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Not yet recruitingNCT06936683Updated Apr 25, 2025

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

An observational study in Severe Pneumonia, sponsored by Second Affiliated Hospital of Guangzhou Medical University. Not yet recruiting. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-04-25.

Sponsored by Second Affiliated Hospital of Guangzhou Medical University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
323
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Severe Pneumonia

Keywords

  • Severe pneumonia
  • Herpes simplex virus type 1
  • infection/reactivation
  • Prognostic effect
03

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
323 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

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.

05

What researchers measure

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

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT06936683
Lead sponsor
Second Affiliated Hospital of Guangzhou Medical University
Collaborators
Guangzhou Red Cross Hospital, Guangzhou First People's Hospital, Gongguan People's Hospital, The Fourth Affiliated Hospital of Guangzhou Medical University
Responsible party
Sponsor
First posted
Apr 20, 2025
Start date
Jun 1, 2025 (estimated)
Primary completion
Jun 1, 2027 (estimated)
Completion
Oct 1, 2027 (estimated)
Last update
Apr 25, 2025

Study contacts

Lili L Tao
Contact
taollicu@163.com
+8613535107553

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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