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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorSecond Affiliated Hospital of Guangzhou Medical University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
From enrollment (Day 1) through Day 30

Secondary outcomes

1

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
2

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
3

success rate of ventilator withdrawal, ICU non ventilator survival time

Time frame
From enrollment (Day 1) through Day 30

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Affiliated Hospital of Guangzhou Medical University

Lead sponsor

Guangzhou Red Cross Hospital

Collaborator

Guangzhou First People's Hospital

Collaborator

Gongguan People's Hospital

Collaborator

Guangzhou Medical University

Collaborator

This trial is not recruiting at the moment. You can still explore other options: