Risk Identification Factors for Pulmonary Function Impairment in AIDS Patients Recovered From Severe Pneumonia

Pneumonia Clinical Trial

Official title:

Study on Risk Identification Factors for Lung Function Impairment in AIDS Patients Recovered From Severe Pneumonia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06137196
• Other study ID #: 202326263
• Status: Recruiting
• Start date: November 1, 2023
• Est. completion date: November 1, 2027

Study information

• Verified date: November 2023
• Source: Guangzhou 8th People's Hospital
• Contact: Linghua Li, PhD
• Phone: +862083710825
• Email: llheliza[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Screening for risk factors related to lung function impairment in patients who have recovered from AIDS with severe pneumonia, to provide clinical evidence for early identification and intervention of lung function damage in this population.

Description:

This is a prospective, single-center, non-randomized, clinical observational cohort study. It involves monitoring lung function at discharge (baseline, 0w), and at the 4th, 8th, 12th, 24th, and 48th weeks in patients recovering from severe pneumonia with AIDS. Basic demographic data, HIV RNA quantification, routine blood tests, blood biochemistry, arterial blood gas results, oxygenation index, immune function (CD3+, CD4+, CD8+ T cell counts), and imaging studies are also collected. Multifactorial logistic regression analysis is used to screen for clinical predictors of lung function decline in patients recovering from severe pneumonia

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 1, 2027
• Est. primary completion date: November 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Confirmed HIV infection;

2. Progression to the AIDS stage: CD4+ count <200 cells/µL and/or occurrence of opportunistic infections associated with AIDS;

3. Age between 18 to 65 years;

4. Meet the diagnostic criteria for severe pneumonia, with reference to the 2021 treatment guidelines for community-acquired pneumonia developed by the American Thoracic Society (ATS) and the Infectious Diseases Society of America (IDSA).

Exclusion Criteria:

1. Concurrent central nervous system lesions, severe liver disease, or cirrhosis;

2. Concurrent AIDS-related or non-related tumors;

3. Women who are pregnant or breastfeeding;

4. Presence of serious underlying diseases such as heart, lung, liver, kidney, etc.;

5. Alcohol abuse or drug use;

6. The researcher believes that the overall condition of the subject affects the evaluation and completion of the trial

Related Conditions & MeSH terms

• AIDS
• Pneumonia

Locations

Country	Name	City	State
China	Guangzhou Eighth People's Hospital, Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou 8th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Obstructive Ventilatory Dysfunction	FEV1(Forced Expiratory Volume in One Second )to FVC (Forced Vital Capacity ) Ratio	12 weeks
Secondary	FEV1	FEV1 decrease of =100 mL	12 weeks