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

NCT ID: NCT06936683

Last Updated: 2025-04-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 323 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2027-10-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 1: 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.

Exclusion Criteria

• 1: 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou Red Cross Hospital

OTHER

Sponsor Role: collaborator

Guangzhou First People's Hospital

OTHER

Sponsor Role: collaborator

Gongguan People's Hospital

UNKNOWN

Sponsor Role: collaborator

Guangzhou Medical University

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Lili L Tao

Role: CONTACT

taollicu@163.com

+8613535107553

Other Identifiers

MR-44-24-013041

Identifier Type: -

Identifier Source: org_study_id