Indwelling Device-associated Biofilms

NCT04328818 | Unknown

• 1 other identifier: GTPopaUMPIASI
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Oncology; Critical Illness; Sepsis; Hospital Infection

Keywords

biofilm; oncologic; critical; Next Generation Sequencing

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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

• 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

Interventions

indwelling device biofilm identification DIAGNOSTIC_TEST

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

Eligibility Criteria

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

Study Population

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.

You may qualify if:

• Signed informed consent;
• Age ≥18 years;
• Suspected/proven sepsis/septic shock (Supplemental file 2);
• APACHE II score ≥10 (Supplemental file 3);
• Predictable invasive ventilatory support ≥ 48 hours;
• Patient estimated survival ≥ 4 days.

You may not qualify if:

• Patient/legal representative refusal;
• Age \<18 years;
• Chronic psychiatric/neurological disease with impaired decision-making capacity;
• Pregnancy;
• Invasive ventilatory support \< 2 days;
• Death in less than 4 days after ICU admission.

Sponsors & Collaborators

• Grigore T. Popa University of Medicine and Pharmacy: lead

Study Sites (1)

Regional Institute of Oncology

Iași, 7--483, Romania

Location

Biospecimen

Retention: SAMPLES WITH DNA

Biofilm from four medical devices: endotracheal tube, arterial catheter, central venous catheter and urinary catheter.

MeSH Terms

Conditions

Neoplasms; Critical Illness; Sepsis; Cross Infection

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Iatrogenic Disease

Study Officials

• Luminita Smaranda Iancu, Professor

  University of Medicine and Pharmacy "Grigore T Popa", Iasi, Romania

  PRINCIPAL INVESTIGATOR

• Ioana Grigoras, Professor

  University of Medicine and Pharmacy "Grigore T Popa", Iasi, Romania

  STUDY DIRECTOR

• Olivia Simona Dorneanu, Assoc Prof

  University of Medicine and Pharmacy "Grigore T Popa", Iasi, Romania

  STUDY DIRECTOR

• Catalina Lunca, Assist Prof

  University of Medicine and Pharmacy "Grigore T Popa", Iasi, Romania

  STUDY DIRECTOR

• Teodora Vremera, Assist Prof

  University of Medicine and Pharmacy "Grigore T Popa", Iasi, Romania

  STUDY CHAIR

• Stefania Brandusa Copacianu, MD, PhD

  Regional Institute of Oncology, Iasi, Romania

  STUDY CHAIR

• Iuliu Ivanov, PhD

  Regional Institute of Oncology, Iasi, Romania

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer, MD

Study Record Dates

• First Submitted: March 27, 2020
• First Posted: March 31, 2020
• Study Start: June 5, 2019
• Primary Completion: September 5, 2023
• Study Completion: October 5, 2025
• Last Updated: March 16, 2022

Record last verified: 2022-03

Locations

RO (1)