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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06936683
Enrollment
323
Registered
2025-04-20
Start date
2025-06-01
Completion date
2027-10-01
Last updated
2025-04-25

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

Conditions

Severe Pneumonia

Keywords

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

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.

Interventions

DIAGNOSTIC_TESTBronchoalveolar 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_TESTthroat 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.

Sponsors

Guangzhou Red Cross Hospital
CollaboratorOTHER
Guangzhou First People's Hospital
CollaboratorOTHER
Gongguan People's Hospital
CollaboratorUNKNOWN
Guangzhou Medical University
CollaboratorOTHER
Second Affiliated Hospital of Guangzhou Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
30 day mortality rate of critical care patients with severe pneumonia.From enrollment (Day 1) through Day 30

Secondary

MeasureTime frame
The incidence rate of herpes simplex virus type 1 infection/reactivation in the lower respiratory tract of critical care patients with severe pneumoniaFrom enrollment (Day 1) through Day 30
ICU mortality and in-hospital mortality , ICU stay time and length of in-hospital stayFrom enrollment (Day 1) through the entire ICU stays and in-hospital stays
success rate of ventilator withdrawal, ICU non ventilator survival timeFrom enrollment (Day 1) through Day 30

Contacts

Primary ContactLili L Tao
taollicu@163.com+8613535107553

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026