Critically IllPhase 1/2CRITICNCT03868241
Coated Devices to Decrease Infection in the Intensive Care Unit
A Phase 1/2 study testing Coated devices in people with Critically Ill, run by Hospital do Coracao at 6 sites in Brazil.
Trial summary
Pilot explanatory, randomized, open label, controlled trial. Critically ill patients which will demand placement of invasive devices for organ support (endotracheal tube, central venous catheter and urinary Foley catheter) will be randomized 1:1 to receive coated (Bactiguard®) or habitual (non-coated) devices. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Critically Ill
- What is being tested?
- Coated devices
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 6 sitesBrazil
- Study dates
- 6 Apr 2019to 28 Feb 2020
- Phase
- Phase 1/2
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients admitted to the intensive care unit which will require simultaneous insertion of all three devices (endotracheal tube, central venous catheter and urinary catheter) due to illness severity as defined by the attending physician.
Who cannot join
- Patients admitted to the intensive care unit for more than 48 hours or admitted in the hospital for more than seven days
- Presence of any of the invasive devices (endotracheal tube, central venous catheter or urinary catheters) before randomization and absence of the intention to exchange the devices;
- Previous use of any type of coated devices;
- Age < 18 years;
- Known pregnancy
- Known allergy to gold, silver and palladium;
Show all 11Show fewer
- Suspected or confirmed brain death;
- Previously enrolled in the study
- Newly added exclusion criteria in version 2.0:
- Severe chronic pulmonary obstructive disease which may limit catheter site selection
- Previous irradiation and/or thrombosis in site selected for catheter insertion
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Brazil6 sites
Hospital de Base de São José do Rio Preto
Rio Preto, São Paulo
Hospital do Coração
São Paulo, São Paulo, 04005000
AC Camargo Câncer Center
São Paulo
Hospital da Luz
São Paulo
Hospital Paulistano
São Paulo
Hospital São Paulo - UNIFESP
São Paulo
About this study
Official title: Randomized Controlled Open-label Trial Assessing the Efficacy of a Bundle of Coated Devices to Reduce Nosocomial Infections in the Intensive Care Unit
Pilot explanatory, randomized, open label, controlled trial. Critically ill patients which will demand placement of invasive devices for organ support (endotracheal tube, central venous catheter and urinary Foley catheter) will be randomized 1:1 to receive coated (Bactiguard®) or habitual (non-coated) devices.
- Conditions
- Critically Ill
- Being tested
- Coated devices, Control
- Keywords
- sepsis, ventilator-associated pneumonia, catheter related bloodstream infection, urinary catheter-related infection
- Medical subject headings
- Critical Illness, Sepsis, Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coated devicesDevice
Gold-silver-palladium coated devices (endotracheal tube, central venous catheter and urinary catheter) will be used whenever necessary. All three devices are required to be inserted as soon as possible after randomization and need for all three devices are the main inclusion criteria
ControlDevice
Devices without coating available at each participating intensive care unit
| Study group | Role | What they receive |
|---|---|---|
| Bactiguard-coated Devices | Experimental | Patients will receive endotracheal tube, central venous catheter and urinary cather coated with gold, silver and palladium (Bactiguard coating) Receives: Device: Coated devices |
| Control | Placebo comparator | Shelf endotracheal tube, central venous catheter and urinary cather available at each intensive care unit without any type of coating designed to prevent infection Receives: Device: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants recruited in each center during the trial
Assess the recruitment rate
Measured: Through study completion, an average of 1 year
Number of participants admitted to the intensive care unit that requires simultaneous insertion of endotracheal tube, central venous catheter and urinary catheter
Assess how many patients admitted to the intensive care unit will demand insertion of endotracheal tube, urinary catheter and central venous catheter after admission in all patients
Measured: Through study completion, an average of 1 year
Feasibility - Occurence of sepsis
Occurrence of sepsis after admission in patients that require all three devices to be inserted in all patients
Measured: 28 days
Secondary outcomes (8)
Sepsis
Occurrence of sepsis after randomization (defined as infection plus organ failure)
Measured: 28 days
Occurence of ventilator-associated pneumonia
Occurence of ventilator-associated pneumonia by radiographic and clinical criteria
Measured: 28 days
Occurence of central venous catheter-related bloodstream infection
Occurence of central venous catheter-related bloodstream infection using Brazilian regulatory agency criteria
Measured: 28 days
Occurence of urinary catheter-related infection
Occurence of urinary catheter-related infection defined as positive urinary culture coupled with fever and without any other infection source
Measured: 28 days
Rate of composite endpoint of ventilator-associated pneumonia and/or central venous catheter-related bloodstream infection and/or urinary catheter-related infection
Occurrence of any of the infections above
Measured: 28 days
Antibiotic-free days
Number of days not receiving antibiotics
Measured: 28 days
Number of patients that die in Intensive Care Unit
Mortality during intensive care unit stay
Measured: Through intensive care unit stay, an average of 28 days
Number of patients that die during hospital stay
Mortality during hospital stay
Measured: Through hospital stay, an average of 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start6 Apr 2019
- Primary completion13 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critically IllStudies 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital do Coracao
- Sponsor type
- University, hospital or other
- Collaborators
- Bactiguard AB
- Responsible party
- Sponsor
- Investigators
- Alexandre Biasi, MD/PhD, Study director, Hospital do Coração
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03868241
- Sponsor's protocol ID
- CRITIC_PILOT
- Acronym
- CRITIC
- Status last verified
- Mar 2020
- First submitted
- 6 Mar 2019
- Last updated
- 9 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zampieri FG, de Oliveira NE, Nassar AP Jr, de Oliveira Manoel AL, Grion C, Lacerda FH, Maia I, Thompson M, Giancursi TS, de Aquino Martins P, Lisboa T, Abait T, Damiani LP, Machado FR, Cavalcanti AB; BRICNet. Bundle of Coated Devices to Reduce Nosocomial Infections in the Intensive Care Unit. CRITIC Pilot Randomized Controlled Trial. Ann Am Thorac Soc. 2020 Oct;17(10):1257-1263. doi: 10.1513/AnnalsATS.202003-206OC.
PubMed 32526149
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Open-label Trial Assessing the Efficacy of a Bundle of Coated Devices to Reduce Nosocomial Infections in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT03868241
- Acronym / sponsor ID
- CRITIC / CRITIC_PILOT
- Conditions
- Critically Ill
- Keywords
- sepsis, ventilator-associated pneumonia, catheter related bloodstream infection, urinary catheter-related infection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Hospital do CoracaoUniversity, hospital or other
- Collaborators
- Bactiguard AB
- Study start
- 6 Apr 2019 (actual)
- Primary completion
- 13 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 11 Mar 2019 (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.
Pilot explanatory, randomized, open label, controlled trial. Critically ill patients which will demand placement of invasive devices for organ support (endotracheal tube, central venous catheter and urinary Foley catheter) will be randomized 1:1 to receive coated (Bactiguard®) or habitual (non-coated) devices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bactiguard-coated Devices | Experimental | Device: Coated devicesPatients will receive endotracheal tube, central venous catheter and urinary cather coated with gold, silver and palladium (Bactiguard coating) |
| Control | Placebo comparator | Device: ControlShelf endotracheal tube, central venous catheter and urinary cather available at each intensive care unit without any type of coating designed to prevent infection |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients admitted to the intensive care unit which will require simultaneous insertion of all three devices (endotracheal tube, central venous catheter and urinary catheter) due to illness severity as defined by the attending physician.
Key exclusion criteria (11 listed)
- Patients admitted to the intensive care unit for more than 48 hours or admitted in the hospital for more than seven days
- Presence of any of the invasive devices (endotracheal tube, central venous catheter or urinary catheters) before randomization and absence of the intention to exchange the devices;
- Previous use of any type of coated devices;
- Age < 18 years;
- Known pregnancy
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 |
|---|---|---|
| Coated devicesGold-silver-palladium coated devices (endotracheal tube, central venous catheter and urinary catheter) will be used whenever necessary. All three devices are required to be inserted as soon as possible after randomization and need for all three devices are the main inclusion criteria | Device | Bactiguard-coated Devices |
| ControlDevices without coating available at each participating intensive care unit | Device | Control |
Primary outcome
Number of participants recruited in each center during the trial
Time frame: Through study completion, an average of 1 year
Assess the recruitment rate
Number of participants admitted to the intensive care unit that requires simultaneous insertion of endotracheal tube, central venous catheter and urinary catheter
Time frame: Through study completion, an average of 1 year
Assess how many patients admitted to the intensive care unit will demand insertion of endotracheal tube, urinary catheter and central venous catheter after admission in all patients
Feasibility - Occurence of sepsis
Time frame: 28 days
Occurrence of sepsis after admission in patients that require all three devices to be inserted in all patients
8 secondary outcomes
Sepsis
Time frame: 28 days
Occurence of ventilator-associated pneumonia
Time frame: 28 days
Occurence of central venous catheter-related bloodstream infection
Time frame: 28 days
Occurence of urinary catheter-related infection
Time frame: 28 days
Rate of composite endpoint of ventilator-associated pneumonia and/or central venous catheter-related bloodstream infection and/or urinary catheter-related infection
Time frame: 28 days
Antibiotic-free days
Time frame: 28 days
Number of patients that die in Intensive Care Unit
Time frame: Through intensive care unit stay, an average of 28 days
Number of patients that die during hospital stay
Time frame: Through hospital stay, an average of 40 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2020.
- Derived from this study: PubMed 32526149Zampieri FG, de Oliveira NE, Nassar AP Jr, de Oliveira Manoel AL, Grion C, Lacerda FH, Maia I, Thompson M, Giancursi TS, de Aquino Martins P, Lisboa T, Abait T, Damiani LP, Machado FR, Cavalcanti AB; BRICNet. Bundle of Coated Devices to Reduce Nosocomial Infections in the Intensive Care Unit. CRITIC Pilot Randomized Controlled Trial. Ann Am Thorac Soc. 2020 Oct;17(10):1257-1263. doi: 10.1513/AnnalsATS.202003-206OC.
- Individual participant dataSharing planned: No
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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.
Alexandre Biasi, MD/PhD study director
Hospital do Coração
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Coated devices in people with Critically Ill, run by Hospital do Coracao at 6 sites in Brazil.
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 1 inclusion and 11 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: finished, as of the sponsor's last update on 9 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Brazil. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants recruited in each center during the trial (time frame: Through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03868241, which also lists 1 linked publication.
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 9 Mar 2020.