Sepsis
Conditions
Keywords
thymosin alpha 1; sepsis; monocyte; pharmacokinetics
Brief summary
The purpose of this study is to determine whether thymosin alpha 1 is effective on improving monocyte function and has the desired pharmacologic activity for sepsis
Detailed description
Part 1: To observe the function of thymosin alpha 1 in sepsis patients via improving phagocytosis, bacteria eradication and antigen-presenting on monocyte Part 2: Pharmacokinetics of thymosin alpha 1 for sepsis
Interventions
DRUGthymosin alpha 1
Subcutaneous injections of 1.6 mg thymosin alpha 1 twice per day for seven days, prior to administration, the lyophilized powder is to be reconstituted with 1 ml of the provided diluent.
OTHERPlacebo
Subcutaneous injections of placebo (saline) twice per day for seven days
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Written informed consent from the patients or their next of kin for patients unable to consent 2. Age ≥18 yrs 3. Presence of sepsis/ septic shock according to sepsis 3.0
Exclusion criteria
1. Pregnant or lactation period. 2. Age \<18 yrs 3. Receiving immunosuppressive therapy such as cyclosporine, azathioprine or cancer chemotherapy within one month. 4. History of bone marrow, lung, liver, kidney, pancreas or small bowel transplantation; 5. Acute pancreatitis with no established source of infection. 6. Not expected to survive 28 days because of end-stage diseases. 7. Participation in another clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ta 1 improving immune function of monocyte for sepsis, used by flow cytometric to measure phagocytosis(CD11b, CD64), antigen presenting(HLA-DR, CD86 and PD-L1), and apoptosis(active caspase 3) on monocyte, | 28days | Phagocytosis was measured by expression of monocyte surface antigen CD64 and CD11b, as well as pHrodo™ BioParticles® Phagocytosis Kits to assessing phagocytic activity on monocyte; antigen presenting was measured by HLA-DR, costimulatory molecule CD86 and inhibitory molecule PD-L1 on monocyte; apoptosis was measured by active caspase 3 on monocyte |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relationship between concentration of Ta 1 and prognosis of sepsis patients, measured by concentration of Ta 1, 28-day all-cause mortality, 28-day clearance rate of pathogenic microorganism, ICU stays and hospital stays | 28 days | Concentration of Ta 1 was measured on day 0, 3 and 7 after injection drug or placebo |
| Maximum observed serum concentration (Cmax) of Ta 1 | 7 days | — |
| Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of Ta 1 | 7 days | — |
| Terminal serum half-life (T-HALF) of Ta 1 | 7 days | — |
| Time of maximum observed serum concentration (Tmax) of Ta 1 | 7 days | — |
Countries
China
Outcome results
None listed