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Impact of A. Lumbricoides on Pulmonary Aspergillosis Development

Primary Purpose

COPD Exacerbation Acute, Ascaris Lumbricoides Infection, Chronic Pulmonary Aspergillosis

Status
Recruiting
Phase
Not Applicable
Locations
Uzbekistan
Study Type
Interventional
Intervention
Interleukin-1B
Interleukin-4
Interleukin-6
tumor necrosis factor - a
interferon- gamma
Sponsored by
Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COPD Exacerbation Acute focused on measuring COPD, aspergillosis, ascariasis, cytokines, helminths

Eligibility Criteria

30 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Research institute of epidemiology, microbiology and infectious diseasesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

COPD patients without any comorbidities

COPD patients with chronic pulmonary aspergillosis

COPD patients with ascariasis

COPD patients with chronic pulmonary aspergillosis and ascariasis

healthy control

Arm Description

Outcomes

Primary Outcome Measures

Serum interleukin-1B levels in COPD patients and controls
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
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
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
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
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
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
The frequency of ascariasis infestation among COPD patients with and without pulmonary aspergillosis, as well as healthy individuals, will be assessed.

Full Information

First Posted
March 1, 2023
Last Updated
July 27, 2023
Sponsor
Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan
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1. Study Identification

Unique Protocol Identification Number
NCT05783544
Brief Title
Impact of A. Lumbricoides on Pulmonary Aspergillosis Development
Official Title
Role of A. Lumbricoides in the Development of Pulmonary Aspergillosis in Chronic Obstructive Pulmonary Disease Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2015 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD Exacerbation Acute, Ascaris Lumbricoides Infection, Chronic Pulmonary Aspergillosis
Keywords
COPD, aspergillosis, ascariasis, cytokines, helminths

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
COPD patients without any comorbidities
Arm Type
Active Comparator
Arm Title
COPD patients with chronic pulmonary aspergillosis
Arm Type
Active Comparator
Arm Title
COPD patients with ascariasis
Arm Type
Active Comparator
Arm Title
COPD patients with chronic pulmonary aspergillosis and ascariasis
Arm Type
Active Comparator
Arm Title
healthy control
Arm Type
Active Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
Interleukin-1B
Intervention Description
Level of serum interleukin-1B will be detected
Intervention Type
Diagnostic Test
Intervention Name(s)
Interleukin-4
Intervention Description
Level of serum interleukin-4 will be detected
Intervention Type
Diagnostic Test
Intervention Name(s)
Interleukin-6
Intervention Description
Level of serum interleukin-4 will be detected
Intervention Type
Diagnostic Test
Intervention Name(s)
tumor necrosis factor - a
Intervention Description
Level of serum tumor necrosis factor - a will be detected
Intervention Type
Diagnostic Test
Intervention Name(s)
interferon- gamma
Intervention Description
Level of serum interferon- gamma will be detected
Primary Outcome Measure Information:
Title
Serum interleukin-1B levels in COPD patients and controls
Description
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.
Time Frame
up to 12 months
Title
Serum interleukin-4 levels in COPD patients and controls
Description
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.
Time Frame
up to 12 months
Title
Serum interleukin-6 levels in COPD patients and controls
Description
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.
Time Frame
up to 12 months
Title
Serum tumor necrosis factor-a levels in COPD patients and controls
Description
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.
Time Frame
up to 12 months
Title
Serum interferon-gamma levels in COPD patients and controls
Description
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.
Time Frame
up to 12 months
Title
Correlation between cytokine status with chronic pulmonary aspergilosis insidence rate in COPD patients with and without ascariasis
Description
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.
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Rate of ascariasis infestation among COPD patients and controls
Description
The frequency of ascariasis infestation among COPD patients with and without pulmonary aspergillosis, as well as healthy individuals, will be assessed.
Time Frame
up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abdurakhim Dr Toychiev, PhD
Phone
+998901358977
Email
abdurahim1988@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Svetlana Dr Osipova, PhD
Phone
+998712774008
Email
svetosip7@mail.ru
Facility Information:
Facility Name
Research institute of epidemiology, microbiology and infectious diseases
City
Tashkent
State/Province
Uchtepa
ZIP/Postal Code
100133
Country
Uzbekistan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact of A. Lumbricoides on Pulmonary Aspergillosis Development

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