Evidence map›Paper›PMID 23327199›Full record

Trial reportCritical care (London, England)2013

The efficacy of thymosin alpha 1 for severe sepsis (ETASS): a multicenter, single-blind, randomized and controlled trial.

Jianfeng Wu, Lixin Zhou, Jiyun Liu, Gang Ma, Qiuye Kou, Zhijie He, Juan Chen, Bin Ou-Yang, Minying Chen, Yinan Li and 9 more

6 registry-linked trialsOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Critical care (London, England), 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 6 registered trials, which are not on this map. Cited by 72 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
72citing papers in PubMed, 6 pooled it
5.1field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00711620 nacompletednot on this map

Multicenter, Randomized, Controlled Study to Evaluate the Efficacy of Thymosin alpha1 in Patients With Severe Sepsis

TypeinterventionalSponsorSun Yat-sen UniversityRan2008 to 2011Enrolled366ConditionsSevere SepsisArmsThymosin alpha 1
NCT02867267 phase3completednot on this mapstarted 2016, after this paper: background citation

The Efficacy and Safety of Thymosin Alpha 1 for Sepsis: a Multicenter , Double-Blinded, Randomized and Controlled Clinical Trial

TypeinterventionalSponsorSun Yat-sen UniversityRan2016 to 2021Enrolled1,106ConditionsSepsisArmsThymosin alpha 1, Placebo
NCT03659578 phase2completednot on this mapstarted 2018, after this paper: background citation

A Phase II Study of Thymopeptide a1 During Split-course Chemoradiotherapy to Reduce Acute Pneumonia For Bulky None-small Cell Lung Cancer

TypeinterventionalSponsorSun Yat-sen UniversityRan2018 to 2021Enrolled69ConditionsNon-small Cell Lung CancerArmsConcurrent chemotherapy, split-course radiotherapy, thymosin alpha 1
NCT04903405 unknown statusnot on this mapstarted 2021, after this paper: background citation

Immune Function Monitoring and Immunotherapy in Sepsis: a Cross-sectional Survey in China

Typeobservational_patient_registrySponsorSun Yat-sen UniversityRan2021 to 2021Enrolled5,000ConditionsSepsis, Septic ShockArmsNo intervention
NCT06139419 phase2completednot on this mapstarted 2023, after this paper: background citation

A Prospective Phase II Controlled Study to Evaluate the Impact of Thymosin Alpha 1 on the Completion Rate of Consolidation Immunotherapy After Radical Radiochemotherapy for Locally Advanced Non-Small Cell Lung Cancer

TypeinterventionalSponsorSun Yat-sen UniversityRan2023 to 2026Enrolled114ConditionsNon-small Cell Lung CancerArmsdefinitive radiotherapy, induction chemo-immunotherapy, concurrent chemotherapy, Immunotheapy consolidation, Thymosin Alpha1
NCT06178146 phase4unknown statusnot on this mapstarted 2023, after this paper: background citation

A Prospective, Open, Randomized Controlled Stage II Trial Investigating the Efficacy and Safety of Thymosin Alpha-1 in Treating Moderate to Severe Immune-related Adverse Events

TypeinterventionalSponsorJun WangRan2023 to 2025Enrolled40ConditionsIrAEArmsThymosin Alpha1, Immunosuppressant
3 · Its place in the literature

Who cites it

72 citing papers in PubMed, 6 syntheses or guidelines pooled it, 116 citations in OpenAlex.

  1. Pooled it
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  11. Immunology of Sepsis.Clinics in chest medicine · 2026
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12 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 6 institutions in 1 country.

Jianfeng Wu
Lixin Zhou
Jiyun Liu
Gang Ma
Qiuye Kou
Zhijie He
Juan Chen
Bin Ou-Yang
Minying Chen
Yinan Li
Xiaoqin Wu
Baochun Gu
Lei Chen
Zijun Zou
Xinhua Qiang
Yuanyuan Chen
Aihua Lin
Guanrong Zhang
Xiangdong Guan
Sun Yat-sen University · CNFirst People's Hospital of Foshan · CNGuangzhou Medical University · CNSun Yat-sen University Cancer Center · CNSun Yat-sen Memorial Hospital · CNThe First Affiliated Hospital, Sun Yat-sen University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionSevere sepsis is associated with a high mortality rate despite implementation of guideline recommendations. Adjunctive treatment may be efficient and require further investigation. In light of the crucial role of immunologic derangement in severe sepsis, thymosin alpha 1 (Tα1) is considered as a promising beneficial immunomodulatory drug. The trial is to evaluate whether Tα1 improves 28-day all-cause mortality rates and immunofunction in patients with severe sepsis.

methodsWe performed a multicenter randomized controlled trial in six tertiary, teaching hospitals in China between May 12, 2008 and Dec 22, 2010. Eligible patients admitted in ICU with severe sepsis were randomly allocated by a central randomization center to the control group or Tα1 group (1:1 ratio). The primary outcome was death from any cause and was assessed 28 days after enrollment. Secondary outcomes included dynamic changes of Sequential Organ Failure Assessment (SOFA) and monocyte human leukocyte antigen-DR (mHLA-DR) on day 0, 3, 7 in both groups. All analyses were done on an intention-to-treat basis.

resultsA total of 361 patients were allocated to either the control group (n = 180) or Tα1 (n = 181) group. The mortalities from any cause within 28 days in the Tα1 group and control group were 26.0% and 35.0% respectively with a marginal P value (nonstratified analysis, P = 0.062; log rank, P = 0.049); the relative risk of death in the Tα1 group as compared to the control group was 0.74 (95% CI 0.54 to 1.02). Greater improvement of mHLA-DR was observed in the Tα1 group on day 3 (mean difference in mHLA-DR changes between the two groups was 3.9%, 95% CI 0.2 to 7.6%, P = 0.037) and day 7 (mean difference in mHLA-DR changes between the two groups was 5.8%, 95% CI 1.0 to 10.5%, P = 0.017) than in the control group. No serious drug-related adverse event was recorded.

conclusionsThe use of Tα1 therapy in combination with conventional medical therapies may be effective in improving clinical outcomes in a targeted population of severe sepsis.

trial registrationClinicalTrials.gov NCT00711620.

Indexed as

Adjuvants, ImmunologicAgedAged, 80 and overFemaleHumansInjections, SubcutaneousMaleMiddle AgedProspective StudiesSepsisSingle-Blind MethodSurvival RateThymalfasinThymosinTreatment OutcomeAdjuvants, ImmunologicThymalfasinThymosin

Identifiers

PMID23327199
PMCPMC4056079
OpenAlexW2101071695

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.