Indwelling Device-associated Biofilms
BiofilmICU
BiofilmICU
Sponsor study identifier
observational
150
1 country
1
Study Start
June 5, 2019
Actual (reported)Primary Completion
September 5, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 5, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 5, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 5, 2019
Actual (reported)March 27, 2020
Actual (reported)March 31, 2020
Actual (reported)September 5, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 5, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The detection/identification of biofilm-associated pathogens
The detection/identification of biofilm-associated pathogens using Next Generation Sequencing (NGS) technique compared with standard microbiological diagnosis.
through study completion, an average of 1 year
Identification of pathogens involved in ID biofilm formation
through study completion, an average of 1 year
Comparison of the biofilm-associated pathogens with those identified in currently used biological samples
through study completion, an average of 1 year
performance of the NGS-based identification technique in comparison with the conventional culture-based one, for the same indwelling device biofilm sample
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
All consecutive critical oncology patients, which meet all inclusion criteria and have no exclusion criteria, admitted to the Intensive Care clinic of the Regional Oncology Institute, Iasi, Romania.
Regional Institute of Oncology
Iași, 7--483, Romania
Biofilm from four medical devices: endotracheal tube, arterial catheter, central venous catheter and urinary catheter.
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
First Submitted
March 27, 2020
First Posted
March 31, 2020
Study Start
June 5, 2019
Actual (reported)Primary Completion
September 5, 2023
Estimated (date passed)Incidence of Cereblon in Intensive Care Patients
Comparison of the biofilm-associated pathogens with those identified in currently used biological samples (tracheal aspirate/bronchoalveolar lavage, blood culture, urinary culture, surgical wound swab, etc.) collected from the same patient.
through study completion, an average of 1 year
Establishing clinico-biological correlations
through study completion, an average of 1 year
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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
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 5, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 16, 2022
Record last verified: 2022-03
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Source: ClinicalTrials.gov.
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