Pulmonary Aspergillosis in Tuberculosis Patients

Active, not recruiting

• Conditions: Old Tuberculosis; Chronic Pulmonary Aspergillosis; Pulmonary Tuberculoses; Aspergillosis; Active Tuberculosis
• Interventions: Diagnostic Test: Aspergillus IgG detection

• Registration Number: NCT05045391
• Lead Sponsor: Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan

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.

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2021-09-06
• Study First Submitted QC: 2021-09-06
• Study First Posted: 2021-09-16
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04
• Primary Completion: 2025-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
pulmonary tuberculosis (smear-positive) patients	Aspergillus IgG detection	Patients with pulmonary tuberculosis (smear-positive). Diagnosis of chronic pulmonary aspergillosis among patients with pulmonary tuberculosis (smear-positive)
pulmonary tuberculosis (smear-negative) patients	Aspergillus IgG detection	Patients with pulmonary tuberculosis (smear-positive). Diagnosis of chronic pulmonary aspergillosis among patients with pulmonary tuberculosis (smear-negative)

Primary Outcome Measures

Name	Time	Method
Aspergillus IgG	2020-2025	ELISA of serum of pulmonary tuberculosis patients.
Aspergillus sp.	2020-2025	Isolation of Aspergillus sp. among pulmonary tuberculosis patients
Antimicrobial resistance	2020-2025	Detection of antimicrobial resistance of fungi

Trial Locations

Locations (1)

Research institute of epidemiology, microbiology and infectious diseases; 🇺🇿 Tashkent, Uchtepa, Uzbekistan