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

NCT ID: NCT06137196

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-01

Study Completion Date

2027-11-01

Brief Summary

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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

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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

Conditions

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AIDS Pneumonia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangzhou 8th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Linghua LI

Chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Guangzhou Eighth People's Hospital, Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Linghua Li, PhD

Role: CONTACT

+862083710825

Yaozu He, MD

Role: CONTACT

15626444697

Facility Contacts

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Linghua Li, PhD

Role: primary

+862083710825

Yaozu He, Master

Role: backup

+862083710825

Other Identifiers

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202326263

Identifier Type: -

Identifier Source: org_study_id

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