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NCT06936683

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

Sponsor: Second Affiliated Hospital of Guangzhou Medical University

View on ClinicalTrials.gov

Summary

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.

Official title: Prognostic Effect of Herpes Simplex Virus Type 1 Infection/Reactivation in the Lower Respiratory Tract of Critical Care Patients With Severe Pneumonia(the HSV-SP Study): a Study Protocol for a Multicenter, Prospective Cohort Study

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

OBSERVATIONAL

Enrollment

323

Start Date

2025-06-01

Completion Date

2027-10-01

Last Updated

2025-04-25

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Bronchoalveolar Lavage (BAL) via Fiberoptic Bronchoscopy

Bronchoalveolar Lavage (BAL) via Fiberoptic Bronchoscopy 1. Site selection: For patients with limited lesions, the lesion segment was chosen; For patients with diffuse lesions, the right middle lobe or left upper lobe tongue should be severed. 2. Injecting physiological saline: After the top of the bronchoscope is embedded in the target bronchial segment or subsegment opening, 37 ℃ or room temperature physiological saline is rapidly injected through the operating channel, with a total volume of 60-120ml, injected in batches (20-50ml each time). 3. Negative pressure suction: After injecting physiological saline, immediately use appropriate negative pressure (generally recommended below 100mmHg) to suction and obtain BALF, with a total recovery rate of ≥ 30%. 4. BALF collection: Specimens used for pathogen analysis need to be collected in sterile containers; Cytological analysis requires the selection of plastic containers or siliconized glass containers to reduce cell adhesion.

DIAGNOSTIC_TEST

throat Swab

A throat swab is a diagnostic sampling technique used to collect microbial specimens from the oropharynx and tonsillar areas. The standardized procedure involves: 1. Positioning the patient with their head tilted slightly backward; 2. Using a sterile, synthetic-fiber swab with a plastic shaft (avoiding calcium alginate or wooden shafts); 3. Vigorously rubbing the swab over both tonsillar pillars and the posterior pharyngeal wall while avoiding contact with the tongue, teeth, or uvula; 4. Immediately placing the swab into appropriate transport media viral/bacterial); 5. Maintaining cold chain (2-8°C) for specimen transport if required.