Pulmonary Aspergillosis in Tuberculosis Patients

Aspergillosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05045391
• Other study ID #: 1/2021
• Status: Active, not recruiting
• Start date: January 1, 2020
• Est. completion date: December 31, 2030

Study information

• Verified date: March 2023
• Source: Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Active Tuberculosis
• Aspergillosis
• Chronic Pulmonary Aspergillosis
• Pulmonary Aspergillosis
• Pulmonary Tuberculoses
• Tuberculosis
• Tuberculosis, Pulmonary

Intervention

Diagnostic Test:
• Aspergillus IgG detection
Aspergillus IgG will be detected among pulmonary tuberculosis patients. 5 ml of vein blood will be collected for ELISA.

Locations

Country	Name	City	State
Uzbekistan	Research institute of epidemiology, microbiology and infectious diseases	Tashkent	Uchtepa

Sponsors (1)

Lead Sponsor	Collaborator
Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan

Country where clinical trial is conducted

Uzbekistan, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aspergillus IgG	ELISA of serum of pulmonary tuberculosis patients.	2020-2025
Primary	Aspergillus sp.	Isolation of Aspergillus sp. among pulmonary tuberculosis patients	2020-2025
Primary	Antimicrobial resistance	Detection of antimicrobial resistance of fungi	2020-2025