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NCT Number: NCT06936683

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

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bronchoalveolar Lavage (BAL) via Fiberoptic Bronchoscopy

Diagnostic Test

Bronchoalveolar Lavage (BAL) via Fiberoptic Bronchoscopy

  • 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.
  • 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).
  • 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%.
  • 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:

  • Positioning the patient with their head tilted slightly backward;
  • Using a sterile, synthetic-fiber swab with a plastic shaft (avoiding calcium alginate or wooden shafts);
  • Vigorously rubbing the swab over both tonsillar pillars and the posterior pharyngeal wall while avoiding contact with the tongue, teeth, or uvula;
  • Immediately placing the swab into appropriate transport media viral/bacterial);
  • Maintaining cold chain (2-8°C) for specimen transport if required.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Lili L Tao

CONTACT

[email protected]

+8613535107553

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Guangzhou Medical University

Other

Collaborators

  • Gongguan People's Hospital
  • Guangzhou First People's Hospital
  • Guangzhou Medical University
  • Guangzhou Red Cross Hospital

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 20, 2025
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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