Risk Identification Factors for Pulmonary Function Impairment in AIDS Patients Recovered From Severe Pneumonia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: AIDS, Pneumonia. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Study on Risk Identification Factors for Lung Function Impairment in AIDS Patients Recovered From Severe Pneumonia
Overview
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
Primary outcome measures
- Obstructive Ventilatory Dysfunction [Time frame: 12 weeks]
Secondary outcome measures (1)
- FEV1 [Time frame: 12 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Guangzhou Eighth People's Hospital, Guangzhou Medical University — Guangzhou
Identifiers
NCT: NCT06137196 · 202326263