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

NCT06137196 | Recruiting

• 1 other identifier: 202326263
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

AIDS; Pneumonia

Keywords

AIDS; Severe pneumonia; Lung function; Predictive factors

Outcome Measures

Primary Outcomes (1)

• Obstructive Ventilatory Dysfunction

  FEV1(Forced Expiratory Volume in One Second )to FVC (Forced Vital Capacity ) Ratio

  12 weeks

Secondary Outcomes (1)

• FEV1

  12 weeks

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All study participants come from the HIV/HBV co-infection cohort at the Guangzhou Eighth People's Hospital.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangzhou 8th People's Hospital: lead

Study Sites (1)

Guangzhou Eighth People's Hospital, Guangzhou Medical University

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Pneumonia

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Linghua Li, PhD

CONTACT

+862083710825; llheliza@126.com

Yaozu He, MD

CONTACT

15626444697; hyzdyl99@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 18, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)