Pulmonary Aspergillosis in Tuberculosis Patients

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Aspergillosis; Pulmonary Tuberculoses; Old Tuberculosis; Active Tuberculosis; Chronic Pulmonary Aspergillosis
• Intervention / Treatment: Diagnostic test: Aspergillus IgG detection

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• Uzbekistan
  • Uchtepa
    • Tashkent, Uchtepa, Uzbekistan, 100133
      • Research institute of epidemiology, microbiology and infectious diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Pulmonary tuberculosis patients (smear-positive and smear - negative).

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
pulmonary tuberculosis (smear-positive) patients; Patients with pulmonary tuberculosis (smear-positive). Diagnosis of chronic pulmonary aspergillosis among patients with pulmonary tuberculosis (smear-positive)	Diagnostic test: Aspergillus IgG detection; Aspergillus IgG will be detected among pulmonary tuberculosis patients. 5 ml of vein blood will be collected for ELISA.; Other Names: Mycological analysis of sputum
pulmonary tuberculosis (smear-negative) patients; Patients with pulmonary tuberculosis (smear-positive). Diagnosis of chronic pulmonary aspergillosis among patients with pulmonary tuberculosis (smear-negative)	Diagnostic test: Aspergillus IgG detection; Aspergillus IgG will be detected among pulmonary tuberculosis patients. 5 ml of vein blood will be collected for ELISA.; Other Names: Mycological analysis of sputum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aspergillus IgG	ELISA of serum of pulmonary tuberculosis patients.	2020-2025
Aspergillus sp.	Isolation of Aspergillus sp. among pulmonary tuberculosis patients	2020-2025
Antimicrobial resistance	Detection of antimicrobial resistance of fungi	2020-2025

Collaborators and Investigators

• Sponsor: Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan
• Investigators: Principal Investigator: Abdurakhim Toychiev, MD, PhD, Research institute of epidemiology, microbiology and infectious diseases

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: September 6, 2021
• First Submitted That Met QC Criteria: September 6, 2021
• First Posted (Actual): September 16, 2021

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Lung Diseases, Fungal; Actinomycetales Infections; Mycobacterium Infections; Mycoses; Aspergillosis; Pulmonary Aspergillosis; Tuberculosis; Tuberculosis, Pulmonary
• Other Study ID Numbers: 1/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No