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: Health Condition 1: B96- Other bacterial agents as the cause of diseases classified elsewhere

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 3 April 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified