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

Sponsor

Guangzhou 8th People's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06137196

Collaborator

(none)

100

Enrollment

Location

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
AIDS Pneumonia

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 Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2026

Anticipated Study Completion Date :

Nov 1, 2027

Outcome Measures

Primary Outcome Measures

Obstructive Ventilatory Dysfunction [12 weeks]
FEV1(Forced Expiratory Volume in One Second )to FVC (Forced Vital Capacity ) Ratio

Secondary Outcome Measures

FEV1 [12 weeks]
FEV1 decrease of ≥100 mL

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Confirmed HIV infection;
Progression to the AIDS stage: CD4+ count <200 cells/µL and/or occurrence of opportunistic infections associated with AIDS;
Age between 18 to 65 years;
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:

Concurrent central nervous system lesions, severe liver disease, or cirrhosis;
Concurrent AIDS-related or non-related tumors;
Women who are pregnant or breastfeeding;
Presence of serious underlying diseases such as heart, lung, liver, kidney, etc.;
Alcohol abuse or drug use;
The researcher believes that the overall condition of the subject affects the evaluation and completion of the trial

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guangzhou Eighth People's Hospital, Guangzhou Medical University	Guangzhou	Guangdong	China	510060

Sponsors and Collaborators

Guangzhou 8th People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Linghua LI, Chief physician, Guangzhou 8th People's Hospital

ClinicalTrials.gov Identifier:

NCT06137196

Other Study ID Numbers:

202326263

First Posted:

Nov 18, 2023

Last Update Posted:

Nov 18, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Linghua LI, Chief physician, Guangzhou 8th People's Hospital

Additional relevant MeSH terms:

Pneumonia

Study Results

No Results Posted as of Nov 18, 2023