The natural history of carbapenemase-producing Enterobacterales: progression from carriage of various carbapenemases to bloodstream infection.

BACKGROUND: Little is known about the risk of progression from carbapenemase-producing Enterobacterales (CPE) carriage to CPE bloodstream infection (BSI) outside of high-risk settings. We aimed to determine the incidence of CPE BSI among CPE carriers and to assess whether the incidence differed by carbapenemase, species, and setting. METHODS: We conducted a nationwide population-based retrospective cohort study using national databases. The cohort consisted of all patients in Israel with CPE detected by screening from 1/1/2020 to 10/10/2022. We calculated the cumulative incidence of CPE BSI within 1 year among CPE carriers. We used a competing-risks model with BSI as the outcome and death as the competing risk. RESULTS: The study included 6,828 CPE carriers. The cumulative incidence of CPE BSI was 2.4% (95% CI: 2.1%-2.8%). Compared to KPC, the subhazard of BSI was lower for NDM (aSHR: 0.72, 95% CI: 0.49-1.05) and OXA-48-like (aSHR: 0.60, 95% CI: 0.32-1.12) but these differences did not reach statistical significance. Compared to K. pneumoniae, the subhazard of BSI was lower for carriers of carbapenemase-producing E. coli (aSHR: 0.31, 95% CI: 0.20-0.47). The subhazard of BSI was higher among patients with CPE carriage first detected in intensive care units (aSHR: 2.42, 95% CI: 1.50-3.92) or oncology/hematology wards (aSHR: 3.77, 95% CI: 2.40-5.93) compared to medical wards. CONCLUSIONS: The risk of CPE BSI among CPE carriers is lower than previously reported in studies that focused on high-risk patients and settings. The risk of BSI differs significantly by bacterial species and setting, but not by carbapenemase.

Impact of intensified prevention measures on rates of hospital-acquired bloodstream infection in medical-surgical intensive care units, Israel, 2011 to 2019.

BackgroundCentral line-associated bloodstream infection (CLABSI) is among the most common preventable infectious complications in patients in intensive care units (ICU). In 2011, the Israel National Center for Infection Control initiated a nationwide CLABSI prevention programme.AimTo evaluate the impact of different components of the programme on CLABSI and non-CLABSI rates in medical-surgical ICUs.MethodsWe included data collected from all 29 medical-surgical ICUs in Israel from November 2011 to December 2019. The study period was divided into three phases: I (baseline, initial CLABSI prevention guidelines introduced, initial feedback on rates provided), II (initial guidelines widely implemented, surveillance undertaken, feedback continued) and III (after implementation of additional prevention measures). Interrupted time series analysis was used to compare CLABSI and non-CLABSI rates during the three phases.ResultsThe pooled mean (SD) incidence of CLABSI per 1,000 central line-days dropped from 7.4 (0.38) in phase I to 2.1 (0.13) in phase III (p < 0.001). The incidence rate ratio (IRR) was 0.63 (95% CI: 0.51-0.79) between phases I and II, and 0.78 (95% CI: 0.59-1.02) between phases II and III. The pooled mean (SD) incidence of non-CLABSI per 1,000 patient-days declined from 5.3 (0.24) in phase I to 3.4 (0.13) in phase III (p < 0.001).ConclusionNational CLABSI prevention guidelines, surveillance and feedback resulted in significant reductions in CLABSI and non-CLABSI rates. In the wake of further interventions, significant reduction was achieved in ICUs reporting improvement in the uptake of additional prevention measures.

Pandora's box in the dental clinic.

BACKGROUND: In June 2018, the Ministry of Health received notification from 2 hospitals about 2 patients who presented with overwhelming Enterobacter kobei sepsis that developed within 24 hours after a dental procedure. We describe the investigation of this outbreak. METHODS: The epidemiologic investigation included site visits in 2 dental clinics and interviews with all involved healthcare workers. Chart reviews were conducted for case and control subjects. Samples were taken from medications and antiseptics, environmental surfaces, dental water systems, and from the involved healthcare professionals. Isolate similarity was assessed using repetitive element sequence-based polymerase chain reaction (REP-PCR). RESULTS: The 2 procedures were conducted in different dental clinics by different surgeons and dental technicians. A single anesthesiologist administered the systemic anesthetic in both cases. Cultures from medications, fluids and healthcare workers' hands were negative, but E. kobei was detected from the anesthesiologist's portable medication cart. The 2 human isolates and the environmental isolate shared the same REP-PCR fingerprinting profile. None of the 21 patients treated by the anesthesiologist in a general hospital during the same period, using the hospital's medications, developed infection following surgery. CONCLUSIONS: An outbreak of post-dental-procedure sepsis was linked to a contaminated medication cart, emphasizing the importance of medication storage standards and strict aseptic technique when preparing intravenous drugs during anesthesia. Immediate reporting of sepsis following these outpatient procedures enabled early identification and termination of the outbreak.

The Israeli national policy for discontinuation of isolation of carbapenem-resistant Enterobacterales carriers by carbapenemase type: a retrospective cohort study.

OBJECTIVES: The Israeli national policy for containing carbapenemase-producing Enterobacterales (CPE) includes a protocol allowing for discontinuation of carrier status following spontaneous decolonization. We examined the strategy's effectiveness based on carbapenemase type. METHODS: We performed a retrospective cohort study comparing individuals colonized with KPC- or NDM-producing Enterobacterales who underwent the process of isolation discontinuation. The primary outcome was reversion of carrier status, i.e. re-identification of the same CPE species following isolation discontinuation. We used survival analysis to estimate overall hazard ratio and performed competing-risks analysis using a Fine-Gray subdistribution hazard model and cause-specific hazard ratios. RESULTS: Between 1 January 2006 and 1 January 2019 we identified 1694 individuals who met inclusion criteria, including 1337 (78.9%) carriers of KPC-producing Enterobacterales, 305 (18.0%) carriers of NDM-producing Enterobacterales and 52 (3.1%) carriers of dual KPC-/NDM-producing Enterobacterales. A total of 134 individuals (7.9%) had reversion of carrier status: 9.1% (121/1337) and 4.3% (13/305) of individuals with KPC- and NDM-producing Enterobacterales, respectively. The subdistribution hazard ratio of status reversion was not increased among carriers of NDM producers compared with KPC producers (0.567, 95% CI 0.320-1.000], p 0.052). Cause-specific hazard ratios yielded similar results (0.522, 95% CI 0.291-0.937, p 0.029. CONCLUSIONS: Carriage of NDM-producing Enterobacterales was not associated with higher rates of reversion to carrier status following spontaneous decolonization than was carriage of KPC-producing Enterobacterales.

A multi-institutional outbreak of New Delhi metallo-ß-lactamase-producing Escherichia coli with subsequent acquisition of the Klebsiella pneumoniae carbapenemase gene.

We characterized 57 isolates from a 2-phase clonal outbreak of New Delhi metallo-ß-lactamase-producing Eschericha coli, involving 9 Israeli hospitals; all but 1 isolate belonged to sequence-type (ST) 410. Most isolates in the second phase harbored blaKPC-2 in addition to blaNDM-5. Genetic sequencing revealed most dual-carbapenemase-producing isolates to be monophyletically derived from a common ancestor.

National Policy for Carbapenem-Resistant Enterobacteriaceae (CRE) Clearance and Discontinuation of Contact Precautions for CRE Carriers in Post-Acute Care Hospitals in Israel: Impact on Isolation-Days and New Acquisitions.

BACKGROUND: In 2009, the Israeli Ministry of Health implemented in post-acute care hospitals (PACHs) a process of discontinuing carbapenem-resistant Enterobacteriaceae (CRE) carrier status. We evaluated the policy's impact on isolation-days, CRE prevalence among known carriers who had completed clearance testing, and CRE acquisition among noncarriers. METHODS: This retrospective study summarized findings from all 15 PACHs in 2009-2017. CRE carriers were considered cleared and removed from contact isolation after 2 rectal cultures negative for CRE and polymerase chain reaction negative for carbapenemases. Data sources included routine surveillance and 4 point prevalence surveys conducted from 2011 to 2017. RESULTS: During the study period, 887 of 6101 CRE carriers (14.5%) completed clearance testing. From 2013 to 2016, the percentage of patient-days in CRE isolation decreased from 9.4% to 3.9% (P = .008). In all surveys combined, there were 819 known CRE carriers; 411 (50%) had completed clearance testing. Of these, 11.4% (47/411) were CRE positive in the survey. At the ward level, the median percentage of patients with no CRE history who were positive on survey decreased from 11.3% in 2011 to 0% in 2017 (P < .001). We found no ward-level correlation between the proportion of carriers who completed clearance and new acquisitions (ρ = 0.02, P = .86). CONCLUSIONS: A process for discontinuing CRE carrier status in PACHs led to a significant reduction in the percentage of patient-days in contact isolation without increasing CRE acquisitions among noncarriers.

Investigation of Outbreaks of Extended-Spectrum Beta-Lactamase-Producing Klebsiella Pneumoniae in Three Neonatal Intensive Care Units Using Whole Genome Sequencing.

Infections caused by extended-spectrum beta-lactamase-producing Klebsiella pneumoniae (ESBL-KP) are on a constant rise and are a noted cause of outbreaks in neonatal intensive care units (NICUs). We used whole genome sequencing (WGS) to investigate the epidemiology of consecutive and overlapping outbreaks caused by ESBL-KP in NICUs in three hospitals in close proximity. Clonality of 43 ESBL-KP isolates from 40 patients was determined by BOX-PCR. Short-read sequencing was performed on representative isolates from each clone. The dominant clones from each NICU were sequenced using long-read sequencing. Bioinformatics methods were used to define multilocus sequence type (MLST), analyze plasmid content, resistomes, and virulence factors. In each NICU, we found a unique dominant clone (ST985, ST37, and ST35), each belonging to a distinct sequence type (ST), as well as satellite clones. A satellite strain in NICU-2 (ST35) was the dominant strain in NICU-3, where it was isolated four weeks later, suggesting transmission. NICU-1- and NICU-2-dominant strains had blaCTX-M-15 carried on a similar transposable element (Tn3-ISEcp1) but at different locations: on a plasmid and on the chromosome, respectively. We concluded that the overlapping ESBL-KP outbreaks were a combination of clonal transmission within NICUs, possible transposable element transmission between NICUs, and repeated importation of ESBL-KP from the community.

Fourier Transform Infrared Spectroscopy Is a New Option for Outbreak Investigation: a Retrospective Analysis of an Extended-Spectrum-Beta-Lactamase-Producing Klebsiella pneumoniae Outbreak in a Neonatal Intensive Care Unit.

The IR Biotyper is a new automated typing system based on Fourier-transform infrared (FT-IR) spectroscopy that gives results within 4 h. We aimed (i) to use the IR Biotyper to retrospectively analyze an outbreak of extended-spectrum beta-lactamase-producing Klebsiella pneumoniae (ESBL-KP) in a neonatal intensive care unit and to compare results to BOX-PCR and whole-genome sequencing (WGS) results as the gold standard and (ii) to assess how the cutoff values used to define clusters affect the discriminatory power of the IR Biotyper. The sample consisted of 18 isolates from 14 patients. Specimens were analyzed in the IR Biotyper using the default analysis settings, and spectra were analyzed using OPUS 7.5 software. The software contains a feature that automatically proposes a cutoff value to define clusters; the cutoff value defines up to which distance the spectra are considered to be in the same cluster. Based on FT-IR, the outbreak represented 1 dominant clone, 1 secondary clone, and several unrelated clones. FT-IR results, using the cutoff value generated by the accompanying software after 4 replicates, were concordant with WGS for all but 1 isolate. BOX-PCR was underdiscriminatory compared to the other two methods. Using the cutoff value generated after 12 replicates, the results of FT-IR and WGS were completely concordant. The IR Biotyper can achieve the same typeability and discriminatory power as genome-based methods. However, to attain this high performance requires either previous, strain-dependent knowledge about the optimal technical parameters to be used or validation by a second method.

The association between implementation of second-tier prevention practices and CLABSI incidence: A national survey.

BACKGROUND: Prevention of central-line-associated bloodstream infection (CLABSI) represents a complex challenge for the teams involved in device insertion and maintenance. First-tier practices for CLABSI prevention are well established. OBJECTIVE: We describe second-tier prevention practices in Israeli medical-surgical ICUs and assess their association with CLABSI rates. METHODS: In June 2017, an online survey assessing infection prevention practices in general ICUs was sent to all Israeli acute-care hospitals. The survey comprised 14 prevention measures supplementary to the established measures that are standard of care for CLABSI prevention. These measures fall into 2 domains: technology and implementation. The association between the number of prevention measures and CLABSI rate during the first 6 months of 2017 was assessed using Spearman's correlation. We used negative binomial regression to calculate the incidence rate ratio (IRR) associated with the overall number of prevention measures and with each measure individually. RESULTS: The CLABSI rates in 24 general ICUs varied between 0.0 and 17.0 per 1,000 central-line days. Greater use of preventive measures was associated with lower CLABSI rates (ρ, -0.70; P < .001). For each additional measure, the incidence of CLABSI decreased by 19% (IRR, 0.81; 95% CI, 0.73-0.89). Specific measures associated with lower rates were involvement of ward champions (IRR, 0.47; 95% CI, 0.31-0.71), auditing of insertions by infection control staff (IRR, 0.35; 95% CI, 0.19-0.64), and simulation-based training (IRR, 0.38; 95% CI, 0.22-0.64). CONCLUSION: Implementation of second-tier preventive practices was protective against CLABSI. Use of more practices was correlated with lower rates.

Success of a National Intervention in Controlling Carbapenem-resistant Enterobacteriaceae in Israel's Long-term Care Facilities.

BACKGROUND: Long-term care facilities (LTCFs) are a major reservoir of carbapenem-resistant Enterobacteriaceae (CRE) in healthcare facilities, contributing to rapid regional dissemination of CRE. METHODS: In 2008, The Israeli National Center for Infection Control (NCIC) initiated a coordinated, comprehensive intervention in Israel's LTCFs, encompassing approximately 25000 beds in over 300 institutions. The intervention included implementation of population-tailored contact precautions and early detection of carriers. The NCIC established a real-time repository of all CRE carriers and events of acquisition, supervised information exchange between healthcare facilities and directed intervention at the institutional level during local outbreaks. CRE incidence was determined based on detection of CRE, either during LTFC stay or on admission to another facility. Prevalence was determined by a series of 5 cross-sectional surveys commenced between 2008 and 2015. RESULTS: From January 2009 through December 2015, 5265 patients acquired CRE in LTCFs. During the study period, incidence of acquisition declined in all facility types, to approximately 50% of the baseline (P < .001). The number of skilled nursing facilities and nursing homes experiencing ≥ 5 CRE acquisitions annually decreased from 35 to 11 during this period. The point prevalence of newly detected CRE carriage in post-acute care hospitals decreased from 12.3% in the survey commenced in 2008 to 0.8% in that begun in 2015 (P < .001). CONCLUSIONS: A national, coordinated intervention resulted in a sustained decrease in CRE incidence and prevalence in LTCFs. These results support the assumption that centrally coordinated intervention is an essential public health tool in reducing CRE in healthcare facilities.

Israeli National Policy for Carbapenem-Resistant Enterobacteriaceae Screening, Carrier Isolation and Discontinuation of Isolation.

Since 2006, Israel has been confronting an outbreak of carbapenem-resistant Enterobacteriaceae (CRE), and in 2007 Israel implemented a national strategy to contain spread. The intervention was initially directed toward acute-care hospitals and later expanded to include an established reservoir of carriage in long-term-care hospitals. It included regular reporting of CRE cases to a central registry and daily oversight of management of the outbreak at the institutional level. Microbiological methodologies were standardized in clinical laboratories nationwide. Uniform requirements for carrier screening and isolation were established, and a protocol for discontinuation of carrier status was formulated. In response to the evolving epidemiology of CRE in Israel and the continued need for uniform guidelines for carrier detection and isolation, the Ministry of Health in 2016 issued a regulatory circular updating the requirements for CRE screening, laboratory diagnosis, molecular characterization, and carrier isolation, as well as reporting and discontinuation of isolation in healthcare institutions nationwide. The principal elements of the circular are contained herein. Infect Control Hosp Epidemiol 2018;39:85-89.

Epidemiological and microbiological characteristics of an outbreak caused by OXA-48-producing Enterobacteriaceae in a neonatal intensive care unit in Jerusalem, Israel.

This study describes the course of an OXA-48-producing Enterobacteriaceae (OPE) outbreak that started in March 2012 in a neonatal intensive care unit (NICU) in Jerusalem, Israel. During the peak of the outbreak (January to August 2012), there were 49 patients who had proven or suspected acquisition of OPE in the NICU, including 16 with invasive infections, out of a total of 156 patients who were hospitalized during that period. Three children hospitalized in the pediatric ICU were identified as carriers of OPE. Three patients with a previous stay in the affected NICU were identified as OPE carriers upon admission to another hospital. The Ministry of Health was notified and then intervened in July 2012. Intervention included cohorting colonized patients, conducting frequent rectal-culture surveillance, and improving the implementation of infection control practices. As a result, the incidence of OPE acquisition declined to 5 cases in the first 4 months, followed by no new cases in the next 3 months. Thirty-one patient-unique isolates were available for analysis: 29 Klebsiella pneumoniae isolates, all belonging to a single clone (sequence type 39 [ST39]), and 2 isolates from Enterobacter cloacae. All isolates possessed the blaOXA-48 and blaCTX-M-14 genes, which are located on the same plasmid. This plasmid, similar to the global blaOXA-48-harboring vector, has now acquired blaCTX-M-14, leading to resistance to all ß-lactam agents.

Introduction of OXA-48-producing Enterobacteriaceae to Israeli hospitals by medical tourism.

OBJECTIVES: The carbapenemase OXA-48 has been reported from different Mediterranean countries. It is mostly encoded on a single plasmid in various Enterobacteriaceae species. We characterized the epidemiological and molecular features of OXA-48-producing Enterobacteriaceae (OPE) in Israel. METHODS: Epidemiological investigation was conducted by the National Center for Infection Control. Genotyping was performed using multilocus sequence typing. The bla(OXA-48)-carrying plasmids were investigated using S1 endonuclease and restriction fragment length polymorphism (RFLP). Conjugation efficiency of the bla(OXA-48)-carrying plasmids was studied in a filter mating experiment. RESULTS: Since 2007, four OPE-infected patients were identified, all non-Israeli (two Palestinian, one Jordanian and one Georgian). Three had prior hospitalization; two in Jordan and one in Georgia. The bla(OXA-48) gene was detected in three Escherichia coli strains belonging to different clonal complexes, one Klebsiella oxytoca and one Klebsiella pneumoniae sequence type 101, as previously reported from Tunisia and Spain. In all isolates, the bla(OXA-48) gene was located inside Tn1999.2 and was carried on a 60 kb plasmid with an identical RFLP pattern. The plasmid was able to conjugate from Klebsiella spp. to E. coli, and had a conjugation efficiency up to ~10000 times higher than that of pKpQIL. CONCLUSIONS: OPE, introduced mainly by medical tourism, are an emerging threat to patients from affected Mediterranean countries. The bla(OXA-48)-carrying plasmid demonstrated remarkable conjugation efficiency, which is probably important in the success of its dissemination.

Containment of a country-wide outbreak of carbapenem-resistant Klebsiella pneumoniae in Israeli hospitals via a nationally implemented intervention.

BACKGROUND: During 2006, Israeli hospitals faced a clonal outbreak of carbapenem-resistant Klebsiella pneumoniae that was not controlled by local measures. A nationwide intervention was launched to contain the outbreak and to introduce a strategy to control future dissemination of antibiotic-resistant bacteria in hospitals. METHODS: In March 2007, the Ministry of Health issued guidelines mandating physical separation of hospitalized carriers of carbapenem-resistant Enterobacteriaceae (CRE) and dedicated staffing and appointed a professional task force charged with containment. The task force paid site visits at acute-care hospitals, evaluated infection-control policies and laboratory methods, supervised adherence to the guidelines via daily census reports on carriers and their conditions of isolation, provided daily feedback on performance to hospital directors, and intervened additionally when necessary. The initial intervention period was 1 April 2007-31 May 2008. The primary outcome measure was incidence of clinically diagnosed nosocomial CRE cases. RESULTS: By 31 March 2007, 1275 patients were affected in 27 hospitals (175 cases per 1 million population). Prior to the intervention, the monthly incidence of nosocomial CRE was 55.5 cases per 100,000 patient-days. With the intervention, the continuous increase in the incidence of CRE acquisition was halted, and by May 2008, the number of new monthly cases was reduced to 11.7 cases per 100,000 patient-days (P<.001). There was a direct correlation between compliance with isolation guidelines and success in containment of transmission (P=.02). Compliance neutralized the effect of carrier prevalence on new incidence (P=.03). CONCLUSIONS: A centrally coordinated intervention succeeded in containing a nationwide CRE outbreak after local measures failed. The intervention demonstrates the importance of strategic planning and national oversight in combating antimicrobial resistance.

The percentage of nosocomial-related out of total hospitalizations for rotavirus gastroenteritis and its association with hand hygiene compliance.

Because the absolute numbers of both community-acquired and nosocomial rotavirus gastroenteritis (RVGE) vary, we studied the percentage of hospitalizations for RVGE that were transmitted nosocomially as an indicator of in-hospital acquisition of the infection. In a 4-year prospective study, the percentage of nosocomial RVGE declined steadily, from 20.3% in 2003 to 12.7% in 2006 (P = .001). Concomitantly, the rate of compliance with hand hygiene increased from 33.7% to 49% (P = .012), with a significant (P < .0001) inverse association noted between the two trends.

Hospitalizations for nosocomial rotavirus gastroenteritis in a tertiary pediatric center: a 4-year prospective study.

BACKGROUND: Although rotavirus is the most common cause of gastroenteritis worldwide, data regarding nosocomial rotavirus gastroenteritis (NRVGE) are limited. Our objectives were to study the rates, seasonality, epidemiology, and clinical features of NRVGE. METHODS: This was a 4-year prospective study. RESULTS: NRVGE occurred in 1% of all admissions (356/35,833), 0.8% of all hospitalization days (1164/145,595) and 0.24 cases per 100 hospitalization days. Rates of NRVGE were age-dependent, occurring in 1.8%, 1.5%, 0.3%, and 0.1% of the admissions of children age < or = 1, > 1 to 2, > 2 to 5, and > 5 years, respectively (P < .001). Of the children age > 5 years, 90% received immunosuppressive treatment or had significant underlying diseases. The number of NRVGE cases was highest in winter months, but it occurred throughout the year, and its percentage of all hospitalizations for rotavirus gastroenteritis was highest in the summer months. NRVGE occurred after a median hospitalization of 6 days, required a median hospital stay of 3 days, and warranted treatment with intravenous fluids in 67% of cases. CONCLUSION: NRVGE is a significant health burden, especially in children age < or = 2 years, although it also can affect children age > 5 years with significant underlying disturbances. Vaccine prevention of rotavirus gastroenteritis also could reduce NRVGE and should be considered in cost-effectiveness analyses.

Catheter-associated bloodstream infections in pediatric hematology-oncology patients: factors associated with catheter removal and recurrence.

The aims of this study were to analyze the factors associated with antibiotic failure leading to tunneled central venous catheter (CVC) removal during catheter-associated bloodstream infections (CABSIs) and with recurrence and reinfection in children with cancer. All cases of CABSI in patients attending the Department of Pediatric Hematology-Oncology between November 2000 and November 2003 were reviewed. A total of 207 episodes of CABSI, including multiple episodes involving the same catheter, were identified in 146 of 410 tunneled CVCs (167 Hickman, 243 implantable ports). The most common organism isolated was coagulase-negative Staphylococcus (CONS). The CVC was removed in 96 (46%) episodes. Hypotension, persistent bacteremia, previous stem cell transplantation, multiple CABSIs in the same CVC, exit-site infection, inappropriate empiric antibiotic therapy, and Candida infection were all significantly associated with increased risk of catheter removal (P < 0.05, odds ratios 7.81, 1.14, 2.22, 1.93, 3.04, 2.04 and 24.53, respectively). There were 12 episodes of recurrent infection, all except 1 caused by CONS (odds ratio 20.5, P = 0.006). Inappropriate empiric therapy, especially in implantable ports, was the only mutable risk factor for antibiotic failure. Because CONS was the predominant isolate in these devices, adding glycopeptides to the empiric therapy for suspected implantable-port CABSI might decrease the removal rate. This issue should be explored in future controlled trials.

Chlorhexidine-impregnated dressing for prevention of colonization of central venous catheters in infants and children: a randomized controlled study.

BACKGROUND: Infections of short term, nontunneled, intravascular catheters are often caused by migration of organisms from the insertion site. The aim of this study was to evaluate the effectiveness and safety of a chlorhexidine gluconate-impregnated dressing for the reduction of central venous catheter (CVC) colonization and CVC-associated bloodstream infections in infants and children after cardiac surgery. METHODS: This prospective, randomized, controlled study was conducted in the pediatric cardiac intensive care unit of a tertiary care pediatric medical center. Patients 0-18 years of age who were admitted to the pediatric cardiac intensive care unit during a 14-month period and required a CVC for >48 hours were randomized to receive a transparent polyurethane insertion site dressing (control group) or a chlorhexidine gluconate-impregnated sponge (Biopatch) dressing covered by a transparent polyurethane dressing (study group). The main outcome measures were rates of bacterial colonization, rates of CVC-associated bloodstream infections and adverse events. RESULTS: Seventy-one patients were randomized to the control group and 74 to the study group. There were no significant between group differences in age, sex, Pediatric Risk of Mortality score or cardiac severity score. CVC colonization occurred in 21 control patients (29%) and 11 (14.8%) study patients (P = 0.0446; relative risk, 0.6166; 95% confidence interval, 0.3716-1.023). Bloodstream infection occurred in 3 patients (4.2%) in the control group and 4 patients (5.4%) in the study group. Local redness was noted in 1 control patient and 4 study group patients. CONCLUSIONS: The chlorhexidine gluconate-impregnated sponge is safe and significantly reduces the rates of CVC colonization in infants and children after cardiac surgery.