Pulmonary Aspergillosis in Tuberculosis Patients

NCT ID: NCT05045391

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2030-12-31

Brief 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.

Detailed 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.

Conditions

Pulmonary Tuberculoses; Aspergillosis; Old Tuberculosis; Active Tuberculosis; Chronic Pulmonary Aspergillosis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

pulmonary tuberculosis (smear-positive) patients

Patients with pulmonary tuberculosis (smear-positive). Diagnosis of chronic pulmonary aspergillosis among patients with pulmonary tuberculosis (smear-positive)

Aspergillus IgG detection

Intervention Type: DIAGNOSTIC_TEST

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

pulmonary tuberculosis (smear-negative) patients

Patients with pulmonary tuberculosis (smear-positive). Diagnosis of chronic pulmonary aspergillosis among patients with pulmonary tuberculosis (smear-negative)

Aspergillus IgG detection

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Aspergillus IgG detection

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Mycological analysis of sputum

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Svetlana Osipova, MD, PhD, DS

Head of laboratory of immunology of parasitic and fungal diseases

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abdurakhim Toychiev, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Research institute of epidemiology, microbiology and infectious diseases

Locations

Research institute of epidemiology, microbiology and infectious diseases

Tashkent, Uchtepa, Uzbekistan

Countries

Uzbekistan

References

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(4):515-521. doi: 10.1177/00494755221110678. Epub 2022 Jun 30.

Reference Type: BACKGROUND

PMID: 35770798 (View on PubMed)

Other Identifiers

1/2021

Identifier Type: -

Identifier Source: org_study_id