Severe SepsisETASSNCT00711620
Efficacy of Thymosin alpha1 for Severe Sepsis
A study testing Thymosin alpha 1 in people with Severe Sepsis, run by Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy of thymosin alpha 1 for treating severe sepsis. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Severe Sepsis
- What is being tested?
- Thymosin alpha 1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 366 participants
- Where
- 1 siteChina
- Study dates
- May 2008to Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe sepsis according to ACCP/CCM criteria
- Patient or legally authorized representative able to provide informed consent
Who cannot join
- Subject is less than 18 years or more than 85 years of age
- If female, the subject is pregnant or nursing
- Subject is receiving immunosuppressive therapy such as cyclosporine, azothioprine,or cancer-related chemotherapy
- Patient not expected to survive 28 days because of uncorrectable medical condition, such as poorly controlled neoplasm or other end-stage disease
- History of bone marrow, lung, liver, pancreas, or small-bowel transplantation
- Acute pancreatitis with no established source of infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter, Randomized, Controlled Study to Evaluate the Efficacy of Thymosin alpha1 in Patients With Severe Sepsis
The purpose of this study is to evaluate the efficacy of thymosin alpha 1 for treating severe sepsis.
Read the detailed description
Severe sepsis is a disease of infectious origin with a high risk of death. Over the past decade, thymosin alpha1 have already provided clinicians with additional weapon in the fight against infectious diseases, but it is unknown whether thymosin alpha1 is effective in treating severe sepsis.
- Conditions
- Severe Sepsis
- Being tested
- Thymosin alpha 1
- Keywords
- sepsis, Immunotherapy, Thymosin
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thymosin alpha 1Drug
Also called Zadaxin
1.6 mg s.c injection twice per day for 5 days, then 1.6 mg s.c injection once per day for 2 days.
| Study group | Role | What they receive |
|---|---|---|
| Thymosin alpha 1+Standard Therapy | Experimental | Patients receive treatment based on SSC guideline with additional thymosin alpha1 Receives: Drug: Thymosin alpha 1 |
| normal saline+standard therapy | Placebo comparator | Patients receive treatment based on SSC guideline with additional normal saline. Receives: Drug: Thymosin alpha 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day Mortality
The prospectively defined primary end point was death from any cause and was assessed 28 days after the start of the infusion.
Measured: 28 days
Secondary outcomes (2)
SOFA score
SOFA score was measured on day0, 3 and 7 after the start of the infusion in both groups.
Measured: 7 days
Immune response to Thymosin alpha 1
HLA-DR expression on CD14+,ratio between CD4+ and CD8+, CRP on day 0, 3, 7 after the start of the infusion in both groups.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2008 (estimated)
- Study startMay 2008
- Primary completionDec 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe SepsisStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 366 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Investigators
- Guan Xiangdong, M.D, Study chair, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00711620
- Sponsor's protocol ID
- 2007015
- Acronym
- ETASS
- Status last verified
- Oct 2009
- First submitted
- 27 Jun 2008
- Last updated
- 14 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wu J, Zhou L, Liu J, Ma G, Kou Q, He Z, Chen J, Ou-Yang B, Chen M, Li Y, Wu X, Gu B, Chen L, Zou Z, Qiang X, Chen Y, Lin A, Zhang G, Guan X. The efficacy of thymosin alpha 1 for severe sepsis (ETASS): a multicenter, single-blind, randomized and controlled trial. Crit Care. 2013 Jan 17;17(1):R8. doi: 10.1186/cc11932.
PubMed 23327199
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Controlled Study to Evaluate the Efficacy of Thymosin alpha1 in Patients With Severe Sepsis
- ClinicalTrials.gov ID
- NCT00711620
- Acronym / sponsor ID
- ETASS / 2007015
- Conditions
- Severe Sepsis
- Keywords
- sepsis, Immunotherapy, Thymosin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 366 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 9 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy of thymosin alpha 1 for treating severe sepsis.
Detailed description
Severe sepsis is a disease of infectious origin with a high risk of death. Over the past decade, thymosin alpha1 have already provided clinicians with additional weapon in the fight against infectious diseases, but it is unknown whether thymosin alpha1 is effective in treating severe sepsis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thymosin alpha 1+Standard Therapy | Experimental | Drug: Thymosin alpha 1Patients receive treatment based on SSC guideline with additional thymosin alpha1 |
| normal saline+standard therapy | Placebo comparator | Drug: Thymosin alpha 1Patients receive treatment based on SSC guideline with additional normal saline. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Severe sepsis according to ACCP/CCM criteria
- Patient or legally authorized representative able to provide informed consent
Key exclusion criteria (6 listed)
- Subject is less than 18 years or more than 85 years of age
- If female, the subject is pregnant or nursing
- Subject is receiving immunosuppressive therapy such as cyclosporine, azothioprine,or cancer-related chemotherapy
- Patient not expected to survive 28 days because of uncorrectable medical condition, such as poorly controlled neoplasm or other end-stage disease
- History of bone marrow, lung, liver, pancreas, or small-bowel transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thymosin alpha 1Also: Zadaxin1.6 mg s.c injection twice per day for 5 days, then 1.6 mg s.c injection once per day for 2 days. | Drug | Thymosin alpha 1+Standard Therapy, normal saline+standard therapy |
Primary outcome
28-day Mortality
Time frame: 28 days
The prospectively defined primary end point was death from any cause and was assessed 28 days after the start of the infusion.
2 secondary outcomes
SOFA score
Time frame: 7 days
Immune response to Thymosin alpha 1
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2011.
- Derived from this study: PubMed 23327199Wu J, Zhou L, Liu J, Ma G, Kou Q, He Z, Chen J, Ou-Yang B, Chen M, Li Y, Wu X, Gu B, Chen L, Zou Z, Qiang X, Chen Y, Lin A, Zhang G, Guan X. The efficacy of thymosin alpha 1 for severe sepsis (ETASS): a multicenter, single-blind, randomized and controlled trial. Crit Care. 2013 Jan 17;17(1):R8. doi: 10.1186/cc11932.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guan Xiangdong, M.D study chair
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thymosin alpha 1 in people with Severe Sepsis, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day Mortality (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00711620, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2011.