Investigator Initiated Study to evaluate the safety and efficacy of Thymosin alpha-1 (T alpha-1)
- Conditions
- Health Condition 1: - Health Condition 2: R652- Severe sepsis
- Registration Number
- CTRI/2021/12/038693
- Lead Sponsor
- Dr Prachee sathe
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Male/females of >= 18 years of age at the time of consent
2. Patient who can and willing to provide written Informed Consent
3. Patient diagnosed with sepsis according to the sepsis diagnosis criteria of Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016
4. Patient with at least one acute severe organ failure related to sepsis, and total SOFA scores >=2
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
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. Female patient who is breast-feeding or pregnant
5. Patient with presence of hematologic malignancies
6. Patient who has received radiotherapy or chemotherapy within the past 30 days
7. Patient who has received immunosuppressive drugs (tripterygium wilfordii, Cell Cept, cyclophosphamide, FK506, etc.) or received continuous treatment with prednisolone >10 mg/day (or the same dose of other hormones) in the past 30 days
8. Patient with underlying end-stage diseases not expected to survive 28 days
9. Patient who has undergone CPR in the 72 hours before signing the informed consent and the neuro-mechanism has not fully recovered (GCS score <= 8)
10. Patient having a medical history of allergy or intolerance to Thymosin α-1 (Tα1)
11. Patient with the source of infection that cannot be contained, for example: infections that cannot be handled during surgical operations and drainage
12. Patient who has participated in another trial with an investigational drug within 1 month prior to this trial.
13. 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
- Secondary Outcome Measures
Name Time Method