Clinical trial · Observational
Indwelling Device-associated Biofilms
Indwelling Device-associated Biofilms in Oncological Critically Ill Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Critical Illness | — | UNRESOLVED | — |
| Hospital Infection | — | UNRESOLVED | — |
| Oncology | — | UNRESOLVED | — |
| Sepsis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| indwelling device biofilm identification | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The detection/identification of biofilm-associated pathogens
- timeFrame
- through study completion, an average of 1 year
- description
- The detection/identification of biofilm-associated pathogens using Next Generation Sequencing (NGS) technique compared with standard microbiological diagnosis.
Secondary outcomes (4)
- measure
- Identification of pathogens involved in ID biofilm formation
- timeFrame
- through study completion, an average of 1 year
- description
- Identification of pathogens involved in ID biofilm formation (ET, CVC, AC, UC) in the critically ill oncological patients.
- measure
- Comparison of the biofilm-associated pathogens with those identified in currently used biological samples
- timeFrame
- through study completion, an average of 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: 1. Signed informed consent; 2. Age ≥18 years; 3. Suspected/proven sepsis/septic shock (Supplemental file 2); 4. APACHE II score ≥10 (Supplemental file 3); 5. Predictable invasive ventilatory support ≥ 48 hours; 6. Patient estimated survival ≥ 4 days. Exclusion criteria: 1. Patient/legal representative refusal; 2. Age \<18 years; 3. Chronic psychiatric/neurological disease with impaired decision-making capacity; 4. Pregnancy; 5. Invasive ventilatory support \< 2 days; 6. Death in less than 4 days after ICU admission.
References
Publications (0)
Data not yet available