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Pulmonary Aspergillosis in Tuberculosis Patients

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05045391
Enrollment
200
Registered
2021-09-16
Start date
2020-01-01
Completion date
2030-12-31
Last updated
2025-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Active Tuberculosis, Aspergillosis, Chronic Pulmonary Aspergillosis, Old Tuberculosis, Pulmonary Tuberculoses

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.

Interventions

DIAGNOSTIC_TESTAspergillus IgG detection

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

Sponsors

Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Aspergillus IgG2020-2025ELISA of serum of pulmonary tuberculosis patients.
Aspergillus sp.2020-2025Isolation of Aspergillus sp. among pulmonary tuberculosis patients
Antimicrobial resistance2020-2025Detection of antimicrobial resistance of fungi

Countries

Uzbekistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026