Indwelling Device-associated Biofilms

NCT04328818 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2022-03-16

No results posted yet for this study

Summary

Healthcare associated infections linked to the use of indwelling medical devices increase hospital morbidity, mortality and the Intensive Care treatment costs. The essential strategy for mitigating these consequences are prompt source identifcation and control, with appropriate antimicrobial therapy initiation as soon as possible. Removing the source is one of the golden rule for infection control. Early identification of the responsible germs is the other major guiding element for the appropriate anti-infectious treatment.

Despite multiple detection/identification methods, there are no clear recommendations for biofilm identification in clinical practice. The gold standard method is bacterial/fungal culturing, with disadvantages related to late results, especially for slow growing, fastidious germs or related to the existence of uncultivable strains.

In order to obtain more sensitive, specific results and to increase the chances of better biofilm characterization, in the present study the investigators compare biofilm identification results obtained by standard cultivation methods with those by DNA amplification and next generation gene sequencing. The studied biofilm is associated to four criticallly ill oncological patients indwelling devices (endotracheal tube, central venous catheter, arterial catheter and urinary catheter).

Conditions

Interventions

DIAGNOSTIC_TEST

indwelling device biofilm identification

performance of the NGS-based identification technique in comparison with the conventional culture-based one, for the same indwelling device biofilm sample

Sponsors & Collaborators

  • Grigore T. Popa University of Medicine and Pharmacy

    lead OTHER

Principal Investigators

  • Luminita Smaranda Iancu, Professor · University of Medicine and Pharmacy "Grigore T Popa", Iasi, Romania

  • Ioana Grigoras, Professor · University of Medicine and Pharmacy "Grigore T Popa", Iasi, Romania

  • Olivia Simona Dorneanu, Assoc Prof · University of Medicine and Pharmacy "Grigore T Popa", Iasi, Romania

  • Catalina Lunca, Assist Prof · University of Medicine and Pharmacy "Grigore T Popa", Iasi, Romania

  • Teodora Vremera, Assist Prof · University of Medicine and Pharmacy "Grigore T Popa", Iasi, Romania

  • Stefania Brandusa Copacianu, MD, PhD · Regional Institute of Oncology Iasi, Romania

  • Iuliu Ivanov, PhD · Regional Institute of Oncology Iasi, Romania

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-05
Primary Completion
2023-09-05
Completion
2025-10-05

Countries

  • Romania

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04328818 on ClinicalTrials.gov