Impact of A. Lumbricoides on Pulmonary Aspergillosis Development

July 27, 2023 updated by: Svetlana Osipova, MD, PhD, DS, Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Svetlana Dr Osipova, PhD
  • Phone Number: +998712774008
  • Email: svetosip7@mail.ru

Study Locations

  • Uzbekistan
    • Uchtepa
      • Tashkent, Uchtepa, Uzbekistan, 100133
        • Recruiting
        • Research institute of epidemiology, microbiology and infectious diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum interleukin-1B levels in COPD patients and controls
Time Frame: 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.
up to 12 months
Serum interleukin-4 levels in COPD patients and controls
Time Frame: 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.
up to 12 months
Serum interleukin-6 levels in COPD patients and controls
Time Frame: 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.
up to 12 months
Serum tumor necrosis factor-a levels in COPD patients and controls
Time Frame: 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.
up to 12 months
Serum interferon-gamma levels in COPD patients and controls
Time Frame: 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.
up to 12 months
Correlation between cytokine status with chronic pulmonary aspergilosis insidence rate in COPD patients with and without ascariasis
Time Frame: 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.
up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of ascariasis infestation among COPD patients and controls
Time Frame: 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.
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

March 1, 2023

First Submitted That Met QC Criteria

March 23, 2023

First Posted (Actual)

March 24, 2023

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 27, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01032023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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