Impact of A. Lumbricoides on Pulmonary Aspergillosis Development

Not Applicable

Recruiting

• Conditions: Ascaris Lumbricoides Infection; Chronic Pulmonary Aspergillosis; COPD Exacerbation Acute
• Interventions: Diagnostic Test: Interleukin-1B; Diagnostic Test: Interleukin-4; Diagnostic Test: Interleukin-6; Diagnostic Test: tumor necrosis factor - a; Diagnostic Test: interferon- gamma

• Registration Number: NCT05783544
• Lead Sponsor: Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-01
• Study First Submitted: 2023-03-01
• Study First Submitted QC: 2023-03-23
• Study First Posted: 2023-03-24
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-27
• Last Update Posted: 2023-08-01
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
COPD patients without any comorbidities	tumor necrosis factor - a	-
COPD patients without any comorbidities	Interleukin-4	-
COPD patients with chronic pulmonary aspergillosis	Interleukin-1B	-
COPD patients without any comorbidities	Interleukin-1B	-
COPD patients with ascariasis	Interleukin-4	-
COPD patients with chronic pulmonary aspergillosis and ascariasis	Interleukin-1B	-
COPD patients with chronic pulmonary aspergillosis	Interleukin-6	-
COPD patients with ascariasis	tumor necrosis factor - a	-
COPD patients with chronic pulmonary aspergillosis and ascariasis	Interleukin-6	-
COPD patients without any comorbidities	Interleukin-6	-
COPD patients without any comorbidities	interferon- gamma	-
healthy control	Interleukin-6	-
COPD patients with chronic pulmonary aspergillosis	interferon- gamma	-
COPD patients with ascariasis	Interleukin-1B	-
COPD patients with chronic pulmonary aspergillosis	Interleukin-4	-
COPD patients with chronic pulmonary aspergillosis	tumor necrosis factor - a	-
COPD patients with ascariasis	Interleukin-6	-
COPD patients with chronic pulmonary aspergillosis and ascariasis	Interleukin-4	-
COPD patients with chronic pulmonary aspergillosis and ascariasis	interferon- gamma	-
COPD patients with ascariasis	interferon- gamma	-
healthy control	tumor necrosis factor - a	-
healthy control	Interleukin-4	-
healthy control	interferon- gamma	-
COPD patients with chronic pulmonary aspergillosis and ascariasis	tumor necrosis factor - a	-
healthy control	Interleukin-1B	-

Primary Outcome Measures

Name	Time	Method
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.
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.
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Research institute of epidemiology, microbiology and infectious diseases; 🇺🇿 Tashkent, Uchtepa, Uzbekistan