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临床试验/NCT05045391
NCT05045391进行中(未招募)不适用

Prevalence of Chronic Pulmonary Aspergillosis and Antifungal Drug Resistance of Aspergillus Spp. in Pulmonary Tuberculosis Patients in Uzbekistan

Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
200
试验地点
1
主要终点
Aspergillus IgG

研究概览

简要总结

Pulmonary tuberculosis (PTB) is the most common cause of lung destruction, contributing to coinfections development, and Aspergillosis spp. is one of the most important. Diagnosis of chronic pulmonary aspergillosis (CPA) in PTB patients is difficult due to similarity of clinical and radiological data, especially in resource-constrained settings. Differentiation of PTB patients with singling out a group with a higher Aspergillus IgG level during the initial examination will help physicians to orient to further examination of CPA.

Objectives: to determine the prevalence of aspergillosis in Koch's bacillus-positive and Koch's bacillus-negative PTB patients and antifungal resistance of Aspergillus species isolates in Central Asia countries.

详细描述

Chronic pulmonary aspergillosis (CPA) complicates treated pulmonary tuberculosis (PTB), with high 5-year mortality. PTB affected an estimated 10.4 million people in 2016. Just 57% of PTB cases reported to the World Health Organization (WHO) were bacteriologically confirmed. CPA both complicates and mimics treated PTB. The prevalence of CPA in patients with treated TB and the contribution of misdiagnosed CPA to PTB prevalence estimates are unclear.

Mycological analysis of sputum for Aspergillus is often negative in CPA. Detection of Aspergillus IgG is one of the main analysis in CPA diagnosis, but until recently had been inadequately validated for use in this context. Both tests are infrequently available in areas of high PTB prevalence.

Antifungal therapy improves survival. But, survival rates vary significantly among published studies. Reported survival rates are 58%-93% at 1 year of follow-up, 17.5%-85% at 5 years of follow-up, and 30%-50% at 10 years of follow-up. In a selected group of patients with CPA, weekly subcutaneous injections of IFNγ has been shown to improve disease control and also helps with bacterial clearance. Several factors have been reported to affect mortality, including by underlying pulmonary disease, advanced age, NTM infection, quality of life scores, and serum albumin levels. No data on the prevalence of CPA among patients with PTB and resistance of Aspergillus spp. to antifungal drugs in Uzbekistan and neighboring countries.

The aim of the study is to determine the prevalence of aspergillosis in Koch's bacillus-positive and Koch's bacillus-negative PTB patients and antifungal resistance of Aspergillus species isolates in Central Asia countries.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
19 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Pulmonary tuberculosis patients (smear-positive)
  • Pulmonary tuberculosis patients (smear - negative)

排除标准

  • neutropenia
  • severe immunosuppression caused by cancer chemotherapy
  • hematopoietic stem cell or solid organ transplantation
  • HIV infected individuals

结局指标

主要结局

Aspergillus IgG

时间窗: 2020-2025

ELISA of serum of pulmonary tuberculosis patients.

Aspergillus sp.

时间窗: 2020-2025

Isolation of Aspergillus sp. among pulmonary tuberculosis patients

Antimicrobial resistance

时间窗: 2020-2025

Detection of antimicrobial resistance of fungi

次要结局

未报告次要终点

研究者

发起方
Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Svetlana Osipova, MD, PhD, DS

Head of laboratory of immunology of parasitic and fungal diseases

Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan

研究点 (1)

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