Pulmonary Aspergillosis in Tuberculosis Patients

Sponsor
Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05045391
Collaborator
(none)
200
1
132
1.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Prevalence of Chronic Pulmonary Aspergillosis and Antifungal Drug Resistance of Aspergillus Spp. in Pulmonary Tuberculosis Patients in Uzbekistan
Actual Study Start Date :
Jan 1, 2020
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2030

Arms and Interventions

Arm 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
  • Outcome Measures

    Primary Outcome Measures

    1. Aspergillus IgG [2020-2025]

      ELISA of serum of pulmonary tuberculosis patients.

    2. Aspergillus sp. [2020-2025]

      Isolation of Aspergillus sp. among pulmonary tuberculosis patients

    3. Antimicrobial resistance [2020-2025]

      Detection of antimicrobial resistance of fungi

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research institute of epidemiology, microbiology and infectious diseases Tashkent Uchtepa Uzbekistan 100133

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Abdurakhim Toychiev, MD, PhD, Research institute of epidemiology, microbiology and infectious diseases

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Svetlana Osipova, MD, PhD, DS, Head of laboratory of immunology of parasitic and fungal diseases, Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan
    ClinicalTrials.gov Identifier:
    NCT05045391
    Other Study ID Numbers:
    • 1/2021
    First Posted:
    Sep 16, 2021
    Last Update Posted:
    Oct 7, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 7, 2021