OncologyBiofilmICUNCT04328818
Indwelling Device-associated Biofilms
An observational study of Oncology and Critical Illness, run by Grigore T. Popa University of Medicine and Pharmacy at 1 site in Romania.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncology, Critical Illness, Sepsis
- What is being tested?
- indwelling device biofilm identification
- How many people
- 150 participants
- Where
- 1 siteRomania
- Study dates
- 5 Jun 2019to 5 Oct 2025
- How long will I take part?
- 28 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Indwelling Device-associated Biofilms in Oncological Critically Ill Patients
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).
Read the detailed description
According to Regional Institute of Oncology, Iasi protocols, all septic patients with the need of invasive ventilatory support (endotracheal intubation), have concomitantly inserted a CVC, an AC and a UC, as standard of care. All patients undergo the protocol for the management of suspected/proven sepsis: initial resuscitation, specimen collection for microbiology/molecular biology tests, empirical/targeted anti-infectious treatment, source control, multiple organ support and treatment of the underlying disease/comorbidities. All RIO patients are screened for nasal, pharyngeal and rectal pathogen colonization at the time of hospital/ICU admission.
Informed consent - During the first 24 hours of ICU admission, all eligible patients will receive written information about the study: its implementation, aims, expected advantages and possible risks, and they will be asked to sign an informed consent. If the patient is unable to give consent at ICU admission due to pathological or drug-induced acute alteration of consciousness, a legal representative may give authorization. Once the participant regains the decision capacity, the individual will be asked to confirm or withdraw consent.
Swab sampling - The nasal, pharyngeal and rectal screening swab sampling is collected according to standard methods. In addition to this standard screening, in the first 24 hours of ICU admission cutaneous samples from the groin area of enrolled patients will be obtained, with sterile Copan eSwabTM swabs, a product recommended for aerobic, anaerobic and fastidious microbial agents.
Biofilm sampling and transport - The extraction of the four ID (ET, CVC, AC, UC) will be performed when the clinical condition of the patient dictates it (suspected catheter infection/no further need due to improvement or death). These devices will be extracted by medical ICU personnel, only at the indication and according to the medical judgment of the clinician, without being influenced by the patient's study participation.
Microbiological processing and analysis of the biofilm - Microbiological analysis will be performed by standard method: sample seeding on standard culture media, then biochemical identification test and AST according to CLSI standards and guidelines using MicroScan Walk Away 40 plus®, Beckmann Coulter automatic system compatible pannels.
Molecular biology processing and analysis of the biofilm - After complete sample collection, gene sequencing of the variable regions V3-V4 16S rRNA gene will be performed using Illumina MiSeq® Next Generation Sequencer System.
- Conditions
- Oncology, Critical Illness, Sepsis, Hospital Infection
- Being tested
- indwelling device biofilm identification
- Keywords
- biofilm, oncologic, critical, Next Generation Sequencing
- Medical subject headings
- Neoplasms, Critical Illness, Sepsis, Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
indwelling device biofilm identificationDiagnostic test
performance of the NGS-based identification technique in comparison with the conventional culture-based one, for the same indwelling device biofilm sample
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
Identification of pathogens involved in ID biofilm formation
Identification of pathogens involved in ID biofilm formation (ET, CVC, AC, UC) in the critically ill oncological patients.
Measured: through study completion, an average of 1 year
Comparison of the biofilm-associated pathogens with those identified in currently used biological samples
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.
Measured: 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.
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.
Measured: through study completion, an average of 1 year
Establishing clinico-biological correlations
Correlations between biofilm-associated pathogens and patient clinico-biological data:
- nasal, pharyngeal, rectal and skin pathogen screening;
- associated risk factors: neutropenia, chemo/radiotherapy, corticosteroid treatment, previous anti-infectious therapy;
- ID exposure time;
- biological markers of inflammation;
- diagnosed infection: respiratory tract infection, urinary tract infection, bloodstream infection, surgical site infection, sepsis of unknown origin, etc.;
- severity scores: Sequential [Sepsis-Related] Organ Failure Assessment (SOFA) score, Acute Physiology and Chronic Health Evaluation II (APACHE II) score;
- ICU and hospital LOS;
- patient's outcome: survival/death;
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start5 Jun 2019
- Primary completion5 Sep 2023 (estimated)
- Study completion5 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Grigore T. Popa University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olguta Lungu, Grigore T. Popa University of Medicine and Pharmacy
- Investigators
- Luminita Smaranda Iancu, Professor, Principal investigator, University of Medicine and Pharmacy "Grigore T Popa", Iasi, RomaniaIoana Grigoras, Professor, Study director, University of Medicine and Pharmacy "Grigore T Popa", Iasi, RomaniaOlivia Simona Dorneanu, Assoc Prof, Study director, University of Medicine and Pharmacy "Grigore T Popa", Iasi, RomaniaCatalina Lunca, Assist Prof, Study director, University of Medicine and Pharmacy "Grigore T Popa", Iasi, RomaniaTeodora Vremera, Assist Prof, Study chair, University of Medicine and Pharmacy "Grigore T Popa", Iasi, RomaniaStefania Brandusa Copacianu, MD, PhD, Study chair, Regional Institute of Oncology, Iasi, RomaniaIuliu Ivanov, PhD, Study chair, Regional Institute of Oncology, Iasi, Romania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04328818
- Sponsor's protocol ID
- GTPopaUMPIASI
- Acronym
- BiofilmICU
- Status last verified
- Mar 2022
- First submitted
- 27 Mar 2020
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Patient report form, patient microbiological study sheet, patient device study sheet.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indwelling Device-associated Biofilms in Oncological Critically Ill Patients
- ClinicalTrials.gov ID
- NCT04328818
- Acronym / sponsor ID
- BiofilmICU / GTPopaUMPIASI
- Conditions
- Oncology, Critical Illness, Sepsis, Hospital Infection
- Keywords
- biofilm, oncologic, critical, Next Generation Sequencing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Grigore T. Popa University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 5 Jun 2019 (actual)
- Primary completion
- 5 Sep 2023 (estimated)
- Study completion
- 5 Oct 2025 (estimated)
- First posted
- 31 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
According to Regional Institute of Oncology, Iasi protocols, all septic patients with the need of invasive ventilatory support (endotracheal intubation), have concomitantly inserted a CVC, an AC and a UC, as standard of care. All patients undergo the protocol for the management of suspected/proven sepsis: initial resuscitation, specimen collection for microbiology/molecular biology tests, empirical/targeted anti-infectious treatment, source control, multiple organ support and treatment of the underlying disease/comorbidities. All RIO patients are screened for nasal, pharyngeal and rectal pathogen colonization at the time of hospital/ICU admission.
Informed consent - During the first 24 hours of ICU admission, all eligible patients will receive written information about the study: its implementation, aims, expected advantages and possible risks, and they will be asked to sign an informed consent. If the patient is unable to give consent at ICU admission due to pathological or drug-induced acute alteration of consciousness, a legal representative may give authorization. Once the participant regains the decision capacity, the individual will be asked to confirm or withdraw consent.
Swab sampling - The nasal, pharyngeal and rectal screening swab sampling is collected according to standard methods. In addition to this standard screening, in the first 24 hours of ICU admission cutaneous samples from the groin area of enrolled patients will be obtained, with sterile Copan eSwabTM swabs, a product recommended for aerobic, anaerobic and fastidious microbial agents.
Biofilm sampling and transport - The extraction of the four ID (ET, CVC, AC, UC) will be performed when the clinical condition of the patient dictates it (suspected catheter infection/no further need due to improvement or death). These devices will be extracted by medical ICU personnel, only at the indication and according to the medical judgment of the clinician, without being influenced by the patient's study participation.
Microbiological processing and analysis of the biofilm - Microbiological analysis will be performed by standard method: sample seeding on standard culture media, then biochemical identification test and AST according to CLSI standards and guidelines using MicroScan Walk Away 40 plus®, Beckmann Coulter automatic system compatible pannels.
Molecular biology processing and analysis of the biofilm - After complete sample collection, gene sequencing of the variable regions V3-V4 16S rRNA gene will be performed using Illumina MiSeq® Next Generation Sequencer System.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (6 listed)
- Patient/legal representative refusal;
- Age <18 years;
- Chronic psychiatric/neurological disease with impaired decision-making capacity;
- Pregnancy;
- Invasive ventilatory support < 2 days;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| indwelling device biofilm identificationperformance of the NGS-based identification technique in comparison with the conventional culture-based one, for the same indwelling device biofilm sample | Diagnostic test | – |
Primary outcome
The detection/identification of biofilm-associated pathogens
Time frame: through study completion, an average of 1 year
The detection/identification of biofilm-associated pathogens using Next Generation Sequencing (NGS) technique compared with standard microbiological diagnosis.
4 secondary outcomes
Identification of pathogens involved in ID biofilm formation
Time frame: through study completion, an average of 1 year
Comparison of the biofilm-associated pathogens with those identified in currently used biological samples
Time frame: 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.
Time frame: through study completion, an average of 1 year
Establishing clinico-biological correlations
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Individual participant dataSharing planned: Undecided. Patient report form, patient microbiological study sheet, patient device study sheet.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luminita Smaranda Iancu, Professor principal investigator
University of Medicine and Pharmacy "Grigore T Popa", Iasi, Romania
Ioana Grigoras, Professor study director
University of Medicine and Pharmacy "Grigore T Popa", Iasi, Romania
Olivia Simona Dorneanu, Assoc Prof study director
University of Medicine and Pharmacy "Grigore T Popa", Iasi, Romania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oncology and Critical Illness, run by Grigore T. Popa University of Medicine and Pharmacy at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The detection/identification of biofilm-associated pathogens (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022; AzTrials last refreshed its copy on 30 Oct 2026.