{"id":753,"date":"2026-09-01T16:45:45","date_gmt":"2026-09-01T16:45:45","guid":{"rendered":"https:\/\/nhdbio.com\/resources\/thymosin-alpha-1-tests-phase-3-sepsis-trial-2025\/"},"modified":"2026-09-01T16:45:45","modified_gmt":"2026-09-01T16:45:45","slug":"thymosin-alpha-1-tests-phase-3-sepsis-trial-2025","status":"publish","type":"post","link":"https:\/\/nhdbio.com\/de\/thymosin-alpha-1-tests-phase-3-sepsis-trial-2025\/","title":{"rendered":"Thymosin Alpha-1 bei Sepsis: Das Ergebnis der 2025 TESTS Phase 3"},"content":{"rendered":"

Die 2025 TESTS-Studie ist aussagekr\u00e4ftiger als fr\u00fchere Berichte \u00fcber kleine Sepsis: 1,106-Erwachsene wurden randomisiert auf verschiedene 22-Zentren verteilt, und Thymosin alpha-1 reduzierte die 28-Tages-Gesamtmortalit\u00e4t nicht.<\/p>

Beweise auf einen Blick<\/h2>
  • Die Studie umfasste randomisiert 1,106-Erwachsene; 1,089 wurden in die modifizierte Intention-to-Treat-Analyse einbezogen.<\/li>
  • Die 28-Tage-Mortalit\u00e4t betrug 23.4% unter Thymosin alpha-1 und 24.1% unter Placebo.<\/li>
  • Das Gef\u00e4hrdungsverh\u00e4ltnis betrug 0.99 (95% CI 0.77\u20131.27; P=0.93), und kein sekund\u00e4rer oder sicherheitsrelevanter Endpunkt unterschied sich signifikant.<\/li><\/ul><\/div><\/div>
    \"Datenvisualisierung
    Originale redaktionelle Forschungsillustration. Es handelt sich nicht um eine Studienfigur, ein Patientenbild, ein Produktfoto, ein geliefertes Testergebnis oder eine Darstellung einer Katalogcharge.<\/figcaption><\/figure>

    Studienprotokoll<\/h2>

    Der prim\u00e4re Endpunkt war der Tod jeglicher Ursache innerhalb von 28 Tagen. Die Hazard Ratio von nahezu eins und das Konfidenzintervall, das eins \u00fcberschreitet, liefern keinen eindeutigen Beweis f\u00fcr eine Verringerung der Mortalit\u00e4t in der gesamten Versuchspopulation.<\/p>

    Design<\/strong>Multizentrische, doppelblinde, randomisierte, placebokontrollierte Phase 3<\/span><\/div>
    Websites<\/strong>22-Zentren in China<\/span><\/div>
    Ge\u00e4ndert ITT<\/strong>542 Thymosin alpha-1; 547 Placebo<\/span><\/div>
    28-Tagesmortalit\u00e4t<\/strong>23.4% versus 24.1%<\/span><\/div>
    Effektsch\u00e4tzung<\/strong>HR 0.99; 95% CI 0.77\u20131.27; P=0.93<\/span><\/div><\/div><\/div>

    Ergebnisse im Kontext<\/h2>

    Vorab festgelegte Untergruppeninteraktionen nach Alter und Diabetes f\u00fchrten zu m\u00f6glichen Differenzsignalen. Untergruppen sind f\u00fcr die Gestaltung zuk\u00fcnftiger Studien n\u00fctzlich, sie machen jedoch kein neutrales Prim\u00e4rergebnis r\u00fcckg\u00e4ngig und sollten nicht als etablierte Indikationen beworben werden.<\/p>

    In einer 2025-Metaanalyse wurden randomisierte 11-Studien mit 1,927-Teilnehmern zusammengefasst und ein Gesamt-Odds-Ratio von 0.73 ermittelt. Die hochwertigen und multizentrischen Teilmengen waren jedoch statistisch nicht signifikant, und die versuchssequenzielle Analyse beurteilte die verf\u00fcgbare Stichprobe als unzureichend. Das gro\u00dfe TESTS-Ergebnis geh\u00f6rt daher in den Mittelpunkt jeder aktuellen Zusammenfassung.<\/p>

    Was die Beweise nicht belegen k\u00f6nnen<\/h2>

    Eine einzelne nationale Studie repr\u00e4sentiert m\u00f6glicherweise nicht jedes Gesundheitssystem oder jeden Sepsis-Ph\u00e4notyp.<\/p>

    Subgruppeneffekte bed\u00fcrfen einer Best\u00e4tigung und sollten hypothesengenerierend bleiben.<\/p>

    Eine klinische Studie einer abgeschlossenen Intervention validiert nicht ein unabh\u00e4ngiges Forschungslos.<\/p>","protected":false},"excerpt":{"rendered":"

    Die 2025 TESTS-Studie ist aussagekr\u00e4ftiger als fr\u00fchere Berichte \u00fcber kleine Sepsis: 1,106-Erwachsene wurden randomisiert auf verschiedene 22-Zentren verteilt, und Thymosin alpha-1 reduzierte die 28-Tages-Gesamtmortalit\u00e4t nicht.<\/p>","protected":false},"author":1,"featured_media":737,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"pim_family_ids":"369","pim_article_type":"Published evidence review","pim_evidence_level":"Large multicenter randomized phase 3 human trial with a neutral primary outcome","pim_reviewer":"Site evidence editorial team","pim_reviewed_date":"2026-09-02","pim_editorial_note":"Source-checked on 2026-09-02. Null results, study size, model\/population limits and relevant conflicts are retained. 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