NCT05349383 is a clinical trial of Antibody-Drug Conjugate in Sepsis (SMQ), sponsored by Central South University.

Who is sponsoring NCT05349383?

NCT05349383 is sponsored by Central South University.

What drugs are being tested in NCT05349383?

Interventions in NCT05349383: Antibody-Drug Conjugate, Antineoplastic and immunomodulating agents other than Antibody-Drug Conjugate.

What condition does NCT05349383 study?

NCT05349383 studies Sepsis (SMQ), Opportunistic Infections, Agranulocytosis.

Is NCT05349383 still recruiting?

NCT05349383 is currently completed. Last updated 22 June 2022.

Last reviewed 2022-06-22 · How we verify

NCT05349383

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Evaluation of Reporting of Antibody-Drug Conjugate Associated Sepsis-related Toxicities

Completed Last updated 22 June 2022

What this trial tests

trial testing Antibody-Drug Conjugate in Sepsis (SMQ) in 24,618 participants. Completed in 1 June 2022.

Timeline

22 April 2022

Primary endpoint
22 May 2022

1 June 2022

Quick facts

Lead sponsor	Central South University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	24,618
Start date	22 April 2022
Primary completion	22 May 2022
Estimated completion	1 June 2022
Sites	1 location across China

Drugs / interventions tested

Antibody-Drug Conjugate — full drug profile →
Antineoplastic and immunomodulating agents other than Antibody-Drug Conjugate — full drug profile →

Conditions studied

Sepsis (SMQ) — all drugs for Sepsis (SMQ) →
Opportunistic Infections — all drugs for Opportunistic Infections →
Agranulocytosis — all drugs for Agranulocytosis →

Sponsor

Central South University

Who can join

Eligibility, any sex, with Sepsis (SMQ) or Opportunistic Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Although antibody-drug conjugate(ADC) has proved effective in treating many cancers, few patients receiving ADC may experience rare but life-threatening sepsis-related toxicities such as sepsis and septic shock. Today, data about sepsis/septic shock are scarce. The objective was to investigate reports of sepsis/septic shock adverse events related to ADC, including Gemtuzumab Ozogamicin, Trastuzumab Emtansine, Inotuzumab Ozogamicin, Enfortumab vedotin, Trastuzumab deruxtecan, Sacituzumab govitecan, Brentuximab Vedotin, Moxetumomab pasudotox, Polatuzumab Vedotin, Belantamab Mafodotin, loncastuximab tesirine and Tisotumab vedotin using international pharmacovigilance databases such as the FDA Adverse Event Reporting System (FAERS).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Do antibody-drug conjugates increase the risk of sepsis in cancer patients? A pharmacovigilance study.
Xia S, Zhao YC, Guo L, Gong H, et al · · 2022 · cited 13× · PMID 36467034 · DOI 10.3389/fphar.2022.967017
Immunotherapy in the context of sepsis-induced immunological dysregulation.
Wu Y, Wang L, Li Y, Cao Y, et al · · 2024 · cited 11× · PMID 38835773 · DOI 10.3389/fimmu.2024.1391395

Verify or expand the search:

Other trials of Antibody-Drug Conjugate

Trials testing the same drug.

NCT07051850 — Quality of Life and Treatment Outcomes in RRMM Patients Receiving Advanced vs. Conventional Immunotherapies · recruiting

Other Central South University trials

Trials by the same sponsor.

NCT07444463 — Brain Network Mechanisms of Cognitive Impairments in Major Psychiatric Disorders and Their Clinical Applications · NA · not yet recruiting
NCT07446478 — TIS for Improving Cognitive Impairment Associated With Schizophrenia · NA · not yet recruiting
NCT07045142 — Metformin Alleviates Abnormal Glucose Metabolism Induced by Statins in Schizophrenia Patients · Phase 3 · recruiting
NCT07066813 — Staging Strategies and Their Association With Prognosis and Therapy in Lung Cancer With Cystic Airspaces · recruiting
NCT07063901 — Multimodal Deep Learning for Predicting Treatment Response to Neoadjuvant Chemoimmunotherapy in Esophageal Cancer · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05349383 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Central South University
Last refreshed: 22 June 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05349383.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing