sepsis Campaign: International Guidelines for Management of Sepsis 3 and Septic Shock: 2016" 4. Patient with total SOFA scores >=2 (Reports within last 24 hours to be considered for screening. In case of multiple reports, latest one should be considered.) 5. Patient with confirmed or suspected infection and satisfy at least one of the following: a. Pathogenic microbes grow in blood and at aseptic locations b. Presence of abscess or partially infected tissues c. Suspected infection identified by at least one of the following evidence Leukocytes at normal aseptic locations - Organic perforation (confirmed by imaging evidence, examination result or intestinal content leak during drainage) - Imaging evidence of pneumonia accompanied by purulent secretion - Related syndromes with high infection risk (cholangitis for example) 6. Patient/ patientâ??s LAR understands and is willing to participate in the clinical study and can comply with clinical trial protocol requirements
Exclusion criteria
Exclusion criteria: 1.Patient Ë? 18 years of age 2. Patient in need for immediate surgery 3. Patient with history of organ or bone marrow transplantation 4. Patient not expected to survive 28 days given their preexisting uncorrectable medical condition 5. Female patient who is breast-feeding or pregnant 6. Patient who has participated in another trial with an investigational drug within 1 month prior to this trial. 7. Patients who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Sequential Organ Failure Assessment (SOFA) scoreTimepoint: from Screening/ Baseline (Day 1) and End of treatment ( Day 7) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Neutrophil-lymphocyte (NLR) ratioTimepoint: Screening/ Baseline (Day 1) and End of treatment ( Day 7);Change in serum lactate levels only in suspected patients with septic shock.Timepoint: Screening/ Baseline (Day 1) and End of Treatment (Day 7);Change in Tumour Necrosis Factor (TNF) levelsTimepoint: Screening/ Baseline (Day 1) and End of treatment ( Day 7);Clearance rate of pathogenic microorganism over a period of 7-daysTimepoint: from Screening/ Baseline (Day 1) and End of treatment ( Day 7);Continuous Renal Replacement Therapy (CRRT) free daysTimepoint: Time frame 28 days;Duration of hospitalizationTimepoint: Day 28;ICU-free daysTimepoint: time frame28 days;Incidence of emerging infection within 7 daysTimepoint: from Screening/ Baseline (Day 1) and End of treatment ( Day 7);Incidences of all-cause hospital mortalityTimepoint: From date of Drug administered until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 28 days];Number of days without antibioticsTimepoint: Time Frame: 28 days;Number of Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse EventTimepoint: Time frame 28 days;Vasoactive agents-free daysTimepoint: Time frame 28 days;Ventilator-free daysTimepoint: time frame 28 days;Change in Absolute Lymphocyte count from Screening/ Baseline (Day 1) and End of TreatmentTimepoint: Screening/ Baseline (Day 1) and End of treatment ( Day 7);Change in C-Reactive Protein (CRP) levelsTimepoint: Screening/ Baseline (Day 1) and End of treatment ( Day 7);Change in CD4/CD8 ratioTimepoint: Screening/ Baseline (Day 1) and End of treatment ( Day 7) | — |
Countries
India
Contacts
Public ContactMr Vairamuthu Ammaiyappan
Gufic Biosciences Limited
Outcome results
None listed