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Immunocompromised Host Pneumonia in ICU Settings: Phenotypic Profiling-Guided Anti-Infective Protocol Development - A Prospective Study

Immunocompromised Host Pneumonia in ICU Settings: Phenotypic Profiling-Guided Anti-Infective Protocol Development - A Prospective Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108207
Enrollment
Unknown
Registered
2025-08-26
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immunocompromised-host Pneumonia

Interventions

Precision-guided group:Treatment is administered according to the precision-guided antimicrobial strategy model based on Phase I phenotypes.
Empirical group:Antimicrobial therapy guided by the clinician's expertise in patient management

Sponsors

The First Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Phase I Inclusion Criteria: Inclusion of a proportion of samples based on admission diagnoses and medical history fields: a. Patients with explicit admission diagnoses in the database, such as: "immunocompromised," "immunodeficiency," "pneumonia," "pulmonary infection," etc. b. Patients meeting pneumonia-related diagnoses (e.g., pneumonia, pulmonary infection, community-acquired pneumonia, hospital-acquired pneumonia, severe pneumonia) AND having documented histories of: Malignancy Chemotherapy use Post-solid organ transplantation Post-hematopoietic stem cell transplantation Rheumatic/autoimmune diseases under treatment HIV infection Corticosteroid therapy Immunosuppressant use Chronic kidney disease Type 2 diabetes mellitus; 2. Inclusion of a proportion of samples based on post-admission diagnostic findings: Patients with confirmed pneumonia (supported by imaging evidence) AND meeting laboratory diagnostic criteria for immunosuppression. 3. Integration of samples from criteria 1 and 2. 4.Phase II Inclusion Criteria: Patients admitted to the Intensive Care Unit (ICU) of the First Affiliated Hospital of Xi’an Jiaotong University during the 3-month period starting from Phase II initiation, meeting both of the following: Confirmed pneumonia-related diagnosis (supported by symptoms, clinical signs, disease course, and/or imaging evidence). Immunocompromised status, defined as meeting: Laboratory diagnostic criteria for immunosuppression AND/OR At least one of the following: a) Active malignancy; b) Current cancer chemotherapy; c) Post-solid organ transplantation (SOT); d) Hematopoietic stem cell transplantation (HSCT); e) HIV/AIDS (CD4+ T-cell count = 200 mg/day for >14 consecutive days, or cumulative dose >600 mg); g) Treatment with biological agents; h) Use of disease-modifying antirheumatic drugs (DMARDs) or immunosuppressants. 5.For community-acquired pneumonia cases: CURB-65 score >= 3.

Exclusion criteria

Exclusion criteria: 1.Phase I exclusion criteria:? Patients aged = 1 critical clinical data items: Chest imaging not completed within 48 hours post-admission; Initial laboratory screening not completed within 24 hours post-enrollment; 13. Protocol violations, non-compliance, loss to follow-up, or investigator-determined exclusion during the study.

Design outcomes

Primary

MeasureTime frame
Precision Anti-Infective Treatment Strategies: A Comparative Analysis of Divergence and Consistency;Pathogen detection concordance rate;

Secondary

MeasureTime frame
In-hospital/28-day/90-day/180-day all-cause mortality rate?ICU length of stay;

Countries

China

Contacts

Public ContactQin-Dong Shi

The First Affiliated Hospital of Xi'an Jiaotong University

shiqindong@163.com+86 29 8532 3215

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026