Catheter-Related InfectionsNCT01564615
AgION Catheter for Preventing Catheter-Related Bloodstream Infections
A study testing Umbilical catheterization (AgION ) and Umbilical catheterization (ArgyleTM) in people with Catheter-Related Infections, run by University of Florence at 1 site in Italy.
Trial summary
The investigators assessed if use of AgION-impregnated umbilical catheters can decrease the occurrence of catheter-related bloodstream infections (CRBSI) in preterm infants. Read more about this study
- Who is it for?
- Ages 1 day to 7 days
- Conditions the study is for
- Catheter-Related Infections
- What is being tested?
- Umbilical catheterization (AgION ) and Umbilical catheterization (ArgyleTM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2007to Jun 2009
- Phase
- Interventional
- 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 1 day to 7 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age < 30 weeks
- Need of an umbilical venous catheter in the first week of life
- Parental informed consent.
Who cannot join
- Major congenital malformations
- Hydrops fetalis
- Inherited congenital metabolic diseases
- Death during the first week of life
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reduction of Catheter-Related Bloodstream Infections in Preterm Infants by the Use of Catheters With the AgION Antimicrobial System
The investigators assessed if use of AgION-impregnated umbilical catheters can decrease the occurrence of catheter-related bloodstream infections (CRBSI) in preterm infants.
Read the detailed description
Recently, a silver zeolite-impregnated catheter has been commercialized. This material, namely the patented silver compound AgION™, releases antimicrobially active silver ions which may help prevent catheter-related bloodstream infections CRBSIs which are frequent in preterm infant.
The investigators hypothesized that the use of AgION-impregnated umbilical catheters could decrease the occurrence of CRBSIs in preterm infants. To assess this hypothesis the investigators carried out a randomized controlled study in which preterm infants needing an umbilical vein catheter would received either an AgION catheter or a traditional non-impregnated polyurethane catheter.
Infants with gestational age < 30 weeks were randomized to receive an AgION- impregnated or non-impregnated polyurethane umbilical venous catheter (UVC) by opening sealed opaque envelopes. The primary end point was the incidence of CRBSIs during the time the UVC was in place.
The investigators studied 86 infants, 41 of whom received the AgION catheter and 45 the non-impregnated catheter. During umbilical venous catheterization 2% of infants in the AgION group developed CRBSI in comparison with 22% of infants in the control group (p=0.005). The incidence density of CRBSIs during the study period was lower in infants who received AgION catheters compared to the control group (2.1/1000 catheter days versus 25.8/1000 catheter days; p<0.001). The occurrence of UVC colonization was similar in both groups. The Kaplan-Meier estimates of the cumulative likelihood of being free of a CRBSI at each day of UVC placement demonstrate the statistically significant (p=0.004) protective effect of AgION impregnated catheters. Moreover, infants in the AgION group had shorter hospital stay (p=0.04), and a lower case fatality rate due to BSI (p=0.01) than infants in the control group.
AgION catheters were well tolerated and none of patients showed signs attributable to silver toxicity.
Multivariate analysis demonstrated that non-impregnated catheter use (OR 12.5, 95% C.l. 2.06-75.9) and catheter placement for more than 7 days (OR 5.1, 95% C.l. 1.13-23.6) increased the risk of developing a CRBSI in our population.
Conclusions. The AgION-impregnated UVCs were effective in decreasing the development of CRBSIs in preterm infants compared to non-impregnated polyurethane UVCs.
- Conditions
- Catheter-Related Infections
- Being tested
- Umbilical catheterization (AgION ), Umbilical catheterization (ArgyleTM)
- Keywords
- Catheter related bloodstream infection, Umbilical venous catheter, Silver, Preterm infants
- Medical subject headings
- Catheter-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical catheterization (AgION )Device
Infants received a AgION impregnated catheter (4.0-5.0 F Lifecath PICC ExpertTM, Vygon, Ecouen, France).
Umbilical catheterization (ArgyleTM)Device
Infants received a polyurethane non-impregnated catheter (3.5-5.0 F ArgyleTM, Kendall, Tullamore, Iceland)
| Study group | Role | What they receive |
|---|---|---|
| AgION catheter | Experimental | Patients in this arm received an AgION impregnated catheter (4.0-5.0 F Lifecath PICC ExpertTM, Vygon, Ecouen, France). Receives: Device: Umbilical catheterization (AgION ) |
| Non-impregnated polyurethane catheter | Active comparator | Patients in this arm received a non-impregnated polyurethane umbilical catheter (3.5-5.0 F ArgyleTM, Kendall, Tullamore, Iceland) Receives: Device: Umbilical catheterization (ArgyleTM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of CRBSIs
We evaluated the incidence of CRBSIs (definite plus probable) during the time the UVC was in place.
Measured: Infants were followed for the duration the AgION umbilical venous catheter (UVC) was in place, an expected average of 10 days
Secondary outcomes (4)
Infection density
Number of infections/1000 catheter days, likelihood of freedom from CRIBSIS, and signs of catheter intolerance and possible adverse effects from silver ion toxicity were evaluated for the duration of umbilical venous catheterization; occurrence of BPD, IVH, PVL, ROP, and NEC, length of stay in hospital, case fatality rate for infants with CRBSI, and death were evaluated at discharge.
Measured: Infants were followed for the duration the AgION umbilical venous catheter (UVC) was in place, an expected average of 10 days
Likelihood of freedom from CRIBSIs
Likelihood of freedom from CRIBSIS for the duration of umbilical venous catheterization
Measured: Infants were followed for the duration the AgION umbilical venous catheter (UVC) was in place, an expected average of 10 days
AgION catheters tolerability
Signs of local intolerance, such as skin infection, were recorded. We also evaluated possible adverse effects from silver ion toxicity, such as the occurrence of argyria (blue-grey discoloration of the skin) or hepatic damage (i.e.: increase in AST/ALT enzymes).
Measured: Infants were followed for the duration the AgION umbilical venous catheter (UVC) was in place, an expected average of 10 days
Case fatality rate for infants with CRBSI
We evaluated the mortality caused by CRBSI in infants who received AgION-impregnated and non-impregnated groups.
Measured: Hospital stay duration, an expected average of 80 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2012 (estimated)
- Study startJul 2007
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter-Related InfectionsStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florence
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlo Dani, University of Florence
- Investigators
- Carlo Dani, MD, Principal investigator, Department of Surgical and Medical Critical Care, Section of Neonatology, University of Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01564615
- Sponsor's protocol ID
- 01/2012
- Status last verified
- Mar 2012
- First submitted
- 19 Mar 2012
- Last updated
- 28 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Catheter-Related Bloodstream Infections in Preterm Infants by the Use of Catheters With the AgION Antimicrobial System
- ClinicalTrials.gov ID
- NCT01564615
- Acronym / sponsor ID
- 01/2012
- Conditions
- Catheter-Related Infections
- Keywords
- Catheter related bloodstream infection, Umbilical venous catheter, Silver, Preterm infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 28 Mar 2012 (estimated)
- 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.
The investigators assessed if use of AgION-impregnated umbilical catheters can decrease the occurrence of catheter-related bloodstream infections (CRBSI) in preterm infants.
Detailed description
Recently, a silver zeolite-impregnated catheter has been commercialized. This material, namely the patented silver compound AgION™, releases antimicrobially active silver ions which may help prevent catheter-related bloodstream infections CRBSIs which are frequent in preterm infant.
The investigators hypothesized that the use of AgION-impregnated umbilical catheters could decrease the occurrence of CRBSIs in preterm infants. To assess this hypothesis the investigators carried out a randomized controlled study in which preterm infants needing an umbilical vein catheter would received either an AgION catheter or a traditional non-impregnated polyurethane catheter.
Infants with gestational age < 30 weeks were randomized to receive an AgION- impregnated or non-impregnated polyurethane umbilical venous catheter (UVC) by opening sealed opaque envelopes. The primary end point was the incidence of CRBSIs during the time the UVC was in place.
The investigators studied 86 infants, 41 of whom received the AgION catheter and 45 the non-impregnated catheter. During umbilical venous catheterization 2% of infants in the AgION group developed CRBSI in comparison with 22% of infants in the control group (p=0.005). The incidence density of CRBSIs during the study period was lower in infants who received AgION catheters compared to the control group (2.1/1000 catheter days versus 25.8/1000 catheter days; p<0.001). The occurrence of UVC colonization was similar in both groups. The Kaplan-Meier estimates of the cumulative likelihood of being free of a CRBSI at each day of UVC placement demonstrate the statistically significant (p=0.004) protective effect of AgION impregnated catheters. Moreover, infants in the AgION group had shorter hospital stay (p=0.04), and a lower case fatality rate due to BSI (p=0.01) than infants in the control group.
AgION catheters were well tolerated and none of patients showed signs attributable to silver toxicity.
Multivariate analysis demonstrated that non-impregnated catheter use (OR 12.5, 95% C.l. 2.06-75.9) and catheter placement for more than 7 days (OR 5.1, 95% C.l. 1.13-23.6) increased the risk of developing a CRBSI in our population.
Conclusions. The AgION-impregnated UVCs were effective in decreasing the development of CRBSIs in preterm infants compared to non-impregnated polyurethane UVCs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AgION catheter | Experimental | Device: Umbilical catheterization (AgION )Patients in this arm received an AgION impregnated catheter (4.0-5.0 F Lifecath PICC ExpertTM, Vygon, Ecouen, France). |
| Non-impregnated polyurethane catheter | Active comparator | Device: Umbilical catheterization (ArgyleTM)Patients in this arm received a non-impregnated polyurethane umbilical catheter (3.5-5.0 F ArgyleTM, Kendall, Tullamore, Iceland) |
Who may qualify
- Ages
- 1 day to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Gestational age < 30 weeks
- Need of an umbilical venous catheter in the first week of life
- Parental informed consent.
Key exclusion criteria (4 listed)
- Major congenital malformations
- Hydrops fetalis
- Inherited congenital metabolic diseases
- Death during the first week of life
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 |
|---|---|---|
| Umbilical catheterization (AgION )Infants received a AgION impregnated catheter (4.0-5.0 F Lifecath PICC ExpertTM, Vygon, Ecouen, France). | Device | AgION catheter |
| Umbilical catheterization (ArgyleTM)Infants received a polyurethane non-impregnated catheter (3.5-5.0 F ArgyleTM, Kendall, Tullamore, Iceland) | Device | Non-impregnated polyurethane catheter |
Primary outcome
Incidence of CRBSIs
Time frame: Infants were followed for the duration the AgION umbilical venous catheter (UVC) was in place, an expected average of 10 days
We evaluated the incidence of CRBSIs (definite plus probable) during the time the UVC was in place.
4 secondary outcomes
Infection density
Time frame: Infants were followed for the duration the AgION umbilical venous catheter (UVC) was in place, an expected average of 10 days
Likelihood of freedom from CRIBSIs
Time frame: Infants were followed for the duration the AgION umbilical venous catheter (UVC) was in place, an expected average of 10 days
AgION catheters tolerability
Time frame: Infants were followed for the duration the AgION umbilical venous catheter (UVC) was in place, an expected average of 10 days
Case fatality rate for infants with CRBSI
Time frame: Hospital stay duration, an expected average of 80 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 28 Mar 2012.
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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.
Carlo Dani, MD principal investigator
Department of Surgical and Medical Critical Care, Section of Neonatology, University of Florence
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Umbilical catheterization (AgION ) and Umbilical catheterization (ArgyleTM) in people with Catheter-Related Infections, run by University of Florence at 1 site in Italy.
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 3 inclusion and 4 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 28 Mar 2012. 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 Italy. 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?
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?
Incidence of CRBSIs (time frame: Infants were followed for the duration the AgION umbilical venous catheter (UVC) was in place, an expected average of 10 days). 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 28 Mar 2012.