Clinical trial NCT06936683: Herpes Simplex Virus Type 1 Infection/Reactivation of Patients With Severe Pneumonia（the HSV-SP Study）
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Severe Pneumonia
Keywords: Severe pneumonia
Herpes simplex virus type 1
infection/reactivation
Prognostic effect
Lead sponsor: Second Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
Collaborators: name: Guangzhou Red Cross Hospital
name: Guangzhou First People's Hospital
name: Gongguan People's Hospital
name: Guangzhou Medical University
First posted: 2025-04-20
Enrollment: 323
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: 30 day mortality rate of critical care patients with severe pneumonia.
timeFrame: From enrollment (Day 1) through Day 30
Secondary outcomes:
measure: The incidence rate of herpes simplex virus type 1 infection/reactivation in the lower respiratory tract of critical care patients with severe pneumonia
timeFrame: From enrollment (Day 1) through Day 30
measure: ICU mortality and in-hospital mortality , ICU stay time and length of in-hospital stay
timeFrame: From enrollment (Day 1) through the entire ICU stays and in-hospital stays
measure: success rate of ventilator withdrawal, ICU non ventilator survival time
timeFrame: From enrollment (Day 1) through Day 30
Other outcomes:
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