Radiomics Model for the Diagnosis of Pneumocystis Jirovecii Pneumonia in Non-HIV Patients

NCT05701631 | Unknown

• 1 other identifier: S2023-006-01
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the performance of radiomics in differentiating Pneumocystis jirovecii pneumonia (PCP) from other types of pneumonia and to improve the diagnostic efficacy of non-invasive tests in non-HIV patients.

Conditions

Pneumocystis Jirovecii Pneumonia

Keywords

Computed tomography; Diagnostic tests; Pneumocystis jirovecii pneumonia; Radiomics

Outcome Measures

Primary Outcomes (1)

• the diagnostic performance of radiomic model in the PCP diagnosis

  The included patients were randomized in a 7:3 ratio into training and validation cohorts. Radiomic features were extracted from semi-automatically identified infected areas in computed tomography (CT) scans and used to construct a radiomic model. Then, the area under the curve (AUC) of the receiver operating characteristic (ROC) curves were calculated and used to evaluate the diagnostic performance (accuracy, sensitivity, specialty, positive predictive value, negative predictive value) of the model for PCP diagnosis in both training and validation cohorts.

  6 months

Study Arms (1)

non-HIV patients hospitalized for suspected PCP

non-HIV patients hospitalized for suspected PCP

Diagnostic Test: Radiomic model

Interventions

Radiomic model DIAGNOSTIC_TEST

Radiomic model for PCP diagnosis

non-HIV patients hospitalized for suspected PCP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients admitted to our institute with clinical suspected PCP

You may qualify if:

• aged over eighteen years;
• presence of an underlying disease known to be associated with PCP
• symptoms of lower respiratory tract infection, such as fever, cough or dyspnea
• signs of lung infection on high resolution CT at the on-set of the disease
• received BAL examination within three days after CT scans
• underwent qPCR and IF staining tests on the BAL fluid sample.

You may not qualify if:

• with HIV infection
• taking trimethoprim-sulfamethoxazole for prophylaxis
• undiagnosed by qPCR and IF staining tests

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Related Publications (1)

• Yu H, Yang Z, Wei Y, Shi W, Zhu M, Liu L, Wang M, Wang Y, Zhu Q, Liang Z, Zhao W, Chen LA. Computed tomography-based radiomics improves non-invasive diagnosis of Pneumocystis jirovecii pneumonia in non-HIV patients: a retrospective study. BMC Pulm Med. 2024 Jan 2;24(1):11. doi: 10.1186/s12890-023-02827-4.

  PMID: 38167022 DERIVED

MeSH Terms

Conditions

Pneumonia, Pneumocystis

Condition Hierarchy (Ancestors)

Lung Diseases, Fungal; Mycoses; Bacterial Infections and Mycoses; Infections; Pneumocystis Infections; Respiratory Tract Infections; Pneumonia; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Liang-an Chen

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: January 27, 2023
• Study Start: January 15, 2023
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: January 27, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)