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

Recruiting

• Conditions: AIDS; Pneumonia

• Registration Number: NCT06137196
• Lead Sponsor: Guangzhou 8th People's Hospital

Brief 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.

Detailed 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

Study Timeline

• Status Verified: 2023-11
• Study Start: 2023-11-01
• Study First Submitted: 2023-11-13
• Study First Submitted QC: 2023-11-13
• Last Update Submitted: 2023-11-13
• Study First Posted: 2023-11-18
• Last Update Posted: 2023-11-18
• Primary Completion: 2026-11-01
• Study Completion: 2027-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Obstructive Ventilatory Dysfunction	12 weeks	FEV1(Forced Expiratory Volume in One Second )to FVC (Forced Vital Capacity ) Ratio

Secondary Outcome Measures

Name	Time	Method
FEV1	12 weeks	FEV1 decrease of ≥100 mL

Trial Locations

Locations (1)

Guangzhou Eighth People's Hospital, Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China