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

NCT06936683 | Not Yet Recruiting

• 1 other identifier: MR-44-24-013041
• Study Type: observational
• Target: 323
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Severe Pneumonia

Keywords

Severe pneumonia; Herpes simplex virus type 1; infection/reactivation; Prognostic effect

Outcome Measures

Primary Outcomes (1)

• 30 day mortality rate of critical care patients with severe pneumonia.

  From enrollment (Day 1) through Day 30

Secondary Outcomes (3)

• The incidence rate of herpes simplex virus type 1 infection/reactivation in the lower respiratory tract of critical care patients with severe pneumonia

  From enrollment (Day 1) through Day 30

• ICU mortality and in-hospital mortality , ICU stay time and length of in-hospital stay

  From enrollment (Day 1) through the entire ICU stays and in-hospital stays

• success rate of ventilator withdrawal, ICU non ventilator survival time

  From enrollment (Day 1) through Day 30

Interventions

Bronchoalveolar Lavage (BAL) via Fiberoptic Bronchoscopy DIAGNOSTIC_TEST

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.

throat Swab DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study Population Description ：Patients with age\>18 years old admitted to the ICU who meet the diagnostic criteria for severe pneumonia.

You may qualify if:

• : Age\>18 years old. 2: Clinical diagnosis for severe pneumonia. 3: ICU stay time \>72 hours. 4: A written informed consent form was obtained from the members of the patients' family.

You may not qualify if:

• : severe ventilation dysfunction, and effective respiratory support has not been used; 2: Aortic aneurysm and esophageal varices at risk of rupture; 3: Recent acute coronary syndrome, uncontrolled severe hypertension, and malignant arrhythmia; 4: Irreversible bleeding tendencies, such as severe coagulation dysfunction, massive hemoptysis, or gastrointestinal bleeding; 5: Multiple pulmonary bullae at risk of rupture. 6: Estimated survival time\<24 hours. 7: Included in another interventional clinical study.

Sponsors & Collaborators

• Second Affiliated Hospital of Guangzhou Medical University: lead
• Guangzhou Red Cross Hospital: collaborator
• Guangzhou First People's Hospital: collaborator
• Gongguan People's Hospital: collaborator
• Guangzhou Medical University: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Bronchoalveolar lavage fluid (BALF) is a sterile saline solution collected from the lungs during a procedure called bronchoalveolar lavage. A thin, flexible tube (bronchoscope) is inserted into the airways, and saline is gently instilled into a specific lung segment. The fluid is then suctioned back, carrying cells, proteins, and microorganisms from the alveoli (tiny air sacs). BALF is analyzed to diagnose lung infections (e.g., pneumonia), inflammatory diseases (e.g., sarcoidosis), or cancers. It provides critical information about immune cells, pathogens, and biomarkers in the lower respiratory tract.

MeSH Terms

Conditions

Pneumonia; Latent Infection

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Lili L Tao

CONTACT

+8613535107553; taollicu@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: April 20, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 25, 2025

Record last verified: 2025-04