Pulmonary TuberculosesNCT05045391
Pulmonary Aspergillosis in Tuberculosis Patients
An observational study of Pulmonary Tuberculoses and Aspergillosis, run by Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan at 1 site in Uzbekistan.
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… Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Pulmonary Tuberculoses, Aspergillosis, Old Tuberculosis
- What is being tested?
- Aspergillus IgG detection
- How many people
- 200 participants
- Where
- 1 siteUzbekistan
- Study dates
- 1 Jan 2020to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pulmonary tuberculosis patients (smear-positive and smear - negative).
Who may be able to join
- Pulmonary tuberculosis patients (smear-positive)
- Pulmonary tuberculosis patients (smear - negative)
Who cannot join
- neutropenia
- severe immunosuppression caused by cancer chemotherapy
- hematopoietic stem cell or solid organ transplantation
- HIV infected individuals
Trial locations and contacts
1 site in 1 country.
Uzbekistan1 site
Research institute of epidemiology, microbiology and infectious diseases
Tashkent, Uchtepa, 100133
About this study
Official title: Prevalence of Chronic Pulmonary Aspergillosis and Antifungal Drug Resistance of Aspergillus Spp. in Pulmonary Tuberculosis Patients in Uzbekistan
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.
Read the 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.
- Conditions
- Pulmonary Tuberculoses, Aspergillosis, Old Tuberculosis, Active Tuberculosis, Chronic Pulmonary Aspergillosis
- Being tested
- Aspergillus IgG detection
- Medical subject headings
- Tuberculosis, Pulmonary, Aspergillosis, Latent Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspergillus IgG detectionDiagnostic test
Also called Mycological analysis of sputum
Aspergillus IgG will be detected among pulmonary tuberculosis patients. 5 ml of vein blood will be collected for ELISA.
| Study group | Role | What they receive |
|---|---|---|
| pulmonary tuberculosis (smear-positive) patients | Patients with pulmonary tuberculosis (smear-positive). Diagnosis of chronic pulmonary aspergillosis among patients with pulmonary tuberculosis (smear-positive) Receives: 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) Receives: Diagnostic Test: Aspergillus IgG detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aspergillus IgG
ELISA of serum of pulmonary tuberculosis patients.
Measured: 2020-2025
Aspergillus sp.
Isolation of Aspergillus sp. among pulmonary tuberculosis patients
Measured: 2020-2025
Antimicrobial resistance
Detection of antimicrobial resistance of fungi
Measured: 2020-2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start1 Jan 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary TuberculosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Svetlana Osipova, MD, PhD, DS, Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan
- Investigators
- Abdurakhim Toychiev, MD, PhD, Principal investigator, Research institute of epidemiology, microbiology and infectious diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05045391
- Sponsor's protocol ID
- 1/2021
- Status last verified
- Apr 2025
- First submitted
- 6 Sep 2021
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35770798
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Chronic Pulmonary Aspergillosis and Antifungal Drug Resistance of Aspergillus Spp. in Pulmonary Tuberculosis Patients in Uzbekistan
- ClinicalTrials.gov ID
- NCT05045391
- Acronym / sponsor ID
- 1/2021
- Conditions
- Pulmonary Tuberculoses, Aspergillosis, Old Tuberculosis, Active Tuberculosis, Chronic Pulmonary Aspergillosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Research Institute of Epidemiology, Microbiology and Infectious Diseases, UzbekistanOther government
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 16 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pulmonary tuberculosis (smear-positive) patients | – | Diagnostic Test: Aspergillus IgG detectionPatients with pulmonary tuberculosis (smear-positive). Diagnosis of chronic pulmonary aspergillosis among patients with pulmonary tuberculosis (smear-positive) |
| pulmonary tuberculosis (smear-negative) patients | – | Diagnostic Test: Aspergillus IgG detectionPatients with pulmonary tuberculosis (smear-positive). Diagnosis of chronic pulmonary aspergillosis among patients with pulmonary tuberculosis (smear-negative) |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pulmonary tuberculosis patients (smear-positive and smear - negative).
Key inclusion criteria (2 listed)
- Pulmonary tuberculosis patients (smear-positive)
- Pulmonary tuberculosis patients (smear - negative)
Key exclusion criteria (4 listed)
- neutropenia
- severe immunosuppression caused by cancer chemotherapy
- hematopoietic stem cell or solid organ transplantation
- HIV infected individuals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspergillus IgG detectionAlso: Mycological analysis of sputumAspergillus IgG will be detected among pulmonary tuberculosis patients. 5 ml of vein blood will be collected for ELISA. | Diagnostic test | pulmonary tuberculosis (smear-negative) patients, pulmonary tuberculosis (smear-positive) patients |
Primary outcome
Aspergillus IgG
Time frame: 2020-2025
ELISA of serum of pulmonary tuberculosis patients.
Aspergillus sp.
Time frame: 2020-2025
Isolation of Aspergillus sp. among pulmonary tuberculosis patients
Antimicrobial resistance
Time frame: 2020-2025
Detection of antimicrobial resistance of fungi
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Results publication: PubMed 35770798Toychiev 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.
- Individual participant dataSharing planned: Undecided
Related trials for Pulmonary Tuberculoses
RecruitingPhase 4
Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease
Mycobacterium Avium Complex Pulmonary Disease
Active, not recruitingObservational study
Mycobacterial and Opportunistic Infections in HIV-Negative Thai and Taiwanese Patients Associated With Autoantibodies to Interferon-gamma
Nontuberculous Mycobacteria, Mycobacterium Tuberculosis
RecruitingPhase 2
BRIGHT-Child TB: Short-Course Treatment for Non-Severe Pulmonary Tuberculosis in Children
Tuberculosis
RecruitingPhase 3
A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis
Rifampicin-Resistant Pulmonary Tuberculosis, Multidrug-Resistant Pulmonary Tuberculosis
Recruiting
Channa Striata and Curcuma Domestica Supplementation in Patients With Active Pulmonary Tuberculosis
Pulmonary Tuberculosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdurakhim Toychiev, MD, PhD principal investigator
Research institute of epidemiology, microbiology and infectious diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Tuberculoses and Aspergillosis, run by Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan at 1 site in Uzbekistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uzbekistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aspergillus IgG (time frame: 2020-2025). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05045391, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.