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Active, Not Recruiting

NCT Number: NCT05045391

Pulmonary Aspergillosis in Tuberculosis Patients

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pulmonary Tuberculoses Actinomycetales Infections Active Tuberculosis Aspergillosis Bacterial Infections Bacterial Infections and Mycoses Chronic Pulmonary Aspergillosis Gram-Positive Bacterial Infections Infections Latent Infection Latent Tuberculosis Lung Diseases Mycobacterium Infections Mycoses Old Tuberculosis Respiratory Tract Diseases Respiratory Tract Infections Tuberculosis Tuberculosis, Pulmonary

Age range

19 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research institute of epidemiology, microbiology and infectious diseases

Tashkent, Uchtepa, 100133, Uzbekistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aspergillus IgG detection

Diagnostic Test

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

Primary outcomes

  1. Aspergillus IgG

    Time frame: 2020-2025

    ELISA of serum of pulmonary tuberculosis patients.

  2. Aspergillus sp.

    Time frame: 2020-2025

    Isolation of Aspergillus sp. among pulmonary tuberculosis patients

  3. Antimicrobial resistance

    Time frame: 2020-2025

    Detection of antimicrobial resistance of fungi

Sponsors and collaborators

Lead sponsor

Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan

Other Gov

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2030
First posted
Sep 16, 2021
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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