Clinical Research Directory

AI-Driven Accurate Diagnosis of Pathogens in Severe Pneumonia

Severe pneumonia (SP) is a critical illness characterized by complex etiology, rapid progression, and high mortality. Its precision diagnosis and treatment face two core challenges. First, traditional etiological diagnostic methods (such as culture, serology, PCR) suffer from low detection rates, long turnaround times, and limited pathogen spectrum coverage, making it difficult to meet the clinical need for early, rapid, and precise diagnosis. Even with the application of next-generation sequencing, challenges remain in result interpretation and distinguishing colonization, contamination, and true infection. Second, host immune responses are highly heterogeneous, and there is currently a lack of a subtyping system that can systematically reveal its dynamic evolution and guide precise immunomodulatory therapy. Research on viral severe pneumonia (VSP) indicates that patients exhibit a complex immune imbalance characterized by coexisting hyperactivation of innate immune cells and exhaustion/suppression of adaptive immune cells. Furthermore, this immune heterogeneity may transcend the traditional binary framework, with at least three potential immune subtypes showing significant differences in mortality rates. Therefore, the investigators propose that: By constructing a severe pneumonia cohort and developing an artificial intelligence model that integrates multimodal clinical data (clinical, imaging, microbiological), host multidimensional etiological data (e.g., metagenomic sequencing), and immunomics data (T/B cell immune repertoire, transcriptomics, etc.), it can, on one hand, achieve more accurate and faster etiological diagnosis of severe pneumonia compared to traditional methods; on the other hand, it can identify immune endotypes with distinct immune features, different clinical outcomes, and varied responses to immunomodulatory therapies (e.g., targeting hyperinflammatory or immunosuppressed subtypes). Ultimately, this integrated model system is expected to provide a scientific tool for the individualized treatment and clinical decision-making in severe pneumonia, guiding precise immune intervention to improve patient prognosis.

Rapid Identification of Infectious Pathogens in Severe Pneumonia Guided by Bronchoscopic Imaging and Lung CT

Severe pneumonia requires rapid and accurate diagnosis for targeted treatment, but single lung CT has limitations in identifying pathogens and distinguishing infectious/non-infectious etiologies. This is a retrospective self-controlled study enrolling patients diagnosed with severe pneumonia at the institution between 2024 and 2025 (recruitment will be extended 6-12 months if fewer than 400 patients are enrolled), all of whom underwent both single lung CT and bronchoscopy-combined CT examinations. Clinical data will be collected retrospectively, including demographic information, bronchoscopic mucosal findings (e.g., congestion, exudation), lung CT lesion characteristics (e.g., consolidation, ground-glass opacity), and gold standard diagnostic results (pathogenic detection or clinical comprehensive diagnosis). The core objective is to compare the diagnostic precision between single lung CT and bronchoscopy-combined CT, focusing on accuracy, sensitivity, and specificity across three etiological subtypes (bacterial/fungal, viral, non-infectious). Bronchoscopy complements CT by directly visualizing airway mucosal changes, while CT provides panoramic views of pulmonary lesions. Their combination is hypothesized to improve diagnostic accuracy. The findings aim to optimize diagnostic strategies for severe pneumonia, guiding clinicians to select more effective imaging approaches.

Diagnostic Application of AI-ROSE in Severe Pneumonia

AI-ROSE is an innovative immunofluorescence staining combined with artificial intelligence image analysis technology that uses a fully automated fluorescence microscope to image pathogens in real time. AI algorithms automatically identify pathogen types (such as bacteria, fungi, etc.) and cellular backgrounds, quickly interpret results, and automatically issue color graphic reports for clinical doctors to take earlier and more accurate targeted treatment for critically ill patients. This study used bronchoalveolar lavage fluid as a biological sample and compared it with traditional examination methods to analyze the diagnostic accuracy and clinical practicality of AI-ROSE in patients with severe pneumonia.

Microbiome and Host Susceptibility in Severe Pneumonia, a Prospective, Multicenter, Cohort Study

This study was a prospective multicenter cohort of severe pneumonia. And by collecting clinical samples to clarify the correlation between lung microbiome, intestinal microbiome, host susceptibility, and prognosis of severe pneumonia patients.

Herpes Simplex Virus Type 1 Infection/Reactivation of Patients With Severe Pneumonia（the HSV-SP Study）

Severe pneumonia(SP) is a one of the main causes of death for critically ill patients.Samples of bronchoalveolar lavage fluid (BALF) from SP patients often report positive for herpes simplex virus type 1 (HSV-1) DNA. However, to date, it is unclear the impact and significance of this positive result on SP patients. This study will evaluate the prognostic impact of lower respiratory tract HSV-1 infection/reactivation on ICU severe pneumonia patients.At the same time, by analyzing the risk factors that affect prognosis, we will identify populations with the potential for intervention benefits and provide a basis for further intervention treatment.

Species-specific Bacterial Detector for Fast Pathogen Diagnosis of Severe Pneumonia

This study is a multicenter randomized controlled trial. The purpose of this study is to assess the efficacy of Species-specific Bacterial Dector（SSBD）for fast pathogen diagnosis and treatment in patients with severe pneumonia. Several adult ICU units from the hospitals in Jiangsu province participate the study and the hosted unit is the Department of Critical Care Medicine, Affiliated Drum Tower Hospital of Nanjing University Medical College. All patients who met the inclusion criteria are enrolled and randomly assigned either to the experiment group or to the control group, and received empiral antibiotics initially. In the experiment group, secretions from low respiratory tract are detected by SSBD and conventional culture tests simultaneously on day1,day3 and day7 after enrollment, while in the control group conventional culture tests are carried out on the same days. In the experiment group, antibiotics adjustments are made by two experienced doctors immediately when SSBD results are available, and other treatments are equivalent to those in the control group as routinely. Some clinical parameters and outcomes are recorded.

Enhancing Pediatric Acute Care Through Adaptive E-Learning and In-Person Skills Practice in Tanzania

The goal of this clinical trial is to evaluate whether the integration of in-person skills practice (ISP) with an adaptive e-learning platform can improve refresher learning progress (RLP) among healthcare providers in pediatric care settings in Tanzania. The main questions it aims to answer are: Can healthcare providers who participate in ISP sessions facilitated by clinical champions achieve greater improvements in refresher learning progress (RLP)? Will providers in the intervention group demonstrate improved metacognition and practical skill performance compared to those in the control group? Researchers will compare healthcare providers using the ISP digital platform (Rhapsode Capable™) to providers using paper-based ISP to see if the digital platform results in significantly higher RLP and fewer skill-based errors. Participants will: Complete adaptive e-learning modules focused on pediatric care topics (e.g., newborn resuscitation, severe malnutrition). Participate in ISP sessions where clinical champions provide feedback and assess performance.

Dynamic Pattern of Etiology, Immunoinflammatory Factors and Their Association With Prognosis of Severe Pneumonia

The goal of this longitudinal observational study is to investigate the pathogen spectrum composition of severe pneumonia (SP) in different disease stages and to study the changes of immune inflammatory factors in patients with SP in different course of disease during and after the COVID-19 pandemic. The main questions it aims to answer is: What is the pathogenic profile of SP patient admitted in intensive care unit (ICU) during and after COVID-19 pandemic? What is the dynamic pattern of etiology and immunoinflammatory factors of SP progression during the period in ICU? Are those indexes mentioned above associated with the prognosis of SP?

Rapid Diagnosis of Severe Respiratory Tract Infectious Diseases and Screening of Biomarkers for Stratified Diagnosis

The purpose of this study is to clarify the biomarkers for rapid diagnosis and stratified diagnosis of severe respiratory tract infectious diseases through clinical experiments.

Fulminant Severe CAP - an Observational Study

Severe community-acquired pneumonia (CAP) represents a major cause of hospital mortality. Among severe CAP cases, some exhibit a rapidly progressive evolution, leading to severe ARDS/acute respiratory failure and septic shock within hours to a few days. This type of pneumonia, known as "fulminant pneumonia," is characterized by its rapid onset and deterioration, often necessitating immediate medical intervention. Despite its severity, the true incidence and optimal treatment for fulminant pneumonia are not well understood. This knowledge gap is due to the lack of attention towards pneumonia as a potential time-dependent illness and the separation of overlapping clinical topics: severe pneumonia, ARDS, and sepsis. In clinical practice, pneumonia is the most frequent cause of both ARDS and sepsis. However, these conditions are often considered separately, combining ARDS and sepsis from various extra-pulmonary causes with those originating from pneumonia. The COVID-19 pandemic, with its vast number of severe CAP cases in a short period, has highlighted the existence of fulminant pneumonias, underscoring the need for further investigation. Recent randomized clinical trials (RCTs) and experiences from COVID-19 have suggested that early and prolonged corticosteroid administration can reduce mortality in patients with severe SARS-CoV-2 infection and severe CAP/ARDS of bacterial origin. The aim of this observational study is to analyze the rate of fulminant pneumonia and assess the impact of early corticosteroid treatment in a multicentric population of hospitalized patients with severe pneumonia.

The Application of Different Sedation Protocols in ICU Patients With Severe Pneumonia

This study collected data from 600 patients with severe pneumonia to compare the duration of mechanical ventilation under different sedation regimens in real-world settings. It also evaluated and compared the sedation success rates, hemodynamic changes, and clinical outcomes of patients with severe pneumonia.

Detection and Characterization of Lower Respiratory Infections in Critically Ill Patients

This study is a prospective observation study for lower respiratory tract infections in medical intensive care unit. Microbiologic and clinical characteristics and outcomes of patients with severe pneumonia in medical intensive care unit will be monitored and analyzed.