Overall Rate Of Infection Research Articles

Predicting and reducing cranioplasty infections by clinical, radiographic and operative parameters – A historical cohort study

Cranioplasty is a relatively straightforward and common procedure, yet it carries a substantial rate of infection that causes major morbidity and mortality. The authors’ objective was to assess the effect of various variables on the risk of developing post-cranioplasty infections, and to enable the prediction and reduction of its incidence, contributing to an improved patient-selection. The medical records, microbiologic cultures, imaging studies and operative reports of patients who have undergone cranioplasty between the years 2008–2014 at Sheba Medical Center, a tertiary care teaching hospital in Tel-Hashomer, Israel, were reviewed and evaluated for potential predictive factors of infection. Cox regression was applied for uni- as well as multi-variate analyses, and a Kaplan–Meier curve and Log-Rank test were used to describe the association between neurological deficit prior to operation and occurrence of infection. Eighty-eight patients who had undergone cranioplasties using autologous as well as various artificial materials were included in the study. The overall rate of infection was 13.6%; median time to infection was 30.5 days (interquartile range: 17.35–43.5). Pre-operative degree of neurological disability was the strongest predictor for infection in both uni- and multi-variate analyses (Hazard ratio [HR]=18.9, 95% confidence interval [CI]: 1.9–187 p=0.014). Patients admitted due to trauma (HR=7.04 CI: 0.9–54.6, p=0.062) and autologous graft material (HR=2.88, 95% CI: 0.92–9.09, p=0.07) were associated with a trend toward a higher risk for infection. In conclusion, careful patient selection is a key concept in avoiding harmful post-cranioplasty infections. Modified Rankin Score yields a well-established tool that predicts the risk of infection.

Do Prior Intra-Articular Corticosteroid Injections or Time of Administration Increase the Risks of Subsequent Periprosthetic Joint Infections after Total Knee Arthroplasty?

Intra-articular injections of corticosteroids have been used as a treatment option for degenerative arthritis of the knee for short- to mid-term symptomatic pain relief for many decades. Recently, there have been studies that have reported increased risks of periprosthetic joint infections in patients who have received these injections. In this study, we evaluated the risk of superficial, deep, and overall rate of infections in 302 patients who had received intra-articular corticosteroid infiltration within 12 months before undergoing total knee arthroplasty (TKA) and compared them with a 1:1 matched cohort who had undergone TKA, but who did not have any prior corticosteroid knee injections. At a mean follow-up of approximately 3.5 years after TKA, there were no significant differences in the rate of superficial incisional infections (7 vs. 6 out of 302 patients), deep periprosthetic infections (3 vs. 6 out of 302 patients), and overall infections (10 vs. 12 out of 302 patients) in the two groups. In addition, no significant differences were found in the rate of deep infections when intra-articular corticosteroids were administered 10 weeks to 2 months, 2-4 months, 4-6 months, 6-12 months, and beyond 12 months before surgery. We concluded that intra-articular corticosteroid injections are safe and do not increase the rate of postoperative infections.

Infection and readmission rate of cardiac implantable electronic device insertions: An observational single center study

Infection is one of the most serious complications following surgical placement of cardiac implantable electronic devices (CIEDs). Infection prevention efforts are necessary in reducing CIED infectious outcomes. These devices, however, are commonly inserted in higher risk patients, which may explain the ongoing risk of surgical site infection (SSI) in this population. The rates of CIED infection and utilization vary widely in the literature. The definitions of infection may also vary between clinical definitions and the National Healthcare Safety Network (NHSN) criteria. The primary objective of this study was to review patient data to identify risk factors for infection and readmission after CIED placement at an academic medical center. The secondary objectives were to compare the rates of SSI identified by NHSN criteria compared to that obtained by applying clinical infection definitions. The overall rate of infection (SSI) was 1.9%, which was identical in both the clinical definition and NHSN reported data. The 30 day readmission rate and the 90 day readmission rate were 12.7% and 25.6% respectively with the most readmissions related to the patients' underlying medical conditions. A lower ejection fraction (EF) was identified as an independent risk factor for readmission, inpatient procedures, smoking and device infection were also significantly associated with readmission after CIED insertion.

Clinical outcomes of immunoglobulin use in solid organ transplant recipients: protocol for a systematic review and meta-analysis.

BackgroundTransplantation improves survival and the quality of life of patients with end-stage organ failure. Infection, due to surgical issues, host factors such as diabetes, immunosuppression, and hypogammaglobulinemia, is a major post-transplant complication. Clinical outcomes of prophylaxis or treatment of hypogammaglobulinemia in solid organ transplant recipients are not well established and are in need of further study.Methods/designWe will conduct a systematic review of studies investigating clinically relevant outcomes of immunoglobulin use either as prophylaxis or treatment of hypogammaglobulinemia after solid organ transplantation. Both randomized and non-randomized studies (excluding case reports and case series of less than 20 subjects) will be included. Outcomes of interest will include the overall rate of infection, hospital admission, hospital length of stay, intensive care unit admission, 1-year all-cause mortality, incidence of acute organ rejection, allograft survival within 1 year, and adverse events. We will search MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, Transplant library, and the International Clinical Trials Registry Platform for randomized and non-randomized studies on adult solid organ transplant patients who received prophylactic immunoglobulin or immunoglobulin treatment. Two reviewers will conduct all screening and data collection independently. We will assess study level of risk of bias using the Cochrane Risk of Bias Assessment Tool for randomized controlled trials and for non-randomized studies. If meta-analysis of outcome data is deemed appropriate, we will use random effects models to combine data for continuous and dichotomous measures.DiscussionThe results of this systematic review may inform guideline development for measuring immunoglobulin level and use of immunoglobulin in solid organ transplant patients and highlight areas for further research.Systematic review registrationPROSPERO CRD42015017620Electronic supplementary materialThe online version of this article (doi:10.1186/s13643-015-0156-6) contains supplementary material, which is available to authorized users.

The use of vascular access audit and infections in home hemodialysis.

Vascular access-related infection is an important adverse event in home hemodialysis (HHD). We hypothesize that errors in self-cannulation or manipulation of dialysis vascular access are associated with increased incidence of access-related infection. We conducted a retrospective cohort study of all prevalent HHD patients at the University Health Network. All vascular access-related infections were recorded from 2006 to 2013. Errors in dialysis access were ascertained by nurse-administered vascular access checklist. Ninety-two patients had completed at least one vascular access audit. Median HHD vintage was 2.3 (0.9-5.0) years in patients with appropriate vascular access technique and 5.8 (1.5-9.4) years in patients with erroneous vascular access technique. The overall rate of infection between patients with and without appropriate vascular access technique was similar (0.27 and 0.28 infections per year, P = 0.166). Among patients who were identified with errors in dialysis access manipulation, patients with five or more errors were associated with higher rate of access-related infection (mean of 0.47 vs. 0.16 infection per patient-year, P < 0.001). The use of vascular access audit is a feasible strategy, which can identify errors in vascular access technique. Patients with a longer median HHD vintage are associated with higher risk of inappropriate vascular access technique. Patients with multiple errors in vascular access technique are associated with a higher risk of dialysis access-related infection. Prospective evaluation of the impact of vascular access audit on adverse vascular access events is warranted.

Prevention of Subsequent Catheter-Related Bloodstream Infection Using Catheter Locks in High-Risk Patients Receiving Home Parenteral Nutrition.

Catheter-related bloodstream infection (CRBSI) is a serious complication in patients receiving home parenteral nutrition (HPN). Antibiotic lock therapy (ALT) and ethanol lock therapy (ELT) can be used to prevent CRBSI episodes in high-risk patients. Following institutional review board approval, all patients enrolled in the Mayo Clinic HPN program from January 1, 2006, to December 31, 2013, with catheter locking were eligible to be included. Patients without research authorization and <18 years old at the initiation of HPN were excluded. Total number of infections before and after ALT or ELT were estimated in all patients. A total of 63 patients were enrolled during the study period. Of 59 eligible patients, 29 (49%) were female, and 30 (51%) were male. The median duration of HPN was 3.66 (interquartile range, 0.75-8.19) years. The mean age ± SD at initiation of HPN was 49.89 ± 14.07 years. A total of 51 patients were instilled with ALT, and 8 patients were instilled with ELT during their course of HPN. A total of 313 CRBSI episodes occurred in these patients, 264 before locking and 49 after locking ( P < .001). Rate of infection per 1000 catheter days was 10.97 ± 25.92 before locking and 1.09 ± 2.53 after locking ( P < .001). The major findings of the present study reveal that ALT or ELT can reduce the overall rate of infections per 1000 catheter days. ALT or ELT can be used in appropriate clinical setting for patients receiving HPN.

P11.12 Pharyngealneisseria gonorrhoeaeandchlamydia trachomatisin men and women with a history of receptive oral and anal intercourse

Introduction Both women and men who have sex with men (MSM) report frequent receptive oral sex, but there are no FDA approved tests for detection of Neisseria gonorrhoeae (GC) and Chlamydia trachomatis (CT) from pharyngeal swabs. The objective of this study was to evaluate the number of pharyngeal GC and CT infections, and to assess the sensitivity of GC culture. Methods Women (n = 172) and MSM (n = 222) reporting a lifetime history of both receptive oral and anal sex completed a structured questionnaire and clinicians collected swab samples from the pharynx and anorectum. Vaginal swabs were obtained from women and urine samples from men. Testing for CT and GC was performed using Cepheid Xpert CT/NG (Xpert) and Gen-Probe Aptima (AC2). True positives were defined if both AC2 and Xpert were positive, if GC culture was positive, or if either AC2 or Xpert were positive and confirmatory tests APTIMA CT or APTIMA GC were positive. Results Identification of GC and/or CT at any site (pharyngeal, rectal or genitourinary) occurred in 78/222 (35%) males and 25/172 (14.5%) of females. Only 8 (2%) of pharyngeal swab samples were positive for CT, while 4 women (2.3%) and 37 (16.7%) men tested positive for pharyngeal GC based on NAAT. GC culture of the pharynx was performed for 373 of participants in the study, and was positive in 13 (3.5%), for a sensitivity of 32% for culture vs NAAT. Overall, 17/55 (31%) of the total GC infections in men would have been missed without NAAT pharyngeal testing. Conclusion Men who report a lifetime history of receptive oral intercourse have high rates of pharyngeal GC, most of which will remain undetected unless NAAT is used. The frequency of pharyngeal infection due to CT is low even among people having high overall rates of infection. Disclosure of interest Reagents for CT/GC testing were provided for by Cepheid and Hologic.

Sporozoan Protozoa and Enteroparasites in the Gastroenteritic Patients Referring to the Healthcare Centers of Seven Provinces of Iran

Background: Sporozoan protozoa and enteroparasites cause gastroenteritis. Sporozoa are the major cause of self-limiting diarrhea in immunocompetent patients, however they cause serious diseased in patients with immunosuppression. Objectives: The current study aimed to identify the prevalence of sporozoa and enteroparasites among patients with gastroenteritis referred to the healthcare centers in seven provinces of Iran. Patients and Methods: In this cross-sectional study, 4200 stool samples were randomly collected from patients with gastroenteritis in the selected hospitals of Gilan, East Azerbaijan, Qazvin, Kurdistan, Mazandaran, Tehran and Khorasan-e-Razavi provinces. Primarily samples were examined directly for enteroparasites. The samples were then filtered and concentrated using Paraseb kit. The pellets were fixed, stained by different assays including acid fast staining, Auramin Phenol Fluorescence, Giemsa and light microscopy. Results: The results revealed the overall rate of infection, 3.86% (163 cases), as an indicator of parasitic enteropathogens in Iran. Among the provinces, Khorasan-e-Razavi and Mazandaran with 8.83% (53 cases) and 0.34% (2 cases) showed the highest and lowest rates of infection, respectively. The frequencies of sporozoa including Cryptosporidium, Microsporidium, Isospora and Cyclospora spp. were 0.1%, 0.1%, 0.07% and 0.02% respectively. Among the parasites, Giardia lambelia, Taenia saginata and Hookworms with 1.78% and 0.02% had the highest and lowest rates of infection, respectively. Regarding the age groups, the highest and the lowest rates of infection were in 0 - 10 (48%) and 41 years old and above (6.7%) groups, respectively. Conclusions: Despite relatively low prevalence of sporozoa, giardiosis is the most prevalent agent for gastroenteritis amongst 3.86% of parasitic infections in Iran. The current study confirmed the abundance of infection in warm and wet seasons, and more frequency of infections among children than adults. Meanwhile, geographical and agricultural conditions, seasonal rainfall, abundance of water, and animal contact are key factors affecting sporozoan infections.

Borrelia burgdorferi sensu lato and co-infections with Anaplasma phagocytophilum and Rickettsia spp. in Ixodes ricinus in Hamburg, Germany.

To obtain initial data on Borrelia burgdorferi sensu lato (Spirochaetales: Spirochaetaceae) in Ixodes ricinus (Ixodida: Ixodidae) ticks in Hamburg, Germany, 1400 questing ticks were collected by flagging at 10 different public recreation areas in 2011 and analysed using probe-based quantitative real-time polymerase chain reaction. The overall rate of infection with B. burgdorferi s.l. was 34.1%; 30.0% of adults were infected (36.7% of females and 26.0% of males), as were 34.5% of nymphs. Significant differences in tick infection rates were observed between the spring and summer/autumn months, as well as among sampling locations. Borrelia genospecies identification by reverse line blotting was successful in 43.6% of positive tick samples. The most frequent genospecies was Borrelia garinii/Borrelia bavariensis, followed by Borrelia afzelii, Borrelia valaisiana, B. burgdorferi sensu stricto, Borrelia spielmanii, Borrelia bissettii and Borrelia lusitaniae. Based on previously published data, co-infection of Borrelia and Rickettsiales spp. was determined in 25.8% of ticks. Overall, 22.9% of ticks were co-infected with Rickettsia spp. (Rickettsiales: Rickettsiaceae), 1.7% with Anaplasma phagocytophilum (Rickettsiales: Anaplasmataceae), and 1.2% with both pathogens. Study results show a high prevalence of Borrelia-positive ticks in recreation areas in the northern German city of Hamburg and the potential health risk to humans in these areas should not be underestimated.

Bacterial infections associated with allogenic bone transplantation.

Bone allografts are frequently used in orthopedic reconstructive procedures carrying a high risk for recipients. To assess the nature and frequency of allograft contamination and associated surgical infection the case records from our institutional bone bank were reviewed. We retrospectively analyzed the microbiology of discarded bone allografts and the surgical site of the recipients. A case series of patients who acquired surgical site infection after allogenic bone transplantation was presented. Swab culturing was conducted on 309 femoral heads from living donors who underwent partial and total hip arthroplasty between January 2007 and December 2013. To prevent potential bone allograft contamination we used saline solution of 2.0 mg/ml of amikacin during thawing. The overall infection rate was analyzed in 197 recipients. Of the 309 donated femoral heads, 37 were discarded due to bacterial contamination, giving the overall contamination rate of 11.97%. The postoperative survey of 213 bone allotransplantations among 197 recipients showed the infection rate of 2.03%. The coagulase-negative Staphylococcus was the most commonly identified contaminant of bone allografts and recipient surgical sites. The allograft contamination rate and the infection rate among recipients in our institution are in accordance with the international standards. The coagulase-negative Staphylococcus was the most commonly identified contaminant of bone allografts,and recipient surgical sites. There is no strong evidence that surgical site infections were associated with bone allograft utilization. We plan further improvements in allograft handling and decontamination with highly concentrated antibiotic solutions in order to reduce infection risk for recipients.

Solid organ transplantation: hypogammaglobulinaemia and infectious complications after solid organ transplantation.

Solid organ transplantation: hypogammaglobulinaemia and infectious complications after solid organ transplantation.

The Effects of the Hand Hygiene Initiative on Hand Hygiene Compliance and Nosocomial Infection Rate: an Experience in a Single Center Surgical ICU

Background: Between 5~10% of hospitalized patients in developed nations are affected with nosocomial infections (NCIs), therates are even higher among intensive care unit (ICU) patients. Robust evidence suggests that proper hand hygiene has anessential role in the prevention of NCIs. However, in despite of the overwhelming evidence, hand hygiene compliance amonghealth care providers (HCPs) was lower than expected. This study was performed to evaluate the impacts of the Hand HygieneInitiative (HHI) on compliance of hand hygiene and the rate ofN CI in a single center surgical ICU.Methods: All HCPs (physicians, nurses, radiographers and physical therapists) who had accessed the Jeju National UniversityHospital (JNUH) Surgical ICU were the subjects of this study. The HHI composed of five activities: lectures, monitoring of handhygiene compliance, complement facilities, encouraging handrubs use and abiding by the rules concerning isolated patients.Surveillances of NCI rates and hand hygiene compliances before and during the activities were monitored by the "InfectionControl Committee of JNUH".Results: Hand hygiene compliance improved from 74.0% before the activities to 89.4% during the activities (p&lt;0.0001).Overallinfection rate ofJ NUH-SICU decreased from 5.98 to 3.98 per 1,00 patient-days which was not statistically significant (p=0.38).Conclusions: Hand hygiene compliance was improved by HHI, but further efforts will be needed to maintain this impact. HHIdiminished the NCI rate in a single institute surgical ICU, but following studies will be needed to assess whether theimprovement was statistically significant.

Indolent infection in nonunion of the distal femur.

In the treatment of nonunions of the distal femur, infection should be excluded. However, it is difficult to determine whether the nonunion is infected or not with negative history and signs of infection. The purpose of this study was to investigate indolent infection as a cause of presumptive aseptic distal femur nonunion. All presumptive aseptic distal femur nonunions treated from 1998 to 2008 were retrospectively reviewed. Any patient with suspected of having an infection clinically was excluded. Multiple tissue cultures were performed at the nonunion site. The main outcomes were to analyze the rate of positive cultures in presumptive aseptic distal femur nonunion and to compare the rate of secondary surgery in positive and negative culture groups. Of the 22 patients, 3 (13.6%) had positive culture results. The organisms cultured were Staphylococcus aureus, Staphylococcus epidermidis, and Enterobacter cloacae. The overall rate of infection was 9.1% (2/22), and one patient underwent a secondary procedure. In the open fracture group, 2 of 10 patients (20%) had positive cultures; all developed infection. In the closed fracture group, 1 of 12 patients (8.3%) had positive culture results, but Infection did not occur in the patient with a 3-week intravenous antibiotic treatment. The postoperative infection rate was 67% (2/3) in patients with positive intraoperative cultures, while 0% (0/18) in the group with negative intraoperative cultures (p<0.001). The presence of indolent infection can be verified in patients with presumptive aseptic nonunion of distal femoral fractures by obtaining intraoperative biopsy tissue cultures. Positive intraoperative culture results were related with postoperative infection.

Identification of malnutrition in children with severe neuromotor disabilities: A still overlooked aspect in our country

s / Digestive and Liver Disease 46 (2014) e85–e127 e99 Methods: We retrospectively collected data (2000–2014) on children undergoing long-termPN (>6months) for different underlying conditions: Short Bowel Syndrome (SBS), Intestinal Motility Disorders (IMD) and severe Neurological Diseases (ND). The rate of CLABSI/1000 catheter-days was considered as main outcome. Occurrence of mechanical complications and replacement were also recorded. Results: Twenty children were included in the study: 11 with SBS (55%), 6 with IMD (30%) and 3 with ND (15%). During a total of 24,424patients-days, 28mechanical complicationswere registered and 34 central-lines were removed. CLABSI was the major cause of catheter replacement (18/34, 53%). An overall rate of infections of 7.01 CLABSI/1000 catheter-days was registered in the first year of PN and it progressively reduced in the following years reaching 3.06/1000 between 3–4 years and 0.86/1000 after 6 years of PN. CLABSI rate was higher in children with SBS and IMD (7.42 and 7.94/1000 catheter-days, respectively) than in those with ND (2.63/1000 catheter-days). Coagulase-negative Staphylococci were the most commonly isolated pathogens (65%), in 5 cases a polymicrobial infection was detected. Conclusions: Infections are a leading cause of morbidity in children receiving PN. The risk of infection varies according to underlying conditions and progressively decreases, probably in parallel with child growth and improvement of caregivers ability to home management. http://dx.doi.org/10.1016/j.dld.2014.07.089 IDENTIFICATION OF MALNUTRITION IN CHILDREN WITH SEVERE NEUROMOTOR DISABILITIES: A STILL OVERLOOKED ASPECT IN OUR COUNTRY Maria Sangermano1,∗, Roberta D’Aniello1, Grazia Massa1, Pasquale Pisano2, Giangennaro Coppola3, Marco Poeta1, Luca Pierri 1, Dario Di Salvio1, Giulia Paolella1, Pietro Vajro4 1 Universita degli Studi di Salerno, Pediatrics Section Dept Medicine and Surgery, Universita di Salerno, Baronissi Salerno, Italy 2 Universita degli Studi di Salerno, Pediatrics, AOU Ruggi D’Aragona, Salerno, Italy 3 Universita degli Studi di Salerno, Neuropediatrics Section Dept Medicine and Surgery, Univ Salerno, Baronissi Salerno, Italy 4 Universita degli Studi di Salerno, Pediatrics Section Dept Medicine and Surgery, Univ Salerno, Baronissi Salerno, ELFID, Naples, Italy Objective: Several neuromotor disorders are associated with nutritional difficulties, a quite often underestimated or overlooked problem. Our study aims to delineate the frequency ofmalnutrition in a series of non-hospitalized, neurologically impaired Southern Italy children. Methods:Thirty patients, 21males and9 females, agedbetween 2 and 15 years with cerebral palsy (n=15), epileptic encephalopathy (n=6), severe psychomotor developmental delay (n=5), genetic syndromes (n=4). Nutritional status was assessed by anthropometric parameters [weight, estimated height by specific body segments measurement, BMI, Plicometry], blood count, serum levels of iron, albumin, transferrin, calcium, phosphorus. Feeding and a 3 days food diary were recorded. Results: Approximately from one third to half of the study population was at serious risk of malnutrition according to the reported feeding difficulties [about 90% of patients required conTable 1 kcal/die Carbohydrates Lipids Proteins Patients 1092±215 134.2±19.0 (46%) 45.4±8.9 (37%) 45.9±17.7 (17%) References 1474±411* 55-60% (RDI) 33–30% (RDI) 12–15% (RDI) RDI =Reference Daily Intake. * Krick’s formula (Krick et al., 1996). stant substantial assistance during meals, usually >30min/meal (mean 45min)], progressive weight depletion [ 0.3 unless otherwise specified, are shown. Sleep deprivation/fragmentation, nocturnal breathing problems and daytime sleepiness increased with BMI, correlating with clinical markers of metabolic syndrome (Acanthosis Nigricans and blood pressure). Frequency and amounts of sugary drinks consumption closely paralleled the BMI excess and all the other anthropometric parameters. A positive correlation was found also with factors influencing gut microbiota [bottle formula feeding/antibiotic therapies], whereas probiotics/prebiotics treatments correlated negatively with waist circumference and diastolic blood pressure. In the whole population the average concentration of total urinary BPAwas 1.13±0.89ng/ml. Free and total BPA increased paralleling BMI and all other obesity markers with a remarkable positive correlation (r>0.8), whereas the conjugate BPA behaved the opposite way. Conclusions: Our results confirm the existence of a close relationship between these 4 emerging factors and pediatric obesity, highlighting their possible role as targets for preventive/therapeutic tools. http://dx.doi.org/10.1016/j.dld.2014.07.091

Prebiotics in healthy infants and children for prevention of acute infectious diseases: a systematic review and meta-analysis.

Prebiotics, defined as nondigestible dietary ingredients resistant to gastric acidity and fermented by the intestinal flora, are used to positively influence the composition of intestinal flora, thereby promoting health benefits. The objective of this systematic review was to assess the efficacy of prebiotics in the prevention of acute infectious diseases in children. A systematic literature search was conducted using the Ovid Medline, Scopus, Web of Science, and Cochrane Library's Central databases. Finally, five randomized controlled trials, all of them investigating infants and children 0-24 months of age, were included in the review. Pooled estimates from three studies revealed a statistically significant decrease in the number of infectious episodes requiring antibiotic therapy in the prebiotic group as compared with the placebo group (rate ratio 0.68; 95% confidence interval 0.61-0.77). Studies available indicate that prebiotics may also be effective in decreasing the rate of overall infections in infants and children 0-24 months of age. Further studies in the age group 3-18 years are required to determine whether prebiotics can be considered for the prevention of acute infectious diseases in the older pediatric population.

One-year Efficacy and Safety Results of Secukinumab in Patients With Rheumatoid Arthritis: Phase II, Dose-finding, Double-blind, Randomized, Placebo-controlled Study

To evaluate the longer-term safety and efficacy of secukinumab, a fully human monoclonal antiinterleukin-17A antibody, in patients with rheumatoid arthritis. In this 52-week, double-blind, placebo-controlled (up to Week 20) study (NCT00928512), patients responding inadequately to disease-modifying antirheumatic drugs (DMARD) or biologics were randomized to receive monthly subcutaneous injections of secukinumab (25, 75, 150, or 300 mg), or placebo. The efficacy and safety results up to Week 20 have been reported previously. Here, efficacy results from Week 20 to 52 and safety results from Week 20 to 60 are presented. Of 237 patients randomized, 174 (73.4%) completed the study. Patients with improved American College of Rheumatology (ACR) and 28-joint Disease Activity Score (DAS28) C-reactive protein (CRP) responses at Week 16 sustained their responses through Week 52. In patients taking 150 mg of secukinumab, responses were improved through Week 52 (ACR50: Week 16 = 45%, Week 52 = 55%; DAS28-CRP ≤ 2.6: Week 16 = 25%, Week 52 = 40%). The rate of adverse events (AE) from weeks 20 to 60 was 64.8%, with most AE being mild to moderate in severity. The overall rate of infections was 31.9%, most being mild. The most predominant infection was nasopharyngitis, and was not associated with dose or concurrent neutropenia. Serious AE were reported in 21 patients (8.9%). There were 3 reports of malignancies (ovarian, lung, basal cell), and no deaths between weeks 20 and 60. Patients with active RA who failed to respond to DMARD and other biologics showed an improvement after longterm treatment with 150 mg of secukinumab. The frequency of AE remained stable over time and secukinumab had a consistent safety profile over 60 weeks.

Open-Label Observation of Addition of Etanercept Versus a Conventional Disease-Modifying Antirheumatic Drug in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy in the Latin American Region

Previous global studies examined etanercept (ETN) + methotrexate (MTX) for treatment of rheumatoid arthritis (RA), but included few subjects from Latin America. The objective of this study was to compare the safety and efficacy of ETN + MTX versus a standard-of-care disease-modifying antirheumatic drug (DMARD) + MTX in Latin American subjects with moderate to severe active RA despite MTX therapy. This open-label, active-comparator study (NCT00848354) randomized subjects 2:1 to ETN 50 mg/wk + MTX or investigator-selected DMARD (sulfasalazine or hydroxychloroquine) + MTX (ETN + MTX, n = 281; DMARD + MTX, n = 142). The primary end point was the proportion achieving American College of Rheumatology (ACR) 50 at week 24. Secondary end points included ACR20/70, disease activity score (DAS) 28 measures, and mean change in modified total Sharp score. Patient-reported outcomes were the Health Assessment Questionnaire, 36-item Short-Form, Hospital Anxiety and Depression Scale, Work Productivity and Activity Impairment: RA (WPAI:RA), and Caregiver Burden and Resource Utilization. Statistical analyses were stratified by country; χ test and analysis of covariance were used. Adverse events were monitored. More subjects achieved ACR50 at week 24 with ETN + MTX versus DMARD + MTX (62% vs 23%, respectively), in addition to secondary end points (P < 0.0001 for all); mean change in modified total Sharp score was lower for the ETN + MTX group (0.4 vs 1.4, respectively; P = 0.0270). Improvements in patient-reported outcomes favored ETN + MTX for Health Assessment Questionnaire, 36-item Short-Form, Hospital Anxiety and Depression Scale for depression, WPAI:RA, and Caregiver Burden and Resource Utilization emergency department visits for RA (P < 0.01). Overall, adverse events were similar between the groups (69% vs 68%,); serious adverse events were also similar (4% vs 1%). The rate of overall infections was higher with ETN + MTX (38%) than DMARD + MTX (22%, P ≤ 0.001). Consistent with published global data among RA patients with inadequate response to MTX, adding ETN to MTX demonstrated better efficacy than adding one other conventional DMARD to MTX. No new safety issues were observed. ETN + MTX provided favorable benefit-risk profile among RA patients from LA region.

Comparison of Gentamicin Ointment to Mupirocin Ointment for Prevention of Peritoneal Dialysis Catheter-Related Infections

In July 2007, all peritoneal dialysis (PD) patients in our hospital were switched from mupirocin to gentamicin ointment for daily application to the PD catheter exit site (CES). Our objective was to compare the efficacy of gentamicin and mupirocin in the prevention of catheter-related PD infections. We conducted an observational sequential cohort study to compare infectious outcomes with the 2 ointments. Mupirocin patients were followed retrospectively from January 2004 to June 2006 and gentamicin patients prospectively from July 2007 to December 2008. All patients were followed for 18 months following catheter insertion. Fifty-nine patients were included in the mupirocin arm and 37 patients in the gentamicin arm. Time to first infection (either CES or peritonitis) was similar between arms, with a probability of being infection-free at 12 months of 67% versus 53%, respectively (p=0.34). There were no differences in rates of overall infection (0.54 vs 0.56 infections per patient-year, respectively (p=0.94)) or peritonitis (0.41 vs 0.37 per patient-year, respectively (p=0.84). There were 5 pseudomonal infections in the mupirocin arm and none with gentamicin. It was concluded that topical gentamicin has comparable effectiveness to mupirocin for prevention of PD catheter-related infections. Keywords: Gentamicin, mupirocin, peritoneal dialysis, peritonitis.

Serial Monitoring of Complement Levels Identifies Kidney Transplant Recipients at High Risk of Infection: A Prospective Study

Objectives: The complement system plays an important role in mediating both acquired and innate responses to defend against infection. The usefulness of serial monitoring of complement levels to assess the risk of infection in kidney transplant (KT) recipients is not well established. Methods: In this observational cohort study we prospectively included 235 patients (151 males; mean age: 53.9 ± 14.2 years) who underwent KT at our institution from November 2008 to August 2010. Complement levels (C3 and C4) were determined by nephelometry just before transplantation (T0) and at months 1 (T1) and 6 (T6) post-transplant. We defined C3 hypocomplementemia as a decrease in serum levels below the lower normal limit in our laboratory (83 mg/dL). The primary study outcome was the occurrence of at least one episode of post-transplant infection. We divided the post-transplant follow-up period in three intervals: early (first month), intermediate (1-6 months), and late (>6 months). Multivariate adjusted odds ratios (ORs) were calculated using those covariates that were found to be significant at P < 0.10 by univariate analysis. Results: The incidence of C3 hypocomplementemia progressively decreased along the study period: 25.1% at baseline (T0), 18.7% at T1, and 8.9% at T6 (P = 0.004). The median duration of follow-up was 509 days. A total of 150 recipients (63.8%) developed 356 episodes of post-transplant infection (overall incidence rate: 2.75 per 1,000 transplant-days). Patients with C3 hypocomplementemia at T0 did not experience higher rates of infection in the early period. Patients with C3 hypocomplementemia at T1 had increased incidences of any type of infection (P = 0.013), bacterial infection (P = 0.008), acute graft pyelonephritis (P = 0.030), cytomegalovirus infection (P = 0.031), and other viral infection (P = 0.007) during the intermediate period. The incidence rates of overall infection during this period in patients with and without C3 hypocomplementemia at T1 were 9.81 and 4.68 episodes per 1,000 transplant-days, respectively (P < 0.001). Finally, C3 hypocomplementemia at T6 was associated with a higher incidence rate of overall infection in the late period (1.90 vs. 0.82 episodes per 1,000 transplant-days; P = 0.032), and higher cumulative incidence of bacterial infection (P = 0.089). On multivariate regression, C3 hypocomplementemia at T1 was found to be associated with an increased risk for bacterial infection (OR 2.41; 95% confidence interval [CI] 1.08 - 5.34; P = 0.031) and had a nearly significant impact on the risk for any type of infection (OR 2.14; 95% CI 0.96 - 4.77; P = 0.063) in the intermediate period. Conclusions: Our study suggests that the serial measurement of complement levels during the post-transplant period provides an affordable and useful approach to the risk of infection in KT recipients.

Non-Heart Beating Donor Kidney Transplantation Is not Associated with An Increased Risk of Post-Transplant Infection

Objectives: The use of kidneys from non-heart beating donors (NHBD) has increased notably over the last years. The impact of such strategy on the risk of post-transplant infection remains unclear. Methods: We performed a prospective cohort study including 225 patients (143 males; mean age: 54.4 ± 14.1 years) who underwent kidney transplant (KT) at our institution from November 2008 to August 2010. We compared the incidence and clinical and microbiological characteristics of post-transplant infection between recipients of brain-dead donor (BDD) and NHBD grafts (154 and 71 patients, respectively). NHBD belonged mostly to categories I and II of the Maastricht classification (uncontrolled donnors). All patients in the NHBD group received induction therapy with antithymocyte globulin (ATG) and antiviral prophylaxis (mainly valganciclovir) during the first 3 months. Multivariate adjusted odds ratios (ORs) for infection were calculated using those covariates found to be significant at P < 0.10 by univariate analysis. Results: As compared to patients in the BDD group, those in the NHBD group were younger (P < 0.001), had fewer years on pre-transplant dialysis (P = 0.004), shorter cold-ischemia times (P < 0.001), and higher number of HLA mismatches (P = 0.052). Delayed graft function (requirement for dialysis within the first week after transplantation) was more frequent in the NHBD group (84.5% vs. 52.6%; P < 0.001), as well as donor/recipient cytomegalovirus (CMV) mismatch (12.7% vs. 5,8%; P = 0.079). Incidence rates of overall infection in the NHBD and BDD groups were 1.94 and 3.25 episodes per 1,000 transplant-days, respectively (P < 0.0001). Incidence rate of early infection (during the first month) was also lower in the NHBD group than in the BDD group (8.4 vs. 14.12 episodes per 1,000 transplant-days, respectively; P = 0.006). Patients in the NHBD group exhibited lower cumulative incidences of bacterial infection (P = 0.044), acute graft pyelonephritis (P = 0.081), CMV infection (P = 0.016), and non-CMV viral infection (P = 0.028). We found no differences in the incidence of other types of infection. On the regression model, and after adjusting for age, induction therapy, and cold-ischemia time, among other variables, the receipt of a NHBD graft did not remain as an independent risk factor for post-transplant infection (OR 0.63; 95% CI 0.35-1.15; P = 0.191). Conclusion: In our experience, and despite the higher occurrence of delayed graft function and CMV mismatch and the universal use of ATG induction, KT from uncontrolled NHBD does not entail an increased risk of post-transplant infection.