Infection PreventionPhase 4NCT00370149
Study of Catheter-related Infections Using Antibiotic-coated Versus Conventional Catheters in Children
A Phase 4 study testing Antibiotic-impregnated Catheters (M/R) and Non-impregnated Catheters (C/S) in people with Infection Prevention, run by Indiana University at 1 site in United States.
Trial summary
The primary purpose of the study is to determine if a therapeutic difference exists between central venous catheters impregnated with minocycline and rifampin and conventional catheters not impregnated with antibiotics when used in children at high risk for bloodstream infections (CABSI) after cardiac surgery. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Infection Prevention
- What is being tested?
- Antibiotic-impregnated Catheters (M/R) and Non-impregnated Catheters (C/S)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 326 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to May 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age < 18 years
- Cardiovascular surgery patient with a case complexity warranting CVC placement longer than 3 days
- Study devices of appropriate size for patient use without modification
- Informed consent obtained prior to patient entering the operating room
Who cannot join
- Age ≥ 18 years
- Drug allergy to minocycline, other tetracyclines, or rifampin
- Ventricular assist device (VAD) therapy
- Extracorporeal membrane oxygenation (ECMO) therapy
- Patients undergoing cardiac transplant
- Any active infection or being treated for bacteremia at the time of randomization
Trial locations and contacts
1 site in 1 country.
United States1 site
Riley Hospital for Children
Indianapolis, Indiana, 46202
About this study
Official title: A Randomized, Controlled Trial of Catheter Related Infectious Event Rates Using Antibiotic-impregnated Catheters vs. Conventional Catheters in Pediatric Cardiovascular Surgery Patients
The primary purpose of the study is to determine if a therapeutic difference exists between central venous catheters impregnated with minocycline and rifampin and conventional catheters not impregnated with antibiotics when used in children at high risk for bloodstream infections (CABSI) after cardiac surgery.
Read the detailed description
The standard central venous catheter (CVC) is now commonly used for infants, children, and adults. The antibiotic-coated CVC is a newer CVC gaining popularity for use in adults. The Food and Drug Administration (FDA) and the Center for Disease Control (CDC) support use of the antibiotic-coated CVC for adult patients. But the FDA and CDC have not yet endorsed use of the antibiotic-coated CVC for infants and children due to lack of research on this CVC in infants and children.
- Conditions
- Infection Prevention
- Being tested
- Antibiotic-impregnated Catheters (M/R), Non-impregnated Catheters (C/S)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotic-impregnated Catheters (M/R)Device
Patients randomized to this arm will have the antibiotic-impregnated catheters inserted intra-operatively. The catheters are sized to accommodate children in different size ranges.
Non-impregnated Catheters (C/S)Device
Patients randomized to this arm will have the central venous catheter inserted intra-operatively. The catheters are sized to accommodate children in different size ranges.
| Study group | Role | What they receive |
|---|---|---|
| Antibiotic-impregnated Catheters (M/R) | Active comparator | Interventions is insertion intra-operatively of catheters impregnated with minocycline and rifampin to determine if their is a therapeutic difference between this catheter and the placebo (non-impregnated) catheter. The catheters are sized to accommodate children in different size ranges: Cook Inc. Double Lumen 4 Fr., 8 cm long, (C-UDLM-401J-ABRM-HC), 5 Fr., 8 cm long, (C-UDLM-501J-ABRM-HC), and 5 Fr., 12 cm long, (C-UDLMY-501J-RSC-ABRM-HC). Receives: Device: Antibiotic-impregnated Catheters (M/R) |
| Non-impregnated Catheter (C/S) | Placebo comparator | Intervention is insertion intra-operatively of conventional, non-impregnated catheters. There are two sizes to accommodate children in different size ranges: Cook Incorporated Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J), 5 Fr., 8 cm long, (C-UDLM-501J), and 5 Fr., 12 cm long (C-UDLM-501J-RSC). Receives: Device: Non-impregnated Catheters (C/S) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Catheter-related Bloodstream Infections (CRBSI) Per 1000 Catheter Days
Rates of CRBSI defined as 1. micro-organism isolated from a blood culture; 2. Clinical manifestations of infection such as fever (≥38 C) and/or hypotension (defined according to age-related practice guidelines for systolic blood pressure); 3. No apparent source for the bloodstream infection except for the catheter.
Measured: Participants were followed for the duration of the hospital stay, an average of 6 days.
Secondary outcomes (2)
Episodes of Clinical Sepsis and/or Infection With Identified Source Other Than Catheter
A secondary outcome measure was episodes of clinical sepsis and/or infection with identified source other than the CVC.
Measured: Participants were followed for the duration of hospital stay, an average of 6 days.
Death
Patient Death during hospitalization.
Measured: Participants were followed for the duration of the hospital stay, an average of 6 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2006 (estimated)
- Study startSep 2006
- Primary completionMay 2010
- Study completionMay 2010
Why it stopped: Blinded interim analysis resulted in early termination of the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infection PreventionStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elaine G. Cox, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00370149
- Sponsor's protocol ID
- 0512-37
- Status last verified
- Jan 2016
- First submitted
- 28 Aug 2006
- Last updated
- 24 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Cox EG, Knoderer CA, Jennings A, Brown JW, Rodefeld MD, Walker SG, Turrentine MW. A Randomized, Controlled Trial of Catheter-Related Infectious Event Rates Using Antibiotic-Impregnated Catheters Versus Conventional Catheters in Pediatric Cardiovascular Surgery Patients. J Pediatric Infect Dis Soc. 2013 Mar;2(1):67-70. doi: 10.1093/jpids/pis066. Epub 2012 Jul 4.
PubMed 26619445
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial of Catheter Related Infectious Event Rates Using Antibiotic-impregnated Catheters vs. Conventional Catheters in Pediatric Cardiovascular Surgery Patients
- ClinicalTrials.gov ID
- NCT00370149
- Acronym / sponsor ID
- 0512-37
- Conditions
- Infection Prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Blinded interim analysis resulted in early termination of the study.
- Enrolment
- 326 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 30 Aug 2006 (estimated)
- Results
- Posted 24 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of the study is to determine if a therapeutic difference exists between central venous catheters impregnated with minocycline and rifampin and conventional catheters not impregnated with antibiotics when used in children at high risk for bloodstream infections (CABSI) after cardiac surgery.
Detailed description
The standard central venous catheter (CVC) is now commonly used for infants, children, and adults. The antibiotic-coated CVC is a newer CVC gaining popularity for use in adults. The Food and Drug Administration (FDA) and the Center for Disease Control (CDC) support use of the antibiotic-coated CVC for adult patients. But the FDA and CDC have not yet endorsed use of the antibiotic-coated CVC for infants and children due to lack of research on this CVC in infants and children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotic-impregnated Catheters (M/R) | Active comparator | Device: Antibiotic-impregnated Catheters (M/R)Interventions is insertion intra-operatively of catheters impregnated with minocycline and rifampin to determine if their is a therapeutic difference between this catheter and the placebo (non-impregnated) catheter. The catheters are sized to accommodate children in different size ranges: Cook Inc. Double Lumen 4 Fr., 8 cm long, (C-UDLM-401J-ABRM-HC), 5 Fr., 8 cm long, (C-UDLM-501J-ABRM-HC), and 5 Fr., 12 cm long, (C-UDLMY-501J-RSC-ABRM-HC). |
| Non-impregnated Catheter (C/S) | Placebo comparator | Device: Non-impregnated Catheters (C/S)Intervention is insertion intra-operatively of conventional, non-impregnated catheters. There are two sizes to accommodate children in different size ranges: Cook Incorporated Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J), 5 Fr., 8 cm long, (C-UDLM-501J), and 5 Fr., 12 cm long (C-UDLM-501J-RSC). |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age < 18 years
- Cardiovascular surgery patient with a case complexity warranting CVC placement longer than 3 days
- Study devices of appropriate size for patient use without modification
- Informed consent obtained prior to patient entering the operating room
Key exclusion criteria (6 listed)
- Age ≥ 18 years
- Drug allergy to minocycline, other tetracyclines, or rifampin
- Ventricular assist device (VAD) therapy
- Extracorporeal membrane oxygenation (ECMO) therapy
- Patients undergoing cardiac transplant
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 |
|---|---|---|
| Antibiotic-impregnated Catheters (M/R)Patients randomized to this arm will have the antibiotic-impregnated catheters inserted intra-operatively. The catheters are sized to accommodate children in different size ranges. | Device | Antibiotic-impregnated Catheters (M/R) |
| Non-impregnated Catheters (C/S)Patients randomized to this arm will have the central venous catheter inserted intra-operatively. The catheters are sized to accommodate children in different size ranges. | Device | Non-impregnated Catheter (C/S) |
Primary outcome
Incidence of Catheter-related Bloodstream Infections (CRBSI) Per 1000 Catheter Days
Time frame: Participants were followed for the duration of the hospital stay, an average of 6 days.
Rates of CRBSI defined as 1. micro-organism isolated from a blood culture; 2. Clinical manifestations of infection such as fever (≥38 C) and/or hypotension (defined according to age-related practice guidelines for systolic blood pressure); 3. No apparent source for the bloodstream infection except for the catheter.
2 secondary outcomes
Episodes of Clinical Sepsis and/or Infection With Identified Source Other Than Catheter
Time frame: Participants were followed for the duration of hospital stay, an average of 6 days.
Death
Time frame: Participants were followed for the duration of the hospital stay, an average of 6 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26619445Cox EG, Knoderer CA, Jennings A, Brown JW, Rodefeld MD, Walker SG, Turrentine MW. A Randomized, Controlled Trial of Catheter-Related Infectious Event Rates Using Antibiotic-Impregnated Catheters Versus Conventional Catheters in Pediatric Cardiovascular Surgery Patients. J Pediatric Infect Dis Soc. 2013 Mar;2(1):67-70. doi: 10.1093/jpids/pis066. Epub 2012 Jul 4.
- Riley Childrens Hospital at Indiana University HealthLink provided by the sponsor.
- 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.
Elaine G. Cox, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Antibiotic-impregnated Catheters (M/R) and Non-impregnated Catheters (C/S) in people with Infection Prevention, run by Indiana University at 1 site in United States.
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 4 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: stopped early, as of the sponsor's last update on 24 Feb 2016. 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 United States. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Catheter-related Bloodstream Infections (CRBSI) Per 1000 Catheter Days (time frame: Participants were followed for the duration of the hospital stay, an average of 6 days.). 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 NCT00370149, 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 24 Feb 2016.