Marian G Michaels

Johns Hopkins University, Baltimore, Maryland, United States

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Publications (110)518.37 Total impact

  • [Show abstract] [Hide abstract]
    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). · 1.50 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; · 5.85 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; · 6.19 Impact Factor
  • American Journal of Transplantation 03/2013; 13(s4):1-2. · 6.19 Impact Factor
  • R K Avery, M G Michaels
    American Journal of Transplantation 03/2013; 13(s4):304-310. · 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 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 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 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 mg/kg, while the dose for infants 9 through 11 months is 3.5 mg/kg.
    The Journal of Infectious Diseases 12/2012; · 5.85 Impact Factor
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    ABSTRACT: Mycobacterium tuberculosis is a ubiquitous organism that infects one-third of the world's population. In previous decades, access to organ transplantation was restricted to academic medical centers in more developed, low tuberculosis (TB) incidence countries. Globalization, changing immigration patterns, and the expansion of sophisticated medical procedures to medium and high TB incidence countries have made tuberculosis an increasingly important posttransplant infectious disease. Tuberculosis is now one of the most common bacterial causes of solid-organ transplant donor-derived infection reported in transplant recipients in the United States. Recognition of latent or undiagnosed active TB in the potential organ donor is critical to prevent emergence of disease in the recipient posttransplant. Donor-derived tuberculosis after transplantation is associated with significant morbidity and mortality, which can best be prevented through careful screening and targeted treatment. To address this growing challenge and provide recommendations, an expert international working group was assembled including specialists in transplant infectious diseases, transplant surgery, organ procurement and TB epidemiology, diagnostics and management. This working group reviewed the currently available data to formulate consensus recommendations for screening and management of TB in organ donors.
    American Journal of Transplantation 08/2012; 12(9):2288-300. · 6.19 Impact Factor
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    ABSTRACT: Concern over the rise of vaccine preventable diseases (VPD) coupled with the increasing popularity of homeschooling makes understanding the attitudes and behaviors of homeschoolers regarding immunizations a critical area of investigation. This study was a pilot to investigate the immunization attitudes of homeschooling parents and the vaccination status of their children. In the spring of 2010, online surveys were sent to a convenience sample of 707 homeschooling parents in Western Pennsylvania with children ages 0-18 years of age. Information was collected on demographic characteristics, vaccination status of children, and attitudes toward vaccination. Surveys were returned by 18 percent of respondents, representing 396 homeschooled children. Demographic characteristics mirrored national homeschooling trends. The majority (95%) surveyed felt that education about vaccines was important. Thirty-eight percent of families had fully vaccinated children while 56% reported partial vaccination and 6% said children had received no vaccines. Respondents who fully vaccinated their children were more likely to agree that vaccinating according to the American Academy of Pediatrics was a good idea (OR: 4.8 [95% CI: 2.0-11.7]) and were more likely to comply with the recommendations of their health care provider (OR: 8.3 [95% CI: 3.6-19.1]). Respondents who vaccinated their children were more likely to believe that vaccines are safe (OR: 7.6 [95% CI: 1.0-56.2]). Beliefs about autism, thimerosal and learning disabilities did not vary significantly with vaccination status in regression analysis. While specific factors influencing vaccination practices were not identified, this study demonstrated that recommendations of physicians and the AAP do not significantly influence homeschooling vaccination practices in the pilot population. Given the results of this pilot study, more research is called for, particularly a larger study with public school controls.
    Vaccine 12/2011; 30(6):1149-53. · 3.77 Impact Factor
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    ABSTRACT: Influenza virus causes a spectrum of illness in transplant recipients with a high rate of lower respiratory disease. Seasonal influenza vaccination is an important public health measure recommended for transplant recipients and their close contacts. Vaccine has been shown to be safe and generally well tolerated in both adult and pediatric transplant recipients. However, responses to vaccine are variable and are dependent on various factors including time from transplantation and specific immunosuppressive medication. Seasonal influenza vaccine has demonstrated safety and no conclusive evidence exists for a link between vaccination and allograft dysfunction. Annually updated trivalent inactivated influenza vaccines have been available and routinely used for several decades, although newer influenza vaccination formulations including high-dose vaccine, adjuvanted vaccine, quadrivalent inactivated vaccine and vaccine by intradermal delivery system are now available or will be available in the near future. Safety and immunogenicity data of these new formulations in transplant recipients requires investigation. In this document, we review the current state of knowledge on influenza vaccines in transplant recipients and make recommendations on the use of vaccine in both adult and pediatric organ transplant recipients.
    American Journal of Transplantation 10/2011; 11(10):2020-30. · 6.19 Impact Factor
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    ABSTRACT: Cytomegalovirus (CMV), the most common cause of congenital infection, exhibits extensive genetic variability. We sought to determine whether multiple CMV strains can be transmitted to the fetus and to describe the distribution of genotypes in the saliva, urine, and blood. Study subjects consisted of a convenience sampling of 28 infants found to be CMV-positive on newborn screening as part of an ongoing study. Genotyping was performed on saliva specimens obtained during newborn screening and urine, saliva, and blood obtained at a later time point within the first 3 weeks of life. Six (21.4%) of the 28 saliva samples obtained within the first 2 days of life contained >1 CMV genotype. Multiple CMV genotypes were found in 39% (5/13) of urine, saliva, and blood samples obtained within the first 3 weeks of life from 13 of the 28 newborns. There was no predominance of a CMV genotype at a specific site; however, 4 infants demonstrated distinct CMV strains in different compartments. Infection with multiple CMV strains occurs in infants with congenital CMV infection. The impact of intrauterine infection with multiple virus strains on the pathogenesis and long-term outcome remains to be elucidated.
    The Journal of Infectious Diseases 10/2011; 204(7):1003-7. · 5.85 Impact Factor
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    Erik Su, Kelli Crowley, Joseph A Carcillo, Marian G Michaels
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    ABSTRACT: Linezolid administration has been associated with lactic acidosis in adults; however, the same phenomenon has not been reported in children. Mitochondrial protein synthesis inhibition is a demonstrated mechanism for toxicity, which therefore may manifest as lactic acidosis. Three cases of linezolid-associated lactic acidosis in children are reported to reinforce the need for pediatric caregivers to be vigilant of this potential side effect.
    The Pediatric Infectious Disease Journal 09/2011; 30(9):804-6. · 3.57 Impact Factor
  • Upton D Allen, Marian G Michaels
    Pediatric Transplantation 08/2011; 15(5):445-8. · 1.50 Impact Factor
  • Marsha Y Russell, April Palmer, Marian G Michaels
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    ABSTRACT: Disease caused by cytomegalovirus (CMV) infection can clinically manifest in a variety of ways in the immunodeficient host and lead to significant morbidity and mortality. Infections can be primary, occur as a result of reactivation of latent virus, or infection with a new strain of CMV. Cell-mediated immunity is the main defense against CMV disease. This component of the immune system is frequently affected in children who are born prematurely, have undergone solid organ transplantation or hematopoietic stem cell transplantation, or have infection with human immunodeficiency virus. Accordingly, these children are at increased risk for severe disease due to CMV. In addition, CMV itself alters cell-mediated immunity and may predispose hosts to other bacterial, fungal, or viral infections as well as predispose to graft rejection. The importance of CMV in these special populations of children, emphasizing epidemiology, risk factors, and preventive strategies, is reviewed.
    Infectious disorders drug targets. 06/2011; 11(5):437-48.
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    ABSTRACT: Congenital cytomegalovirus (CMV) infection is an important cause of hearing loss, and most infants at risk for CMV-associated hearing loss are not identified early in life because of failure to test for the infection. The standard assay for newborn CMV screening is rapid culture performed on saliva specimens obtained at birth, but this assay cannot be automated. Two alternatives--real-time polymerase-chain-reaction (PCR)-based testing of a liquid-saliva or dried-saliva specimen obtained at birth--have been developed. In our prospective, multicenter screening study of newborns, we compared real-time PCR assays of liquid-saliva and dried-saliva specimens with rapid culture of saliva specimens obtained at birth. A total of 177 of 34,989 infants (0.5%; 95% confidence interval [CI], 0.4 to 0.6) were positive for CMV, according to at least one of the three methods. Of 17,662 newborns screened with the use of the liquid-saliva PCR assay, 17,569 were negative for CMV, and the remaining 85 infants (0.5%; 95% CI, 0.4 to 0.6) had positive results on both culture and PCR assay. The sensitivity and specificity of the liquid-saliva PCR assay were 100% (95% CI, 95.8 to 100) and 99.9% (95% CI, 99.9 to 100), respectively, and the positive and negative predictive values were 91.4% (95% CI, 83.8 to 96.2) and 100% (95% CI, 99.9 to 100), respectively. Of 17,327 newborns screened by means of the dried-saliva PCR assay, 74 were positive for CMV, whereas 76 (0.4%; 95% CI, 0.3 to 0.5) were found to be CMV-positive on rapid culture. Sensitivity and specificity of the dried-saliva PCR assay were 97.4% (95% CI, 90.8 to 99.7) and 99.9% (95% CI, 99.9 to 100), respectively. The positive and negative predictive values were 90.2% (95% CI, 81.7 to 95.7) and 99.9% (95% CI, 99.9 to 100), respectively. Real-time PCR assays of both liquid- and dried-saliva specimens showed high sensitivity and specificity for detecting CMV infection and should be considered potential screening tools for CMV in newborns. (Funded by the National Institute on Deafness and Other Communication Disorders.).
    New England Journal of Medicine 06/2011; 364(22):2111-8. · 51.66 Impact Factor
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    ABSTRACT: Hepatitis A vaccination in early childhood has reduced hepatitis A transmission. Coadministration of hepatitis A vaccine with other childhood vaccines may assist completion of the age-appropriate immunization schedule. We assessed the immunogenicity and safety of an inactivated hepatitis A virus vaccine when coadministered with measles-mumps-rubella (MMR) and varicella vaccines in children less than 2 years of age. In this open-label, randomized, multicenter study, 3 groups of healthy children 15 months of age received either 2 doses of hepatitis A vaccine 6 to 9 months apart (n = 324), hepatitis A vaccine coadministered with MMR and varicella vaccines and a second dose of hepatitis A vaccine 6 to 9 months later (n = 462), or MMR and varicella vaccines followed 6 weeks later by 2 doses of hepatitis A vaccine 6 to 9 months apart (n = 455). Immune responses were evaluated at baseline, 31 days after the second dose of hepatitis A vaccine, and 42 days after MMR and varicella vaccine administration. Solicited, unsolicited, and serious adverse events were collected. After 2 doses of hepatitis A vaccine, nearly all subjects in all groups were seropositive (≥99%). Coadministration of hepatitis A vaccine with MMR and varicella vaccines did not impact the immunogenicity of any of the vaccines and was well tolerated. The immune response to hepatitis A vaccine and US-licensed MMR and varicella vaccines is not adversely affected when coadministered in children 15 months of age.
    The Pediatric Infectious Disease Journal 05/2011; 30(10):e179-85. · 3.57 Impact Factor
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    ABSTRACT: This study (NCT00197236) evaluated the safety and immunogenicity of a hepatitis A virus (HAV) vaccine when coadministered with diphtheria-tetanus-acellular pertussis (DTaP) and Haemophilus influenzae type b (Hib) vaccines in children 15 months of age. This was an open-labeled, multicenter study with healthy subjects enrolled and randomized (1:1:1) into 3 treatment groups. A total of 394 subjects received the first study vaccinations at 15 months of age. Group HAV (N = 135) received 2 doses of HAV vaccine 6 to 9 months apart. Group HAV+DTaP+Hib (N = 127) received HAV vaccine coadministered with DTaP and Hib vaccines and the second dose of HAV vaccine, 6 to 9 months later. Group DTaP+Hib→HAV (N = 132) received the DTaP and Hib vaccines at 15 months of age, followed by HAV vaccine 30 days later and the second dose of HAV vaccine 7 to 10 months after the DTaP+Hib vaccines. Immune responses were evaluated before the first study vaccination and 30 days after each vaccine dose. Solicited, unsolicited, and serious adverse events were collected. After 2 doses of the HAV vaccine, all subjects in the 3 groups were seropositive. The geometric mean concentration of anti-HAV antibodies ranged between 1625.1 and 1904.4 mIU/mL. Coadministration of the 3 vaccines did not impact immunogenicity of the HAV, DTaP, or Hib vaccines. Vaccines were well tolerated in all groups. A 2-dose schedule of HAV vaccine was well tolerated and immunogenic when administered to children starting at 15 months of age. Immune responses to the DTaP or Hib vaccines were similar whether they were administered alone or were coadministered with the HAV vaccine.
    The Pediatric Infectious Disease Journal 04/2011; 30(9):e164-9. · 3.57 Impact Factor
  • Marian G Michaels, Michael Green
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    ABSTRACT: Transplantation increasingly is being used as treatment for children with end-stage organ diseases, hematopoietic rescue from therapy used to treat malignancies, and as cure for primary immune deficiencies. This article reviews some of the major concepts regarding infections that complicate pediatric transplantation, highlighting differences in epidemiology, evaluation, treatment and prevention for children compared with adult recipients.
    Hematology/oncology clinics of North America 02/2011; 25(1):139-50. · 2.05 Impact Factor
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    Robert W Tolan, April Palmer, Marian G Michaels
    The Journal of pediatrics 10/2010; 157(6):1045; author reply 1045-6. · 4.02 Impact Factor
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    ABSTRACT: There are few data on the epidemiology and outcomes of influenza infection in recipients of solid-organ transplants. We aimed to establish the outcomes of pandemic influenza A H1N1 and factors leading to severe disease in a cohort of patients who had received transplants. We did a multicentre cohort study of adults and children who had received organ transplants with microbiological confirmation of influenza A infection from April to December, 2009. Centres were identified through the American Society of Transplantation Influenza Collaborative Study Group. Demographics, clinical presentation, treatment, and outcomes were assessed. Severity of disease was measured by admission to hospital and intensive care units (ICUs). The data were analysed with descriptive statistics. Proportions were compared by use of chi(2) tests. We used univariate analysis to identify factors leading to pneumonia, admission to hospital, and admission to an ICU. Multivariate analysis was done by use of a stepwise logistic regression model. We analysed deaths with Kaplan-Meier survival analysis. We assessed 237 cases of medically attended influenza A H1N1 reported from 26 transplant centres during the study period. Transplant types included kidney, liver, heart, lung, and others. Both adults (154 patients; median age 47 years) and children (83; 9 years) were assessed. Median time from transplant was 3.6 years. 167 (71%) of 237 patients were admitted to hospital. Data on complications were available for 230 patients; 73 (32%) had pneumonia, 37 (16%) were admitted to ICUs, and ten (4%) died. Antiviral treatment was used in 223 (94%) patients (primarily oseltamivir monotherapy). Seven (8%) patients given antiviral drugs within 48 h of symptom onset were admitted to an ICU compared with 28 (22.4%) given antivirals later (p=0.007). Children who received transplants were less likely to present with pneumonia than adults, but rates of admission to hospital and ICU were similar. Influenza A H1N1 caused substantial morbidity in recipients of solid-organ transplants during the 2009-10 pandemic. Starting antiviral therapy early is associated with clinical benefit as measured by need for ICU admission and mechanical ventilation. None.
    The Lancet Infectious Diseases 08/2010; 10(8):521-6. · 19.97 Impact Factor
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    ABSTRACT: Human papillomavirus (HPV) vaccine is effective against HPV types 16 and 18, which cause 70% of cervical cancers. The three-dose vaccination schedule at 0, 2, and 6 months may be inconvenient for college-aged women. This study assessed noninferiority of the immune response to an alternate vaccination schedule at 0, 2, and 12 months. Two hundred nonpregnant women, aged 18-23 years, with <5 sexual partners were randomized into standard and alternate schedules. Blood samples were drawn before dose 1 and 2-6 weeks after dose 3 and analyzed with the competitive Luminex immunoassay. Seropositives at baseline were eliminated from analyses by HPV type. Log-transformed titers were used to calculate HPV type-specific geometric mean titers (GMTs) and 95% confidence intervals (CI) for each group. Noninferiority was tested against a one-sided null hypothesis that the post-dose 3 GMT ratio of the alternate to standard schedule was < or =0.5 for each HPV type. One hundred eighty-eight women completed the study, with all 12 dropouts in the alternate schedule group (p < 0.001). Antibody responses in the alternate schedule were noninferior to the standard schedule for all vaccine types (p < 0.0001). Among the per-protocol population, GMTs (95% CI) for the alternate schedule were 4,440 (3,080-5,696), 5,688 (3,960-7,291), 12,443 (8,611-15,977), and 2,129 (1,183-3,063) for HPV types 6, 11, 16, and 18, respectively, vs. 2,153 (1,794-2,478), 1,966 (1,401-2,491), 6,218 (4,367-7,946), and 1,370 (1,167-1,553) for the standard schedule. Time between doses 2 and 3 significantly predicted final titer for all virus types (p < 0.005). For all HPV vaccine types, the GMT ratios indicated noninferiority of the alternate vaccine administration schedule at 0, 2, and 12 months. The alternate schedule may be used to expand options for the timing of the third dose in the HPV vaccine schedule.
    Journal of Women s Health 08/2010; 19(8):1441-7. · 1.42 Impact Factor

Publication Stats

2k Citations
518.37 Total Impact Points

Institutions

  • 2013
    • Johns Hopkins University
      • Department of Medicine
      Baltimore, Maryland, United States
    • Johns Hopkins Medicine
      • Division of Infectious Diseases
      Baltimore, MD, United States
  • 1992–2012
    • Childrens Hospital of Pittsburgh
      • • Division of Pediatric Infectious Diseases
      • • Department of Pediatrics
      Pittsburgh, Pennsylvania, United States
  • 2011
    • University of Alberta
      • Division of Infectious Diseases
      Edmonton, Alberta, Canada
    • University of Toronto
      • Division of Infectious Diseases
      Toronto, Ontario, Canada
  • 1992–2011
    • University of Pittsburgh
      • • Division of Infectious Diseases
      • • Division of Pediatric Infectious Diseases
      • • Department of Pediatrics
      • • Department of Orthopaedic Surgery
      • • Division of Reproductive Infectious Diseases and Immunology
      • • School of Medicine
      Pittsburgh, Pennsylvania, United States
  • 1991–2009
    • Hospital of the University of Pennsylvania
      • Department of Pediatrics
      Philadelphia, Pennsylvania, United States
  • 2008
    • Duke University Medical Center
      • Department of Pediatrics
      Durham, NC, United States
  • 2006
    • University of Texas Southwestern Medical Center
      • Department of Pediatrics
      Dallas, TX, United States
  • 1995
    • Southwest Foundation For Biomedical Research
      San Antonio, Texas, United States