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

April 22, 2025 updated by: Second Affiliated Hospital of Guangzhou Medical University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Severe Pneumonia

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

323

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Lili L Tao
Phone Number: +8613535107553
Email: taollicu@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
30 day mortality rate of critical care patients with severe pneumonia. Time Frame: From enrollment (Day 1) through Day 30	From enrollment (Day 1) through Day 30

Secondary Outcome Measures

Outcome Measure	Time Frame
The incidence rate of herpes simplex virus type 1 infection/reactivation in the lower respiratory tract of critical care patients with severe pneumonia Time Frame: From enrollment (Day 1) through Day 30	From enrollment (Day 1) through Day 30
ICU mortality and in-hospital mortality , ICU stay time and length of in-hospital stay Time Frame: From enrollment (Day 1) through the entire ICU stays and in-hospital stays	From enrollment (Day 1) through the entire ICU stays and in-hospital stays
success rate of ventilator withdrawal, ICU non ventilator survival time Time Frame: From enrollment (Day 1) through Day 30	From enrollment (Day 1) through Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Guangzhou Medical University

Collaborators

Guangzhou First People's Hospital

Guangzhou Red Cross Hospital

The Fourth Affiliated Hospital of Guangzhou Medical University

Gongguan People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

April 14, 2025

First Submitted That Met QC Criteria