NCT07321275

Brief Summary

Stroke-associated pneumonia (SAP) is a common and serious complication after acute ischaemic stroke (AIS). Existing scores rely mainly on clinical variables, and the added prognostic value of inflammatory markers and early chest CT findings remains uncertain. We developed and externally validated an early multimodal model combining clinical severity, inflammation, and chest CT abnormalities, and explored risk-stratified associations between prophylactic antibiotics and SAP.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,499

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 7, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

January 15, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2026

Completed
Last Updated

March 10, 2026

Status Verified

December 1, 2025

Enrollment Period

1 month

First QC Date

December 19, 2025

Last Update Submit

March 8, 2026

Conditions

Keywords

Acute ischaemic strokeStroke-associated pneumoniaRisk prediction model

Outcome Measures

Primary Outcomes (1)

  • Stroke-associated pneumonia

    SAP was defined as pneumonia occurring within 7 days after stroke onset. Potential events were screened using discharge diagnosis codes and medical record documentation, and then confirmed by manual chart review using prespecified clinical, laboratory, and radiological criteria consistent with the Pneumonia in Stroke Consensus Group and modified CDC definitions.

    within 7 days after stroke onset

Study Arms (2)

Development (Derivation) cohort

External validation cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults (≥18 years) with neuroimaging-confirmed acute ischemic stroke admitted to participating tertiary stroke centers in China. Eligibility requires chest CT performed within 24 h of stroke onset . Patients will be retrospectively identified from electronic medical records and stroke registries, and stroke-associated pneumonia will be assessed within 7 days after stroke onset using prespecified criteria. Only the first eligible admission per individual will be included.

You may qualify if:

  • patients aged ≥18 years;
  • Admitted to a participating stroke centre with neuroimaging-confirmed acute ischaemic stroke ;
  • Had chest CT performed within 24 hours of stroke onset.

You may not qualify if:

  • Pneumonia;
  • Chest CT images unavailable or incomplete for assessment;
  • Insufficient clinical documentation to ascertain stroke-associated pneumonia occurrence within 7 days after stroke onset

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Suzhou Municipal Hospital of Anhui Province

Suzhou, Anhui, 234000, China

Location

Rongcheng County People's Hospital

Baoding, Hebei, China

Location

Ningjin County People's Hospital

Fenghuang, Hebei, 055550, China

Location

The Second Hospital of Hebei Medical University,

Shijiazhuang, Hebei, 050061, China

Location

Central Hospital of Xiangtan

Xiangtan, Hunan, 411100, China

Location

First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Location

Shihezi People's Hospital,

Shihezi, Xinjiang, 836800, China

Location

Xuanwu Hospita

Beijing, China

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurology, Xuanwu Hospital, Capital Medical University

Study Record Dates

First Submitted

December 19, 2025

First Posted

January 7, 2026

Study Start

January 15, 2026

Primary Completion

February 19, 2026

Study Completion

February 19, 2026

Last Updated

March 10, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

Related data will be shared if full study protocol and statistical analysis plan are provided with reasonable design.

Locations