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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 100 years
• All sexes
• No healthy volunteers
• Adult, Older adult

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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

About this 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

Conditions

Severe Pneumonia

Being tested

Bronchoalveolar Lavage (BAL) via Fiberoptic Bronchoscopy, throat Swab

Keywords

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

Medical subject headings

Pneumonia, Latent Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Bronchoalveolar Lavage (BAL) via Fiberoptic BronchoscopyDiagnostic 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 SwabDiagnostic 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 30 day mortality rate of critical care patients with severe pneumonia.

   Measured: From enrollment (Day 1) through Day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted20 Apr 2025
2. Study start1 Jun 2025 (estimated)
3. Primary completion1 Jun 2027 (estimated)
4. Study completion1 Oct 2027 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Severe PneumoniaStudies of the same condition, open and under way.
• More trials run by Second Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.