Evaluate the Efficacy and Safety of Thymosin α-1 (Tα1) with comparision of placebo in sepsis patient by using with Standrad of care

Phase 3

Recruiting

• Conditions: Other bacterial agents as the cause of diseases classified elsewhere,

• Registration Number: CTRI/2022/09/045538
• Lead Sponsor: Gufic Biosciences Limited

Brief Summary

Sepsis is a significant heterogeneous clinical syndrome with the characters of high mortality and incidence. It is a life-threatening organ dysfunction caused by host immune response to infection.

IP is Thymosin alpha 1 (Tα1), acting as an immune modulator, exerts great biological influence in activating and restoring the dysregulated immune response for patients with sepsis

Total 120 eligible patients will be enrolled in 1:1 ratio in two treatment arms (60 patients in each arm).

7 days of treatment and follow up on Day 28.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-19
• Last Update Posted: 2023-07-03

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 120

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/ patient’s LAR understands and is willing to participate in the clinical study and can comply with clinical trial protocol requirements.

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.
• Patients who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Sequential Organ Failure Assessment (SOFA) score	from Screening/ Baseline (Day 1) and End of treatment ( Day 7)

Secondary Outcome Measures

Name	Time	Method
Incidence of emerging infection within 7 days	from Screening/ Baseline (Day 1) and End of treatment ( Day 7)
Clearance rate of pathogenic microorganism over a period of 7-days	from Screening/ Baseline (Day 1) and End of treatment ( Day 7)
Duration of hospitalization	Day 28
Ventilator-free days	time frame 28 days
ICU-free days	time frame28 days
Continuous Renal Replacement Therapy (CRRT) free days	Time frame 28 days
Vasoactive agents-free days	Time frame 28 days
Change in Absolute Lymphocyte count from Screening/ Baseline (Day 1) and End of Treatment	Screening/ Baseline (Day 1) and End of treatment ( Day 7)
Change in CD4/CD8 ratio	Screening/ Baseline (Day 1) and End of treatment ( Day 7)
Change in Neutrophil-lymphocyte (NLR) ratio	Screening/ Baseline (Day 1) and End of treatment ( Day 7)
Change in Tumour Necrosis Factor (TNF) levels	Screening/ Baseline (Day 1) and End of treatment ( Day 7)
Change in C-Reactive Protein (CRP) levels	Screening/ Baseline (Day 1) and End of treatment ( Day 7)
Change in serum lactate levels only in suspected patients with septic shock.	Screening/ Baseline (Day 1) and End of Treatment (Day 7)
Number of days without antibiotics	Time Frame: 28 days
Incidences of all-cause hospital mortality	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 Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event	Time frame 28 days

Trial Locations

Locations (10)

Aarvy Hospital; 🇮🇳 Gurgaon, HARYANA, India

Govt. Medical College (GMC); 🇮🇳 Jalgaon, MAHARASHTRA, India

King George Hospital Andhra Medical College; 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

Mahtma Gandhi Memorial Hospital; 🇮🇳 Warangal, TELANGANA, India

Medicover Hospitals; 🇮🇳 Hyderabad, TELANGANA, India

MLB medical college; 🇮🇳 Jhansi, UTTAR PRADESH, India

Orchid Speciality Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Ozone Hospital; 🇮🇳 Hyderabad, TELANGANA, India

Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences; 🇮🇳 Rohtak, HARYANA, India

SN Medical College; 🇮🇳 Agra, UTTAR PRADESH, India

Aarvy Hospital

🇮🇳Gurgaon, HARYANA, India

Dr Shashank Srivastava

Principal investigator

9911008948

dr.shashanksrivastava@gmail.com