Clinical study to assess the effect and safety of study product (Thymosin Alpha-1 and Ulinastatin) in sepsis patients.

Not Applicable

• Conditions: Health Condition 1: A419- Sepsis, unspecified organism

• Registration Number: CTRI/2021/04/032842
• Lead Sponsor: Dr Abdul Ansari

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

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

Inclusion Criteria

1 Male or females of greater than or equal to 18 years of age at the time of consent

2 Patient who can and willing to provide written Informed Consent

3 Patient Diagnosed as a sepsis according to the sepsis diagnosis criteria in Surviving Sepsis Campaign International Guidelines for Management of Sepsis 3 and Septic Shock 2016 Patient with at least one acute severe organ failure related to sepsis and total SOFA scores greater than or equal to 4

4 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 aseptic locations CSF, blood, pleural fluid etc

Organ perforation confirmed by imaging evidence, examination result or intestinal content leak during drainage

Imaging evidence of pneumonia accompanied by purulent secretion and impaired gas exchange

Organ Specific syndromes GI tract Biliary tract Urogenital SSI CNS

Exclusion Criteria

1 Patient less 18 years of age

2 Patient having a medical history of allergy or intolerance to Thymosin alpha-1 (T alpha1) or Ulinastatin

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Change in SOFA score from Screening/ Baseline Visit <br/ ><br>2.Change in CD4/CD8 ratio from Screening/ Baseline VisitTimepoint: 1. Day 1 - 7 <br/ ><br>2. Day 1 - 7

Secondary Outcome Measures

Name	Time	Method
1. Incidence of emerging infection within 28 day from screening. <br/ ><br>2. Clearance rate of pathogenic microorganism. <br/ ><br>3.Duration of hospitalization. <br/ ><br>4.Ventilator-free days. <br/ ><br>5.ICU-free days. <br/ ><br>6.Continuous Renal Replacement Therapy (CRRT) free daysTimepoint: 1. Day 1 - 28. <br/ ><br>2. 28 Days. <br/ ><br>3. 28 days. <br/ ><br>4. 28 days. <br/ ><br>5. 28 days. <br/ ><br>6. 28 days.