Variations in rates of nosocomial infection among Canadian neonatal intensive care units may be practice-related

Aziz, Khalid; McMillan, Douglas; Andrews, Wayne; Pendray, Margaret; Qiu, Zhenguo; Karuri, Stella W.; Lee, Shoo K.

doi:10.1186/1471-2431-5-22

Cited by 92 publications

(62 citation statements)

References 19 publications

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“…These findings are consistent with the results of previous larger studies of late-onset sepsis in VLBW infants (3,10,31) that demonstrated CONS in 14 to 23% of patients and S. aureus in 1.6 to 5% of patients. The majority (63%) of sepsis cases caused by CONS in this study were confirmed by two or more peripheral blood cultures growing CONS.…”

Section: Discussionsupporting

confidence: 83%

Phase 1/2 Double-Blind, Placebo-Controlled, Dose Escalation, Safety, and Pharmacokinetic Study of Pagibaximab (BSYX-A110), an Antistaphylococcal Monoclonal Antibody for the Prevention of Staphylococcal Bloodstream Infections, in Very-Low-Birth-Weight Neonates

Weisman

Thackray²,

Garcia‐Prats

et al. 2009

Antimicrob Agents Chemother

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Staphylococcal sepsis is a major cause of morbidity and mortality in very-low-birth-weight (VLBW) infants.A human chimeric monoclonal antibody, pagibaximab, was developed against staphylococcal lipoteichoic acid. We evaluated the safety, tolerability, and pharmacokinetics of pagibaximab in VLBW neonates. A phase 1/2, randomized, double-blind, placebo-controlled, dose escalation study was conducted in VLBW infants (700 to 1,300 g) 3 to 7 days old. Patients received two doses 14 days apart of intravenous pagibaximab (10, 30, 60, or 90 mg/kg of body weight) or placebo in a 2:1 ratio. Blood and urine samples were obtained pre-and postinfusion for analysis of safety and pharmacokinetics, and data on adverse events were gathered. Staphylococcal organisms causing sepsis were collected and evaluated. Fifty-three patients received at least one dose of pagibaximab or placebo. The average gestational age was 27.6 weeks; the average birth weight was 1,003 g. All serious adverse events were deemed unrelated or probably not drug related. Morbidity and mortality were similar across treatment groups. No evidence of immunogenicity of pagibaximab was detected. Pagibaximab pharmacokinetics was linear. The mean clearance (CL), volume of distribution, and elimination half-life of pagibaximab were independent of dose. The serum half-life was 20.5 ؎ 6.8 days. Pagibaximab enhanced serum opsonophagocytic activity. All staphylococci causing sepsis were opsonizable by pagibaximab. Two infusions of pagibaximab, administered 2 weeks apart to high-risk neonates appeared safe and tolerable, and pharmacokinetics were linear. Evaluation of more frequent doses, at the highest doses tested, in neonates at high-risk of staphylococcal sepsis, is warranted.Very-low-birth-weight (VLBW) neonates (Ͻ1,500-g birth weight) are at high risk for late-onset (Ͼ72 h of life) hospitalacquired sepsis (13,16,17). Such infections are a major cause of morbidity, prolong time in the hospital and intensive care unit, increase the need for antibiotics, and further increase the substantial cost of medical care for these infants (8, 17). Staphylococci, including coagulase-negative staphylococci (CONS) and Staphylococcus aureus, are responsible for between 56 and Ͼ75% of hospital-acquired, late-onset neonatal sepsis (13, 31). Recent reports (12,28,30) show continuing increases in resistance of staphylococci to antimicrobial agents. Frequent and prolonged exposures to antimicrobials have been demonstrated to increase the risk of developing infections with resistant organisms (30,34). Therapeutic products and strategies that could prevent infections would minimize the need for antimicrobial products (20).Lipoteichoic acid (LTA) is a highly conserved epitope in the staphylococcal cell wall that inhibits phagocytosis of bacteria in vitro, induces the cytokine cascade through stimulation of Tolllike receptors, and may be necessary for staphylococcal survival (18, 19, 24, 27). An anti-LTA murine/human chimeric monoclonal antibody, pagibaximab, was developed by recombinant DNA ...

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Section: Discussionsupporting

confidence: 83%

Phase 1/2 Double-Blind, Placebo-Controlled, Dose Escalation, Safety, and Pharmacokinetic Study of Pagibaximab (BSYX-A110), an Antistaphylococcal Monoclonal Antibody for the Prevention of Staphylococcal Bloodstream Infections, in Very-Low-Birth-Weight Neonates

Weisman

Thackray²,

Garcia‐Prats

et al. 2009

Antimicrob Agents Chemother

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“…The mortality rates in patients with a diagnosis of NI in the NICU was reported to be 17% in a multi-center study performed in Europe between 1996 and 1997 and 10.3% in Japan in the years between 2002 and 2003 (2.1% in patients without NI) (31,33). In a study performed in Canada in 1996-1997, the mortality rate was found to be markedly higher in patients with a diagnosis of NI (8.5%) compared to the patients without a diagnosis of NI (1.3%) among patients with a birth weight of >1500 g in the NICU, but the mortality rates were found to be 8.7% and 8.6% in patients with and without NI, respectively among patients with a birth weight of <1500 g (20). In a study performed in Germany, the mortality rate was found to be 8.1% in the patients hospitalized in the NICU; when classified according to birth weight, the mortality rate was found to be 15,2% in patients with a birth weight of <1000 g and 2,8% in patients with a birth weight of 1000-1499 (23).…”

Section: Mortality Ratementioning

confidence: 92%

“…In a study performed in 2002 in Italy, the rate of NI was reported to be 48% in infants with a birth weight of <1500 g (21). In Canada, the frequency of NI was found to range between 6.7% and 74.5% in infants with a very low birth weight and between 0.1% and 17% in infants with high birth weight in the NICU between the years of 1996 and 1997 (20). In a surveillance study performed in Germany between the years of 1994 and 1995, 61% of NIs were found to develop in patients with a birth weight of <1500 g (34).…”

Section: Nis By Birth Weightmentioning

confidence: 99%

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Yenidoğan ve yenidoğan yoğun bakım servisinde hastane enfeksiyonları

Hacımustafaoğlu¹,

Çelebi²,

Köksal³

et al. 2011

tpa

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Aim: Nosocomial infections (NI) in a neonatal intensive care unit (NICU) and neonatal clinic were evaluated during a one-year-period. Material and Method: 314 newborns were investigated for nosocomial infections. Local ethics committee approval was given for this study. Nosocomial infections was defined using the CDC criteria. Results: Nosocomial infections developed in 53% of 127 patients (58% with culture positivity) in the NICU and in 2.6% of 187 patients (all with a negative culture) in the neonatal clinic. In total, (NICU plus neonatal clinic), NI developed in 23% of hosptalized patients. Nosocomial infections rate was 42.3% and in terms of patient days, NI rate was 14/1000 patient-day. When evaluated separately, NI developed in 53.5% of patients admitted in NICU and in 2.6% of neonatal clinic patients. Also, NI rates were 17.9/1000 patient-day in NICU and 1.6/1000 patient-day in the neonatal clinic. Patients with NI stayed at the hospital for 73.6±47.8 day in NICU and for 16.0±6.7 day in the neonatal clinic. Nosocomial infections developed on the 29.4±30.9 th d in NICU and on the 7.6±2.9 th day in the neonatal clinic. In NICU, in terms of 128 NI episodes, the NI related mortality was 8.5%. 16.1% (n: 11) of the patients with NI died. They died on the 56.7±50.2 nd day of admission and on the 25.8±10.2 nd day second after NI diagnosis. There was no mortality in neonatal clinic patients. Conclusions: Our NI rates were slightly higher than the developed countries and lower than the developing countries. (Turk Arch Ped 2011; 46: 293-8)

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“…[2][3][4] Traditionally, prevention of EONS has focused on prevention of vertical transmission of group B Streptococcus (GBS or Streptococcus agalactiae) through administration of maternal intrapartum antibiotic prophylaxis. 5 No effective strategies are currently available to prevent EONS caused by other organisms, 6 such as Escherichia coli. 7 Several recent studies of patient populations in the US have reported a change in neonatal infection patterns, with a reduction in EONS caused by GBS but an increase in EONS caused by ampicillin-resistant E. coli.…”

Section: Introductionmentioning

confidence: 99%

Early-onset neonatal sepsis: rate and organism pattern between 2003 and 2008

et al. 2011

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Objective: Organisms causing early-onset neonatal sepsis (EONS) have consistently changed over time. The distribution of organisms in EONS helps to influence the appropriate type of antibiotic prophylaxis strategy during labor and the antibiotics used in neonates with suspected sepsis. Result: A total of 405 infants had positive blood and/or cerebral spinal fluid cultures over the study period. The EONS rate was 6.8/1000 admissions (n ¼ 24969) in the earlier cohort compared with 6.2/1000 admissions (n ¼ 37484) in the later cohort (P ¼ 0.36). Rate of clinical chorioamnionitis was higher in the later cohort (38 vs 26%; P ¼ 0.02). For term infants, coagulase-negative Staphylococcus (CONS) (2.4/1000) followed by group B Streptococcus (GBS) (1.9/1000) were the most common organisms identified. For preterm infants, CONS (2.5/1000) followed by Escherichia coli (2.6/1000) were the most common organisms identified. There was a significant reduction in GBS EONS over time (P<0.01) and a trend toward an increase in other organisms. Conclusion:Although the rate of EONS among neonates admitted to NICUs has not changed, the pattern of infection has changed over the past 6 years. With the increased use of prophylactic antibiotics to mothers, careful surveillance of the changing trend of bacterial organisms among neonates is warranted. (2011) Introduction Early-onset neonatal sepsis (EONS) occurs within the first 3 to 7 days of life, and is thought to be mainly caused by vertical transmission of organisms from the mother. 1,2 The incidence of EONS has been reported to vary from 1 to 4.6 cases per 1000 live births. [2][3][4] Traditionally, prevention of EONS has focused on prevention of vertical transmission of group B Streptococcus (GBS or Streptococcus agalactiae) through administration of maternal intrapartum antibiotic prophylaxis. 5 No effective strategies are currently available to prevent EONS caused by other organisms, 6 such as Escherichia coli. 7 Several recent studies of patient populations in the US have reported a change in neonatal infection patterns, with a reduction in EONS caused by GBS but an increase in EONS caused by ampicillin-resistant E. coli. 8,9 The growing problem of antibiotic resistance may be a contributing factor in increasing mortality rates of infants with EONS. 2,10 These studies have identified an urgent need to better understand the changing epidemiology of EONS, to enable delivery of appropriate intrapartum care to mothers 8,11 and postnatal care of the newborns. We have therefore analyzed data from a large population of infants admitted to Canadian neonatal intensive care units (NICUs) between 2003 and 2008, to identify trends in EONS, and determine the distribution of organisms in infants with EONS. The objective of this study was to add to our understanding of changing patterns of organisms associated with EONS, thereby helping to strategize future interventions. Journal of Perinatology Methods Study populationThe Canadian Neonatal Network (CNN) maintains and updates an established neonata...

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Variations in rates of nosocomial infection among Canadian neonatal intensive care units may be practice-related

Cited by 92 publications

References 19 publications

Phase 1/2 Double-Blind, Placebo-Controlled, Dose Escalation, Safety, and Pharmacokinetic Study of Pagibaximab (BSYX-A110), an Antistaphylococcal Monoclonal Antibody for the Prevention of Staphylococcal Bloodstream Infections, in Very-Low-Birth-Weight Neonates

Phase 1/2 Double-Blind, Placebo-Controlled, Dose Escalation, Safety, and Pharmacokinetic Study of Pagibaximab (BSYX-A110), an Antistaphylococcal Monoclonal Antibody for the Prevention of Staphylococcal Bloodstream Infections, in Very-Low-Birth-Weight Neonates

Yenidoğan ve yenidoğan yoğun bakım servisinde hastane enfeksiyonları

Early-onset neonatal sepsis: rate and organism pattern between 2003 and 2008

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