Impact of A. Lumbricoides on Pulmonary Aspergillosis Development

NCT ID: NCT05783544

Last Updated: 2023-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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COPD Exacerbation Acute Ascaris Lumbricoides Infection Chronic Pulmonary Aspergillosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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COPD patients without any comorbidities

Group Type ACTIVE_COMPARATOR

Interleukin-1B

Intervention Type DIAGNOSTIC_TEST

Level of serum interleukin-1B will be detected

Interleukin-4

Intervention Type DIAGNOSTIC_TEST

Level of serum interleukin-4 will be detected

Interleukin-6

Intervention Type DIAGNOSTIC_TEST

Level of serum interleukin-4 will be detected

tumor necrosis factor - a

Intervention Type DIAGNOSTIC_TEST

Level of serum tumor necrosis factor - a will be detected

interferon- gamma

Intervention Type DIAGNOSTIC_TEST

Level of serum interferon- gamma will be detected

COPD patients with chronic pulmonary aspergillosis

Group Type ACTIVE_COMPARATOR

Interleukin-1B

Intervention Type DIAGNOSTIC_TEST

Level of serum interleukin-1B will be detected

Interleukin-4

Intervention Type DIAGNOSTIC_TEST

Level of serum interleukin-4 will be detected

Interleukin-6

Intervention Type DIAGNOSTIC_TEST

Level of serum interleukin-4 will be detected

tumor necrosis factor - a

Intervention Type DIAGNOSTIC_TEST

Level of serum tumor necrosis factor - a will be detected

interferon- gamma

Intervention Type DIAGNOSTIC_TEST

Level of serum interferon- gamma will be detected

COPD patients with ascariasis

Group Type ACTIVE_COMPARATOR

Interleukin-1B

Intervention Type DIAGNOSTIC_TEST

Level of serum interleukin-1B will be detected

Interleukin-4

Intervention Type DIAGNOSTIC_TEST

Level of serum interleukin-4 will be detected

Interleukin-6

Intervention Type DIAGNOSTIC_TEST

Level of serum interleukin-4 will be detected

tumor necrosis factor - a

Intervention Type DIAGNOSTIC_TEST

Level of serum tumor necrosis factor - a will be detected

interferon- gamma

Intervention Type DIAGNOSTIC_TEST

Level of serum interferon- gamma will be detected

COPD patients with chronic pulmonary aspergillosis and ascariasis

Group Type ACTIVE_COMPARATOR

Interleukin-1B

Intervention Type DIAGNOSTIC_TEST

Level of serum interleukin-1B will be detected

Interleukin-4

Intervention Type DIAGNOSTIC_TEST

Level of serum interleukin-4 will be detected

Interleukin-6

Intervention Type DIAGNOSTIC_TEST

Level of serum interleukin-4 will be detected

tumor necrosis factor - a

Intervention Type DIAGNOSTIC_TEST

Level of serum tumor necrosis factor - a will be detected

interferon- gamma

Intervention Type DIAGNOSTIC_TEST

Level of serum interferon- gamma will be detected

healthy control

Group Type ACTIVE_COMPARATOR

Interleukin-1B

Intervention Type DIAGNOSTIC_TEST

Level of serum interleukin-1B will be detected

Interleukin-4

Intervention Type DIAGNOSTIC_TEST

Level of serum interleukin-4 will be detected

Interleukin-6

Intervention Type DIAGNOSTIC_TEST

Level of serum interleukin-4 will be detected

tumor necrosis factor - a

Intervention Type DIAGNOSTIC_TEST

Level of serum tumor necrosis factor - a will be detected

interferon- gamma

Intervention Type DIAGNOSTIC_TEST

Level of serum interferon- gamma will be detected

Interventions

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Interleukin-1B

Level of serum interleukin-1B will be detected

Intervention Type DIAGNOSTIC_TEST

Interleukin-4

Level of serum interleukin-4 will be detected

Intervention Type DIAGNOSTIC_TEST

Interleukin-6

Level of serum interleukin-4 will be detected

Intervention Type DIAGNOSTIC_TEST

tumor necrosis factor - a

Level of serum tumor necrosis factor - a will be detected

Intervention Type DIAGNOSTIC_TEST

interferon- gamma

Level of serum interferon- gamma will be detected

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Svetlana Osipova, MD, PhD, DS

Head of Department of Immunology of Parasitic and Fungal Diseases

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Research institute of epidemiology, microbiology and infectious diseases

Tashkent, Uchtepa, Uzbekistan

Site Status RECRUITING

Countries

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Uzbekistan

Central Contacts

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Abdurakhim Dr Toychiev, PhD

Role: CONTACT

+998901358977

Svetlana Dr Osipova, PhD

Role: CONTACT

+998712774008

Other Identifiers

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01032023

Identifier Type: -

Identifier Source: org_study_id

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