Comprehensive Diagnosis and Treatment Strategy for Opportunistic Fungal Infections in AIDS Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- The number of patients who achieved etiological diagnosis of opportunistic fungal infection
研究概览
简要总结
Opportunistic fungal infection is the most common opportunistic infection in AIDS patients, with the high mortality and recurrence rate due to the lack of standardized comprehensive diagnosis and treatment strategy. This project aims to combine traditional detection and observation indicators with molecular biology, serology and mass spectrometry identification technology to develop early screening and diagnostic strategies for opportunistic fungal infections in AIDS patients, explore scientific evaluation methods for anti-fungal efficacy and formulate comprehensive strategies for reducing the mortality and recurrence rate.
详细描述
The research involves AIDS patients complicated with talaromycosis, PCP and cryptococcosis in the study.
The main contents:
- To explore early screening and diagnostic strategies. To advance the application of taloromyces marneffeispecific mannose protein (Mp1p), (1,3)- β- D-glucan (G antigen) and Cryptococcus capsular antigen (CrAg) serological detection, qPCR, dd- PCR and mass spectrometry identification In clinical practice.
- To develop scientific evaluation strategy of anti-fungal treatment effect. On the basis of routine clinical, laboratory, imaging indexes and QFC, qPCR, dd-PCR and serological quantitative detection methods were combined to explore strategies for evaluating anti-fungal efficacy. 3 .To determine the termination timing of secondary prevention To explore the scientific timing to terminate secondary prevention after ART, Combing CD4 + T cell count with plasma HIV RNA, HIV DNA of peripheral blood mononuclear cells (PBMC), CD4 + / CD8+ ratio and chronic immune activation index
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age (16-70 years), male and female;
- •HIV-1 infected;
- •hospitalized patients with the signs or symptoms inferred to infection;
- •Initial CD4 cell count less than 200 cells/ul; HIV-1 RNA viral load was unlimited;
- •State Informed Consent for Free Treatment has been signed;
- •Good compliance and signing Informed Consent
排除标准
- •have been treated regularly in other hospitals or have been clearly diagnosed before admission;
- •Researchers decide if patients could/not complete the scheduled follow-up (factors to consider such as weak, poor compliance, etc.);
- •Pregnancy during the study period;
- •Hospital stay less than 7 days.
结局指标
主要结局
The number of patients who achieved etiological diagnosis of opportunistic fungal infection
时间窗: 2 weeks
The probability of etiological diagnosis achieved by new diagnostic techniques after admission
Number of hospitalized patients who achieved clinical remission or cure
时间窗: 6 months
The improvement of treatment efficiency for treating with 3 main opportunistic fungal infections in AIDS patients when applying with new diagnostic techniques
次要结局
未报告次要终点
研究者
Linghua LI
Chief physician
Guangzhou 8th People's Hospital