Indwelling Device-associated Biofilms
NCT04328818 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 150
Last updated 2022-03-16
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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