Healthcare-Associated Infections in Ukraine and the Activity of 4-Thiazolidinone Derivatives Against Related Pathogens

NCT06508398 | Completed

• 4 other identifiers: 06/25/2018, N6; 06/22/2020, N62020.02/0035FEMS-GO-2020-195Ministry of Health of Ukraine
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to evaluate the species spectrum and biological properties of bacterial and fungal pathogens causing healthcare-associated infections (HAIs) and to investigate the antimicrobial activity of new 4-thiazolidinone derivatives. The main questions it aims to answer are: What are the common pathogens responsible for HAIs in ICU patients? What is the antimicrobial and antifungal efficacy of 4-thiazolidinone derivatives against these pathogens? Participants will have their clinical samples collected and analyzed for pathogen identification and susceptibility testing. The study will involve: Collecting clinical data and samples from ICU patients Conducting microbiological and biochemical tests Screening new antimicrobial compounds for efficacy The study does not involve a comparison group as it focuses on observational data and laboratory analysis.

Conditions

Nosocomial Infection

Keywords

Healthcare-Associated Infections; HAIs; nosocomial infections; antimicrobial resistance; AMR; nosocomial; antibiotic resistance; device-associated pathogens; antimicrobial activity; antifungal activity; 4-thiazolidinones; thiazoles; cellular immunity; immunotropic action; guinea pigs; MALDI; rare pathogens

Outcome Measures

Primary Outcomes (1)

• Incidence of Healthcare-Associated Infections (HAIs)

  The primary outcome measure is to determine the incidence rate of healthcare-associated infections in ICU patients. This will be achieved by collecting and analyzing clinical samples for the presence of bacterial and fungal pathogens. The effectiveness of new 4-thiazolidinone derivatives against these pathogens will also be assessed through antimicrobial susceptibility testing.

  12 months

Secondary Outcomes (1)

• Pathogen Distribution in Healthcare-Associated Infections

  12 months

Other Outcomes (3)

• Clinical Outcomes of ICU Patients with HAIs

  12 months

• Efficacy of 4-Thiazolidinone Derivatives

  12 months

• Antimicrobial Resistance Mechanisms

  12 months

Study Arms (1)

ICU Patients with Healthcare-Associated Infections

This group consists of patients admitted to the Intensive Care Units (ICUs) in Lviv hospitals who are diagnosed with healthcare-associated infections (HAIs). The study involves collecting clinical samples, including blood, urine, sputum, bronchoalveolar lavage, wound swabs, and oropharyngeal/nasopharyngeal swabs, to identify bacterial and fungal pathogens and analyze their antimicrobial resistance profiles. The data collected will be used to evaluate the effectiveness of new 4-thiazolidinone derivatives against these pathogens.

Diagnostic Test: Microbiological Diagnostic Testing

Interventions

Microbiological Diagnostic Testing DIAGNOSTIC_TEST

This study involves microbiological diagnostic testing of clinical samples collected from ICU patients diagnosed with healthcare-associated infections (HAIs). The intervention includes: Sample Collection: Blood, urine, sputum, bronchoalveolar lavage, wound swabs, and oropharyngeal/nasopharyngeal swabs. Pathogen Identification: Using biochemical tests, MALDI-TOF mass spectrometry, and 16S rRNA sequencing to identify bacterial and fungal pathogens. Antimicrobial Susceptibility Testing: Determining the resistance profiles of the identified pathogens to various antimicrobial agents. Evaluation of New Compounds: Testing the antimicrobial efficacy of new 4-thiazolidinone derivatives against isolated pathogens. This comprehensive approach aims to enhance the understanding of pathogen distribution and resistance patterns in HAIs.

Also known as: Pathogen Identification and Antimicrobial Susceptibility Testing

ICU Patients with Healthcare-Associated Infections

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of ICU patients from Lviv hospitals, specifically the Lviv Regional Clinical Hospital, the Military Medical Clinical Center of the Western Region, Lviv Regional Children\'s Clinical Hospital \"Ohmatdyt,\" and the 8th Municipal Clinical Hospital of Lviv. These participants are diagnosed with healthcare-associated infections and will provide clinical samples for pathogen identification and antimicrobial susceptibility testing. The population includes both male and female patients across various age groups, representative of the ICU admissions at these institutions.

You may qualify if:

• Currently hospitalized in an ICU department. Confirmed diagnosis of a nosocomial infection (healthcare-associated infection (HAI)).

You may not qualify if:

• Community-associated pneumonia. Infectious processes that are not related to the provision of medical care.

Sponsors & Collaborators

• Danylo Halytsky Lviv National Medical University: lead

Study Sites (1)

Danylo Halytsky Lviv National Medical University

Lviv, Lviv Oblast, 79010, Ukraine

Location

Related Publications (6)

• Konechnyi Y, Khorkavyi Y, Ivanchuk K, Kobza I, Sekowska A, Korniychuk O. Vibrio metschnikovii: Current state of knowledge and discussion of recently identified clinical case. Clin Case Rep. 2021 Mar 4;9(4):2236-2244. doi: 10.1002/ccr3.3999. eCollection 2021 Apr.

  PMID: 33936672 BACKGROUND

• Lekhniuk N, Fesenko U, Pidhirnyi Y, Sekowska A, Korniychuk O, Konechnyi Y. Raoultella terrigena: Current state of knowledge, after two recently identified clinical cases in Eastern Europe. Clin Case Rep. 2021 Mar 31;9(5):e04089. doi: 10.1002/ccr3.4089. eCollection 2021 May.

  PMID: 34026135 RESULT

• Sekowska A, Konechnyi Y, Gospodarek-Komkowska E. Klebsiella pneumoniae infection in a liver transplant patient: A case report and review of the literature. Indian J Med Microbiol. 2021 Oct-Dec;39(4):548-551. doi: 10.1016/j.ijmmb.2021.07.001. Epub 2021 Jul 24.

  PMID: 34315617 RESULT

• Khamitova capital A, Cyrillic, Berillo D, Lozynskyi A, Konechnyi Y, Mural D, Georgiyants V, Lesyk R. Thiadiazole and Thiazole Derivatives as Potential Antimicrobial Agents. Mini Rev Med Chem. 2024;24(5):531-545. doi: 10.2174/1389557523666230713115947.

  PMID: 37448365 RESULT

• Konechnyi Y, Panas M, Tymchuk I, Havur O, Borysiuk O, Hubytska I, Zhurakhivska L, Konechna R, Korniychuk O. Epidemiological and microbiological aspects of healthcare-associated infections in Ukraine during the 2009-2019 period. Przegl Epidemiol. 2021;75(1):86-95. doi: 10.32394/pe.75.09.

  PMID: 34338474 RESULT

• Konechnyi Y, Rumynska T, Yushyn I, Holota S, Turkina V, Ryviuk Rydel M, Sekowska A, Salyha Y, Korniychuk O, Lesyk R. A New 4-Thiazolidinone Derivative (Les-6490) as a Gut Microbiota Modulator: Antimicrobial and Prebiotic Perspectives. Antibiotics (Basel). 2024 Mar 22;13(4):291. doi: 10.3390/antibiotics13040291.

  PMID: 38666967 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

The specific types of samples that will be retained include: * Blood Samples: Venous blood for microbiological and biochemical analysis. * Urine Samples: From the urinary bladder for pathogen detection. * Sputum Samples: Respiratory tract microbiological testing. * Bronchoalveolar Lavage (BAL) Samples: From lungs to identify respiratory pathogens. * Wound Swabs: From wound sites for bacterial identification. * Oropharyngeal/Nasopharyngeal Swabs: Throat and nasal passages for pathogen detection. * Stool Samples: Gastrointestinal pathogen analysis. All samples will be preserved and may be used for DNA extraction to study genetic aspects of pathogen resistance and infection.

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yulian Konechnyi, PhD

  Danylo Halytsky Lviv National Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2024
• First Posted: July 18, 2024
• Study Start: September 1, 2017
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2024
• Last Updated: August 1, 2024

Record last verified: 2024-07

Locations

UA (1)