Impact of A. Lumbricoides on Pulmonary Aspergillosis Development

Sponsor

Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05783544

Collaborator

(none)

200

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The prevalence of ascariasis in COPD patients with and without concomitant pulmonary aspergillosis and in controls will be determined. To assess the influence of ascaridosis on the development of pulmonary aspergillosis in COPD patients cytokine status of patients will be studied.

Condition or Disease	Intervention/Treatment	Phase
COPD Exacerbation Acute Ascaris Lumbricoides Infection Chronic Pulmonary Aspergillosis	Diagnostic Test: Interleukin-1B Diagnostic Test: Interleukin-4 Diagnostic Test: Interleukin-6 Diagnostic Test: tumor necrosis factor - a Diagnostic Test: interferon- gamma	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Role of A. Lumbricoides in the Development of Pulmonary Aspergillosis in Chronic Obstructive Pulmonary Disease Patients

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: COPD patients without any comorbidities	Diagnostic Test: Interleukin-1B Level of serum interleukin-1B will be detected Diagnostic Test: Interleukin-4 Level of serum interleukin-4 will be detected Diagnostic Test: Interleukin-6 Level of serum interleukin-4 will be detected Diagnostic Test: tumor necrosis factor - a Level of serum tumor necrosis factor - a will be detected Diagnostic Test: interferon- gamma Level of serum interferon- gamma will be detected
Active Comparator: COPD patients with chronic pulmonary aspergillosis	Diagnostic Test: Interleukin-1B Level of serum interleukin-1B will be detected Diagnostic Test: Interleukin-4 Level of serum interleukin-4 will be detected Diagnostic Test: Interleukin-6 Level of serum interleukin-4 will be detected Diagnostic Test: tumor necrosis factor - a Level of serum tumor necrosis factor - a will be detected Diagnostic Test: interferon- gamma Level of serum interferon- gamma will be detected
Active Comparator: COPD patients with ascariasis	Diagnostic Test: Interleukin-1B Level of serum interleukin-1B will be detected Diagnostic Test: Interleukin-4 Level of serum interleukin-4 will be detected Diagnostic Test: Interleukin-6 Level of serum interleukin-4 will be detected Diagnostic Test: tumor necrosis factor - a Level of serum tumor necrosis factor - a will be detected Diagnostic Test: interferon- gamma Level of serum interferon- gamma will be detected
Active Comparator: COPD patients with chronic pulmonary aspergillosis and ascariasis	Diagnostic Test: Interleukin-1B Level of serum interleukin-1B will be detected Diagnostic Test: Interleukin-4 Level of serum interleukin-4 will be detected Diagnostic Test: Interleukin-6 Level of serum interleukin-4 will be detected Diagnostic Test: tumor necrosis factor - a Level of serum tumor necrosis factor - a will be detected Diagnostic Test: interferon- gamma Level of serum interferon- gamma will be detected
Active Comparator: healthy control	Diagnostic Test: Interleukin-1B Level of serum interleukin-1B will be detected Diagnostic Test: Interleukin-4 Level of serum interleukin-4 will be detected Diagnostic Test: Interleukin-6 Level of serum interleukin-4 will be detected Diagnostic Test: tumor necrosis factor - a Level of serum tumor necrosis factor - a will be detected Diagnostic Test: interferon- gamma Level of serum interferon- gamma will be detected

Outcome Measures

Primary Outcome Measures

Serum interleukin-1B levels in COPD patients and controls [up to 12 months]
Serum interleukin-1B (pg/mL) levels will be measured in COPD patients without concomitant infection, COPD patients with pulmonary aspergillosis, COPD patients with ascariasis, COPD patients with ascariasis and pulmonary aspergillosis, and healthy individuals.
Serum interleukin-4 levels in COPD patients and controls [up to 12 months]
Serum interleukin-4 (pg/mL) levels will be measured in COPD patients without concomitant infection, COPD patients with pulmonary aspergillosis, COPD patients with ascariasis, COPD patients with ascariasis and pulmonary aspergillosis, and healthy individuals.
Serum interleukin-6 levels in COPD patients and controls [up to 12 months]
Serum interleukin-6 (pg/mL) levels will be measured in COPD patients without concomitant infection, COPD patients with pulmonary aspergillosis, COPD patients with ascariasis, COPD patients with ascariasis and pulmonary aspergillosis, and healthy individuals.
Serum tumor necrosis factor-a levels in COPD patients and controls [up to 12 months]
Serum tumor necrosis factor-a (pg/mL) levels will be measured in COPD patients without concomitant infection, COPD patients with pulmonary aspergillosis, COPD patients with ascariasis, COPD patients with ascariasis and pulmonary aspergillosis, and healthy individuals.
Serum interferon-gamma levels in COPD patients and controls [up to 12 months]
Serum interferon-gamma (pg/mL) levels will be measured in COPD patients without concomitant infection, COPD patients with pulmonary aspergillosis, COPD patients with ascariasis, COPD patients with ascariasis and pulmonary aspergillosis, and healthy individuals.
Correlation between cytokine status with chronic pulmonary aspergilosis insidence rate in COPD patients with and without ascariasis [up to 12 months]
The correlation between serum interleukin-1B, interleukin-4, interleukin-6, tumor necrosis factor-a and interferon-y levels with chronic pulmonary aspergilosis insidence rate in COPD patients with and without ascariasis will be assessed.

Secondary Outcome Measures

Rate of ascariasis infestation among COPD patients and controls [up to 12 months]
The frequency of ascariasis infestation among COPD patients with and without pulmonary aspergillosis, as well as healthy individuals, will be assessed.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

COPD patients
COPD patients with aspergillosis
COPD patients with ascariasis
COPD patients with mix-infection
Healthy individuals (controls)

Exclusion Criteria:

COPD patients with other autoimmune diseases
COPD patients with oncological diseases
COPD patients with other co-infections

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Svetlana Osipova, MD, PhD, DS, Head of Department of Immunology of Parasitic and Fungal Diseases, Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan

ClinicalTrials.gov Identifier:

NCT05783544

Other Study ID Numbers:

01032023

First Posted:

Mar 24, 2023

Last Update Posted:

Mar 24, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Svetlana Osipova, MD, PhD, DS, Head of Department of Immunology of Parasitic and Fungal Diseases, Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan

Additional relevant MeSH terms:

Aspergillosis

Pulmonary Aspergillosis

Interferons

Interferon-gamma

Interleukin-4

Study Results

No Results Posted as of Mar 24, 2023