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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05045391
Other study ID # 1/2021
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date December 31, 2030

Study information

Verified date March 2023
Source Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 200
Est. completion date December 31, 2030
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 19 Years to 90 Years
Eligibility Inclusion Criteria: - Pulmonary tuberculosis patients (smear-positive) - Pulmonary tuberculosis patients (smear - negative) Exclusion Criteria: - neutropenia - severe immunosuppression caused by cancer chemotherapy - hematopoietic stem cell or solid organ transplantation - HIV infected individuals

Study Design


Intervention

Diagnostic Test:
Aspergillus IgG detection
Aspergillus IgG will be detected among pulmonary tuberculosis patients. 5 ml of vein blood will be collected for ELISA.

Locations

Country Name City State
Uzbekistan Research institute of epidemiology, microbiology and infectious diseases Tashkent Uchtepa

Sponsors (1)

Lead Sponsor Collaborator
Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan

Country where clinical trial is conducted

Uzbekistan, 

References & Publications (1)

Toychiev A, Belotserkovets V, Ignat'ev N, Madrakhimov S, Shaislamova M, Osipova S. Prevalence of chronic pulmonary aspergillosis and the antifungal drug resistance of Aspergillusspp. in pulmonary tuberculosis patients in Uzbekistan. Trop Doct. 2022 Oct;52 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Aspergillus IgG ELISA of serum of pulmonary tuberculosis patients. 2020-2025
Primary Aspergillus sp. Isolation of Aspergillus sp. among pulmonary tuberculosis patients 2020-2025
Primary Antimicrobial resistance Detection of antimicrobial resistance of fungi 2020-2025
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