Study of Catheter-related Infections Using Antibiotic-coated Versus Conventional Catheters in Children
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|ClinicalTrials.gov Identifier: NCT00370149|
Recruitment Status : Terminated (Blinded interim analysis resulted in early termination of the study.)
First Posted : August 30, 2006
Results First Posted : February 24, 2016
Last Update Posted : February 24, 2016
|Condition or disease||Intervention/treatment||Phase|
|Infection Prevention||Device: Antibiotic-impregnated Catheters (M/R) Device: Non-impregnated Catheters (C/S)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||326 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Controlled Trial of Catheter Related Infectious Event Rates Using Antibiotic-impregnated Catheters vs. Conventional Catheters in Pediatric Cardiovascular Surgery Patients|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||May 2010|
Active Comparator: 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).
Device: 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.
Placebo Comparator: Non-impregnated Catheter (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).
Device: 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.
- 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.
- 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. ]A secondary outcome measure was episodes of clinical sepsis and/or infection with identified source other than the CVC.
- Death [ Time Frame: Participants were followed for the duration of the hospital stay, an average of 6 days. ]Patient Death during hospitalization.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00370149
|United States, Indiana|
|Riley Hospital for Children|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Elaine G. Cox, MD||Indiana University School of Medicine|