Pulmonary Aspergillosis in Tuberculosis Patients

NCT05045391 | Active Not Recruiting DMC

• 1 other identifier: 1/2021
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Tuberculoses; Aspergillosis; Old Tuberculosis; Active Tuberculosis; Chronic Pulmonary Aspergillosis

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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

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

Interventions

Aspergillus IgG detection DIAGNOSTIC_TEST

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

Also known as: Mycological analysis of sputum

pulmonary tuberculosis (smear-negative) patients; pulmonary tuberculosis (smear-positive) patients

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Pulmonary tuberculosis patients (smear-positive)
• Pulmonary tuberculosis patients (smear - negative)

You may not qualify if:

• neutropenia
• severe immunosuppression caused by cancer chemotherapy
• hematopoietic stem cell or solid organ transplantation
• HIV infected individuals

Sponsors & Collaborators

• Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan: lead

Study Sites (1)

Research institute of epidemiology, microbiology and infectious diseases

Tashkent, Uchtepa, 100133, Uzbekistan

Location

Related 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(4):515-521. doi: 10.1177/00494755221110678. Epub 2022 Jun 30.

  PMID: 35770798 BACKGROUND

MeSH Terms

Conditions

Tuberculosis, Pulmonary; Aspergillosis; Latent Tuberculosis

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Mycoses; Latent Infection

Study Officials

• Abdurakhim Toychiev, MD, PhD

  Research institute of epidemiology, microbiology and infectious diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of laboratory of immunology of parasitic and fungal diseases

Study Record Dates

• First Submitted: September 6, 2021
• First Posted: September 16, 2021
• Study Start: January 1, 2020
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 4, 2025

Record last verified: 2025-04

Locations

UZ (1)