Marian G Michaels

UPMC, Pittsburgh, Pennsylvania, United States

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Publications (136)622.18 Total impact

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    ABSTRACT: Congenital CMV infection is traditionally diagnosed byvirus detection in saliva or urine. Virus culture was positive in significantly fewer urine samples collected using cotton balls in diapers (54.2%) than with samples collected by bags (95.7%) from newborns screened positive for CMV in saliva. However, PCR was positive in 95% of urine samples regardless of the collection method.
    The Pediatric Infectious Disease Journal 05/2015; DOI:10.1097/INF.0000000000000757 · 3.14 Impact Factor
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    ABSTRACT: As part of the CMV and Hearing Multicenter Screening (CHIMES) study, 72,239 newborns were screened for cytomegalovirus by rapid culture and real-time PCR of saliva samples. Of the 266 infants with congenital cytomegalovirus infection, discordance between rapid culture and PCR was observed in 14 children, and 13 were identified only by PCR, demonstrating the superiority of the PCR assay.
    The Pediatric Infectious Disease Journal 05/2015; 34(5):536-7. DOI:10.1097/INF.0000000000000609 · 3.14 Impact Factor
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    ABSTRACT: The treatment of symptomatic congenital cytomegalovirus (CMV) disease with intravenous ganciclovir for 6 weeks has been shown to improve audiologic outcomes at 6 months, but the benefits wane over time. We conducted a randomized, placebo-controlled trial of valganciclovir therapy in neonates with symptomatic congenital CMV disease, comparing 6 months of therapy with 6 weeks of therapy. The primary end point was the change in hearing in the better ear ("best-ear" hearing) from baseline to 6 months. Secondary end points included the change in hearing from baseline to follow-up at 12 and 24 months and neurodevelopmental outcomes, with each end point adjusted for central nervous system involvement at baseline. A total of 96 neonates underwent randomization, of whom 86 had follow-up data at 6 months that could be evaluated. Best-ear hearing at 6 months was similar in the 6-month group and the 6-week group (2 and 3 participants, respectively, had improvement; 36 and 37 had no change; and 5 and 3 had worsening; P=0.41). Total-ear hearing (hearing in one or both ears that could be evaluated) was more likely to be improved or to remain normal at 12 months in the 6-month group than in the 6-week group (73% vs. 57%, P=0.01). The benefit in total-ear hearing was maintained at 24 months (77% vs. 64%, P=0.04). At 24 months, the 6-month group, as compared with the 6-week group, had better neurodevelopmental scores on the Bayley Scales of Infant and Toddler Development, third edition, on the language-composite component (P=0.004) and on the receptive-communication scale (P=0.003). Grade 3 or 4 neutropenia occurred in 19% of the participants during the first 6 weeks. During the next 4.5 months of the study, grade 3 or 4 neutropenia occurred in 21% of the participants in the 6-month group and in 27% of those in the 6-week group (P=0.64). Treating symptomatic congenital CMV disease with valganciclovir for 6 months, as compared with 6 weeks, did not improve hearing in the short term but appeared to improve hearing and developmental outcomes modestly in the longer term. (Funded by the National Institute of Allergy and Infectious Diseases; ClinicalTrials.gov number, NCT00466817.).
    New England Journal of Medicine 03/2015; 372(10):933-43. DOI:10.1056/NEJMoa1404599 · 54.42 Impact Factor
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    ABSTRACT: Children who have undergone SOT mount a lower immune response after vaccination with TIV compared to healthy controls. HD or SD TIV in pediatric SOT was given to subjects 3–17 yr and at least six months post-transplant. Subjects were randomized 2:1 to receive either the HD (60 μg) or the SD (15 μg) TIV. Local and systemic reactions were solicited after each vaccination, and immune responses were measured before and after each vaccination. Thirty-eight subjects were enrolled. Mean age was 11.25 yr; 68% male, 45% renal, 26% heart, 21% liver, 5% lung, and 5% intestinal. Twenty-three subjects were given HD and 15 SD TIV. The median time since transplant receipt was 2.2 yr. No severe AEs or rejection was attributed to vaccination. The HD group reported more tenderness and local reactions, fatigue, and body ache when compared to the SD cohort, but these were considered mild and resolved within three days. Subjects in the HD group demonstrated a higher percentage of four-fold titer rise to H3N2 compared to the SD group. HD influenza vaccine was well tolerated and may have increased immunogenicity. A phase 2 trial is needed to confirm.
    Pediatric Transplantation 12/2014; 19(2). DOI:10.1111/petr.12419 · 1.63 Impact Factor
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    ABSTRACT: Background: Congenital CMV infection (cCMV) is a common congenital infection and a significant contributor to non-genetic sensorineural hearing loss (SNHL). Real-time PCR of newborn saliva specimens has been shown to be highly sensitive and specific compared to culture based methods for CMV screening. Although both saliva and urine samples are known to be acceptable for identifying infants with cCMV, it is thought that urine samples may contain more virus and thus, are optimal for cCMV screening. The objective is to compare viral load (VL) levels between saliva and urine samples from a large cohort of infants with cCMV infection identified through a newborn screening program. Methods: As part of the NIDCD CHIMES study, newborns at 7 U.S. medical centers were screened for CMV by saliva and dried blood spot PCR. Infants who screened positive were enrolled in a follow-up study to confirm congenital infection by testing saliva and urine samples using a previously described real-time PCR assay. CMV viral load in saliva samples obtained at screening and enrollment was compared to urine collected at enrollment in follow-up. Results: Of the 100,332 newborns screened for CMV from 2007 to 2011, viral load levels in both saliva and urine samples were available in 73% (336/462) of infants with confirmed cCMV. Of these, 36% (121/336) were enrolled within the first 3 weeks of life. The median viral load level in saliva at screening and enrollment (2.x106 IU/ml and 1.1x107 IU/ml, respectively) was significantly higher than in urine (8.3x105 IU/ml; p < 0.0001). There was no significant difference between VL in saliva and urine in infants with and without symptomatic disease and with and without congenital SNHL. In the smaller cohort of infants enrolled within 3 weeks of birth, median saliva VL at screening and enrollment (1.1x106 IU/ml vs. 9.3x106 IU/ml, respectively) was higher than urine VL (7.9x105IU/ml; p < 0.0001) . Conclusion: Infants with congenital CMV infection shed large amounts of virus in both saliva and urine. However, saliva samples contained higher viral load than urine, are easier to collect and do not require DNA extraction. Therefore, we propose that saliva should be considered the ideal specimen and real-time PCR of saliva is appropriate for both newborn screening and diagnosis of cCMV.
    IDWeek 2014 Meeting of the Infectious Diseases Society of America; 10/2014
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    ABSTRACT: Background: Neonatal enterovirus (EV) infections have high morbidity & mortality. Antiviral therapy is not currently available. Pleconaril is an oral capsid binder with activity against EVs. Methods: Neonates with suspected EV sepsis (hepatitis, coagulopathy, or myocarditis) were randomized 2:1 to receive oral pleconaril or placebo x 7 days. Specimens (oropharynx, rectum, urine, serum) for viral culture & polymerase chain reaction (PCR), pharmacokinetic analysis, & safety evaluations were obtained over 14 days & clinical assessments were performed over 24 months. Results: 61 subjects were enrolled (43 treatment, 18 placebo), of whom 43 were confirmed EV-infected by culture or PCR (31 treatment, 12 placebo). Baseline characteristics were similar between EV-infected groups; median (range) age at illness onset was 4.5 (1-15) & 5.0 (1-10) days, respectively. Low culture yields precluded demonstrating a difference in the primary endpoint, day 5 oropharyngeal culture positivity (25% positive on Day 1 & 0% on Day 5 in the treatment group v. 30% on Day 1 & 0% on Day 5 in the placebo group). However, subjects in the treatment group became culture-negative from all anatomic sites combined faster than subjects in the placebo group (Fig 1; median 4.0 v. 7.0 days, p = 0.08) & fewer subjects in the treatment group remained PCR-positive from the oropharynx when last sampled (83% positive on Day 1 & 23% positive at a median of 14 days in the treatment group v. 100% positive on Day 1 & 58% positive at a median of 14 days in the placebo group, p = 0.02). By intent to treat, 10/43 (23%) of all subjects in the treatment group & 8/18 (44%) in the placebo group died (Fig 2; p = 0.02 for 2 month survival difference). Among EV-confirmed subjects, 7/31 (23%) in the treatment group died v. 5/12 (42%) in the placebo group (Fig 3; p = 0.26). Pleconaril concentrations exceeded the IC90 after the first treatment day, but 41% of subjects did not achieve this targetduring the 1st treatment day. 1 subject in the treatment group & 3 in the placebo group had treatment-related adverse events. Conclusion: Shorter times to culture & PCR negativity & suggestion of greater survival among pleconaril recipients support potential efficacy & warrant further evaluation. SEQ Figure * ARABIC 1. Culture positive SEQ Figure * ARABIC 2. Survival, all subjects SEQ Figure * ARABIC 3. Survival, EV-confirmed
    IDWeek 2014 Meeting of the Infectious Diseases Society of America; 10/2014
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    ABSTRACT: Transplant infectious diseases is a rapidly emerging subspecialty within pediatric infectious diseases reflecting the increasing volumes and complexity of this patient population. Incorporating transplant infectious diseases into the transplant process would provide an opportunity to improve clinical outcome and advocacy as well as expand research. The relationship between transplant physicians and infectious diseases (ID) specialists is one of partnership, collaboration, and mutual continuing professional education. The ID CARE Committee of the International Pediatric Transplant Association (IPTA) views the development and integration of transplant infectious diseases into pediatric transplant care as an international priority.
    Pediatric Transplantation 09/2014; 18(8). DOI:10.1111/petr.12355 · 1.63 Impact Factor
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    ABSTRACT: Fungal infections create a significant risk to pediatric lung transplant recipients. However, no international consensus guidelines exist for fungal infection prevention strategies. It was the aim to describe the current strategies of antifungal prophylaxis in pediatric lung transplant centers. A self-administered, web-based survey on current practices to prevent fungal infection was circulated to centers within the IPLTC. Twenty-one (88%) IPLTC centers participated, predominantly from Europe and the US. More than 50% of respondents perform adult and pediatric lung transplant operations. Twenty-four percent use universal prophylaxis, 28% give prophylaxis to all patients but stratify the antifungal coverage based on pretransplant risk, and 48% target prophylaxis to only the children with CF or pretransplantation fungal colonization. Commonly, centers aim to target Aspergillus and Candida infection. Monotherapy with either voriconazole or inhaled amphotericin B is used in the majority of centers. Institutions utilize prophylactic therapy for variable time periods (40% 3–6 months; 30% ≥12 months). Alternative drugs were prescribed for lack of tolerance, toxicity, or positive surveillance culture. TDM (itraconazole/voriconazole) was used in 86% of centers. The survey revealed a wide range of antifungal prophylaxis strategies as current international practice in pediatric lung transplant recipients.
    Pediatric Transplantation 06/2014; 18(4). DOI:10.1111/petr.12263 · 1.63 Impact Factor
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    ABSTRACT: Viral culture of urine or saliva has been the gold standard for the diagnosis of congenital CMV infection. Results of rapid culture and PCR of urine and saliva from 80 children were compared to determine the utility of a real-time PCR assay for congenital CMV diagnosis. Urine PCR was positive in 98.8% of specimens. Three PCR-positive urine samples were culture-negative. Saliva PCR and culture were concordant in 78 specimens (97.5%). Two PCR-positive saliva samples were culture-negative. PCR of urine or saliva is equivalent to rapid culture for congenital CMV diagnosis. Additionally, saliva samples are easier to collect than urine.
    The Journal of Infectious Diseases 05/2014; 210(9). DOI:10.1093/infdis/jiu263 · 5.78 Impact Factor
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    ABSTRACT: In February 2013, the Organ Procurement and Transplantation Network mandated that transplant centers perform screening of living kidney donors prior to transplantation for Strongyloides, Trypanosoma cruzi and West Nile virus (WNV) infection if the donor is from an endemic area. However, specific guidelines for screening were not provided, such as the optimal testing modalities, timing of screening prior to donation and the appropriate selection of donors. In this regard, the American Society of Transplantation Infectious Diseases Community of Practice, together with disease-specific experts, has developed this viewpoint document to provide guidance for the testing of live donors for Strongyloides, T. cruzi and WNV infection, specifically identifying at-risk populations and testing algorithms, including advantages, limitations and interpretation of results.
    American Journal of Transplantation 03/2014; 14(5). DOI:10.1111/ajt.12666 · 6.19 Impact Factor
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    ABSTRACT: Background: Cytomegalovirus (CMV) is the leading non-genetic cause of sensorineural hearing loss (SNHL). Children with congenital CMV infection excrete CMV for a variable time period during childhood. It has been suggested that shorter duration of shedding in urine was associated with SNHL but this association remains to be confirmed. Most studies to date have examined CMV excretion patterns in urine. The objective of this study was to examine duration and the amount of salivary CMV shedding by PCR in a large cohort of children with congenital CMV infection. Methods: As part of an ongoing multicenter study (CHIMES study), infants born at seven hospitals in the U.S. were screened for congenital CMV infection. Saliva specimens collected at newborn screening, at enrollment into the follow-up study (3-6 wks), and at every 6 months up to 48 months of age were tested for CMV using real-time PCR. All CMV-infected infants underwent audiologic evaluation in early infancy. Results: Of the CMV-infected children, 102 children had virus shedding data at all follow-up visits up to 24 months of age and were included. Twenty three infants treated with gancyclovir/valgancyclovir were excluded. The cohort included 12 infants with SNHL at birth. The median duration of CMV shedding in saliva in the study subjects was 24±9.8 months. There was no significant difference in the duration of shedding for infants with and without hearing loss at birth (p = 1). There was no significant difference between viral load at birth (1.23x107 vs. 2.2x106 copies/ml) and at 24 months (4.78x102 vs. 4x102 copies/ml) between infants with and without hearing loss. Among infants with saliva PCR data available at 36 and 48 months, 54/109 (49.5%) tested positive by PCR at 36 months and 22/74 (29.7%) infants were positive at 48 months. Conclusion: Most infants with congenital CMV infection shed CMV in saliva for a median of two years after birth. There is no significant difference between duration of shedding of CMV between infants with and without SNHL at birth. There was also no significant difference in saliva viral load at birth and at 24 months of age between children with and without SNHL.
    IDWeek 2013 Meeting of the Infectious Diseases Society of America; 10/2013
  • R K Avery, M G Michaels
    American Journal of Transplantation 03/2013; 13(s4):304-310. DOI:10.1111/ajt.12121 · 6.19 Impact Factor
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    ABSTRACT: Background. Children <2 years of age are at high risk of influenza-related mortality and morbidity. However, the appropriate dose of oseltamivir for children <2 years of age is unknown. Methods. The National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group evaluated oseltamivir in infants aged <2 years in an age-de-escalation, adaptive design with a targeted systemic exposure. Results. From 2006 to 2010, 87 subjects enrolled. An oseltamivir dose of 3.0 mg/kg produced drug exposures within the target range in subjects 0-8 months of age, although there was a greater degree of variability in infants <3 months of age. In subjects 9-11 months of age, a dose of 3.5 mg/kg produced drug exposures within the target range. Six of 10 subjects aged 12-23 months receiving the Food and Drug Administration-approved unit dose for this age group (ie, 30 mg) had oseltamivir carboxylate exposures below the target range. Virus from 3 subjects developed oseltamivir resistance during antiviral treatment. Conclusions. The appropriate twice-daily oral oseltamivir dose for infants <= 8 months of age is 3.0 mg/kg, while the dose for infants 9-11 months old is 3.5 mg/kg.
    The Journal of Infectious Diseases 03/2013; 207(5):709-720. DOI:10.1093/infdis/jis765 · 5.78 Impact Factor
  • American Journal of Transplantation 03/2013; 13(s4):1-2. DOI:10.1111/ajt.12129 · 6.19 Impact Factor
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    ABSTRACT: A working group representing the American Society of Transplantation, Pediatric Infectious Diseases Society, and International Pediatric Transplant Association has developed a collaborative effort to identify and develop core knowledge in pediatric transplant infectious diseases. Guidance for patient care environments for training and core competencies is included to help facilitate training directed at improving the experience for pediatric infectious diseases trainees and practitioners in the area of pediatric transplant infectious diseases.
    02/2013; 4(1). DOI:10.1093/jpids/pit079
  • M. Green, M. G. Michaels
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    ABSTRACT: Epstein–Barr virus (EBV) is an important pathogen in recipients of solid organ transplants (SOT). Infection with EBV manifests as a spectrum of diseases/malignancies ranging from asymptomatic viremia through infectious mononucleosis to posttransplant lymphoproliferative disorder (PTLD). EBV disease and its associated PTLD is more frequently seen when primary EBV infection occurs after transplant, a common scenario in pediatric SOT recipients. Intensity of immunosuppressive therapies also influences the risk for PTLD. The use of EBV viral load monitoring facilitates the diagnosis and management of EBV/PTLD as well as being used to inform preemptive therapy with reduction of immunosuppression, the most effective intervention for prevention of and treatment for PTLD. Other therapies, including the rituximab (anti‐CD20 monoclonal antibody) and traditional chemotherapy, are also useful in the treatment of established PTLD. The future development of standards for management based on EBV viral load and routine monitoring of EBV‐specific CTL responses promise further improvement in outcomes with EBV and PTLD.
    American Journal of Transplantation 02/2013; 13(s3). DOI:10.1111/ajt.12004 · 6.19 Impact Factor
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    ABSTRACT: Background. Children under 2 years of age are at high risk of influenza-related mortality and morbidity. However, the appropriate dose of oseltamivir for children under 2 years of age is unknown.Methods. The National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group evaluated oseltamivir in infants from birth to 2 years of age in an age-deescalation, adaptive design with a targeted systemic exposure.Results. From 2006 to 2010, 87 subjects enrolled. An oseltamivir dose of 3.0&emsp14;mg/kg produced drug exposures within the target range in subjects 0 through 8 months of age, although there was a greater degree of variability in infants under 3 months of age. In subjects 9 through 11 months of age, a dose of 3.5&emsp14;mg/kg produced drug exposures within the target range. Six of ten subjects 12 through 23 months of age receiving the FDA-approved unit dose for this age group of 30&emsp14;mg had oseltamivir carboxylate exposures below the target range. Virus from three subjects developed oseltamivir resistance during antiviral treatment.Conclusions. The appropriate twice-daily oral oseltamivir dose for infants birth through 8 months of age is 3.0&emsp14;mg/kg, while the dose for infants 9 through 11 months is 3.5&emsp14;mg/kg.
    The Journal of Infectious Diseases 12/2012; 207. · 5.78 Impact Factor
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    ABSTRACT: Background: Although children who have undergone SOT mount an immune response after vaccination with TIV, these responses are lower compared to controls. Methods: This was a randomized, double-blind, phase I safety and immunogenicity trial comparing HD to SD TIV in pediatric SOT patients aged 3-17 years and at least six months after transplant. Subjects were randomized 2:1 to receive either 0.5mL of HD (60ug per antigen) or SD (15ug per antigen) 2011-2012 TIV. Local and systemic reactions were collected for seven days after each vaccination. HAI titers to influenza virus antigens were measured before and 28-42 days after vaccination. Complete blood count; quantitative CD4, CD8, and CD19; and serum IgG were also collected. Results: Thirty-eight subjects were enrolled. Mean age was 11.25 years; 68% male; 45% renal, 26% heart, 21% liver, 5% lung, and 5% intestinal. Twenty-three were given HD and 15 SD TIV. Average time since transplant was 7.4 years. No individuals had rejection associated with vaccination. Thirty-seven subjects were given one dose of vaccine. Table 1. Safety Parameters. Safety HD SD P value Any local 83% (19/23) 50% (7/14) 0.035 Any systemic 43% (10/23) 21% (3/14) 0.17 Temp >100.5 17% (4/23) 7% (1/14) 0.38 Table 2. Immunogenicity Results H1N1 A/California/7/09 H3N2 A/Perth/16/2009 H1N1 B/Brisbane/60/2008 HD SD P value HD SD P value HD SD P value >1:40 100% (23/23) 100% (15/15) 1 96% (22/23) 100% (15/15) 0.41 91% (21/23) 93% (14/15) 0.82 >4-fold rise 61% (14/23) 40% (6/15) 0.21 61% (14/23) 20% (3/15) 0.013 57% (13/23) 40% (6/15) 0.32 GMT Visit 1 52.5 [38.8, 71.0] 66.5 [45.7, 96.7] 54.1 [34.1, 85.7] 127.0 [71.8, 224.7] 59.2 [31.0, 113] 133.0 [59.8, 296] GMT Visit 2 184 [87.1, 388] 372 [203.6, 680] 230 [117, 452] 232 [100, 535] 230 [121, 435] 306 [139, 673] Conclusion: No differences were noted between the HD and SD groups for solicited systemic reactions. Local reactions were reported more in the HD group compared to the SD. Subjects in the HD group had a higher percentage of 4-fold rise to H3N2 compared to the SD group. These data support the need for a phase II trial.
    IDWeek 2012 Meeting of the Infectious Diseases Society of America; 10/2012
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    ABSTRACT: Background: Background: Antimicrobial Stewardship Programs (ASP) help to improve appropriate antibiotic use , decrease the rate of resistant organisms thereby increasing patient safety. The 2007 Infectious Diseases Society of America (IDSA) guidelines for implementing ASP included use of a dedicated clinical pharmacist trained in infectious diseases (ID) & ID physician. The presence of “team-based” clinical pharmacists at our institution led us to implement an alternative model of ASP using a “team” approach of clinical pharmacists & ID physicians. Methods: Methods: Dedicated pharmacy specialists round with individual services in the hospital. Protocols were developed for 3 targeted antimicrobial agents (vancomycin, caspofungin and meropenem) with approval by high use services. A daily data warehouse report informed of a day 3 prospective review by the clinical pharmacists on their respective units, the on call pharmacist for other units & ID physicians on weekends and holidays. ASP recommendations were made to continue, stop or modify therapy based on clinical status, laboratory results & microbiology reports. Recommendations were entered into the electronic medical record and communicated to the primary physicia Results: Over a 2 yr period, there was a decrease in the number of drug days for vancomycin, meropenem and overall antifungal use by 26%, 60% and 48%, respectively. With vancomycin alone, there was a 32% decline in vancomycin doses given per quarter with a 21% decline in total “grams” dispensed. A decrease in vancomycin prescribing was noted by all services within the hospital; Pediatric Intensive Care showing the biggest reduction in usage and the Hematology/Oncology service with the least impact. A 3 month review of Day 3 ASP recommendations demonstrated a compliance rate of 90%, 93% and 100% for vancomycin, caspofungin & meropenem, respectively. Conclusion: This non-traditional ASP model had a positive impact in reducing use of targeted drugs particularly for units with dedicated clinical pharmacists, demonstrating acceptance of this integration of service-based clinical pharmacist and ID consultants in this unique model. Further data are needed to assess whether the program has been able to show a decrease in the rate of resistant organis
    IDWeek 2012 Meeting of the Infectious Diseases Society of America; 10/2012
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    ABSTRACT:   Invasive fungal infections in children have increased in recent years, coinciding with greater survival of preterm neonates and children with immunodeficiencies, more intense chemotherapy regimens, and greater use of stem cell and solid organ transplantation. We describe a case of an immunosuppressed neonate who developed cutaneous Exserohilum rostratum infection.
    Pediatric Dermatology 09/2012; 30(6). DOI:10.1111/j.1525-1470.2012.01829.x · 1.52 Impact Factor

Publication Stats

3k Citations
622.18 Total Impact Points

Institutions

  • 2011–2014
    • UPMC
      Pittsburgh, Pennsylvania, United States
  • 1994–2014
    • University of Pittsburgh
      • • Department of Pediatrics
      • • Division of Infectious Diseases
      • • Department of Orthopaedic Surgery
      • • Department of Medicine
      Pittsburgh, Pennsylvania, United States
  • 1992–2014
    • Childrens Hospital of Pittsburgh
      • • Division of Pediatric Infectious Diseases
      • • Department of Pediatrics
      Pittsburgh, Pennsylvania, United States
  • 2012
    • University of Alabama at Birmingham
      • Department of Pediatrics
      Birmingham, AL, United States
  • 2009
    • Boston Children's Hospital
      • Division of Nephrology
      Boston, Massachusetts, United States