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  • 1
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    Adjunctive Diagnostic Studies Completed Following Detection of Candidemia in Children: Secondary Analysis of Observed Practice From a Multicenter Cohort Study Conducted by the Pediatric Fungal Network
    Oxford University Press (OUP) ; 2023
    In:  Journal of the Pediatric Infectious Diseases Society Vol. 12, No. 9 ( 2023-09-27), p. 487-495
    Details
    In: Journal of the Pediatric Infectious Diseases Society, Oxford University Press (OUP), Vol. 12, No. 9 ( 2023-09-27), p. 487-495
    Abstract: Adjunctive diagnostic studies (aDS) are recommended to identify occult dissemination in patients with candidemia. Patterns of evaluation with aDS across pediatric settings are unknown. Methods Candidemia episodes were included in a secondary analysis of a multicenter comparative effectiveness study that prospectively enrolled participants age 120 days to 17 years with invasive candidiasis (predominantly candidemia) from 2014 to 2017. Ophthalmologic examination (OE), abdominal imaging (AbdImg), echocardiogram, neuroimaging, and lumbar puncture (LP) were performed per clinician discretion. Adjunctive diagnostic studies performance and positive results were determined per episode, within 30 days from candidemia onset. Associations of aDS performance with episode characteristics were evaluated via mixed-effects logistic regression. Results In 662 pediatric candidemia episodes, 490 (74%) underwent AbdImg, 450 (68%) OE, 426 (64%) echocardiogram, 160 (24%) neuroimaging, and 76 (11%) LP; performance of each aDS per episode varied across sites up to 16-fold. Longer durations of candidemia were associated with undergoing OE, AbdImg, and echocardiogram. Immunocompromised status (58% of episodes) was associated with undergoing AbdImg (adjusted odds ratio [aOR] 2.38; 95% confidence intervals [95% CI] 1.51–3.74). Intensive care at candidemia onset (30% of episodes) was associated with undergoing echocardiogram (aOR 2.42; 95% CI 1.51–3.88). Among evaluated episodes, positive OE was reported in 15 (3%), AbdImg in 30 (6%), echocardiogram in 14 (3%), neuroimaging in 9 (6%), and LP in 3 (4%). Conclusions Our findings show heterogeneity in practice, with some clinicians performing aDS selectively, potentially influenced by clinical factors. The low frequency of positive results suggests that targeted application of aDS is warranted.
    Type of Medium: Online Resource
    ISSN: 2048-7207
    URL: Article
    DOI: 10.1093/jpids/piad057
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2023
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  • 2
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    Comparative Effectiveness of Echinocandins vs Triazoles or Amphotericin B Formulations as Initial Directed Therapy for Invasive Candidiasis in Children and Adolescents
    Oxford University Press (OUP) ; 2021
    In:  Journal of the Pediatric Infectious Diseases Society ( 2021-08-10)
    Details
    In: Journal of the Pediatric Infectious Diseases Society, Oxford University Press (OUP), ( 2021-08-10)
    Abstract: Invasive candidiasis is the most common invasive fungal disease in children and adolescents, but there are limited pediatric-specific antifungal effectiveness data. We compared the effectiveness of echinocandins to triazoles or amphotericin B formulations (triazole/amphotericin B) as initial directed therapy for invasive candidiasis. Methods This multinational observational cohort study enrolled patients aged & gt;120 days and & lt;18 years with proven invasive candidiasis from January 1, 2014, to November 28, 2017, at 43 International Pediatric Fungal Network sites. Primary exposure was initial directed therapy administered at the time qualifying culture became positive for yeast. Exposure groups were categorized by receipt of an echinocandin vs receipt of triazole/amphotericin B. Primary outcome was global response at 14 days following invasive candidiasis onset, adjudicated by a centralized data review committee. Stratified Mantel-Haenszel analyses estimated risk difference between exposure groups. Results Seven-hundred and fifty invasive candidiasis episodes were identified. After exclusions, 541 participants (235 in the echinocandin group and 306 in the triazole/amphotericin B group) remained. Crude failure rates at 14 days for echinocandin and triazole/amphotericin B groups were 9.8% (95% confidence intervals [CI]: 6.0% to 13.6%) and 13.1% (95% CI: 9.3% to 16.8%), respectively. The adjusted 14-day risk difference between echinocandin and triazole/amphotericin B groups was −7.1% points (95% CI: −13.1% to −2.4%), favoring echinocandins. The risk difference was −0.4% (95% CI: −7.5% to 6.7%) at 30 days. Conclusions In children with invasive candidiasis, initial directed therapy with an echinocandin was associated with reduced failure rate at 14 days but not 30 days. These results may support echinocandins as initial directed therapy for invasive candidiasis in children and adolescents. Clinical Trials Registration NCT01869829.
    Type of Medium: Online Resource
    ISSN: 2048-7207
    URL: Article
    DOI: 10.1093/jpids/piab024
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2021
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  • 3
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    Multicenter Prospective Study of Biomarkers for Diagnosis of Invasive Candidiasis in Children and Adolescents
    Oxford University Press (OUP) ; 2022
    In:  Clinical Infectious Diseases Vol. 75, No. 2 ( 2022-08-25), p. 248-259
    Details
    In: Clinical Infectious Diseases, Oxford University Press (OUP), Vol. 75, No. 2 ( 2022-08-25), p. 248-259
    Abstract: Diagnosis of invasive candidiasis (IC) relies on insensitive cultures; the relative utility of fungal biomarkers in children is unclear. Methods This multinational observational cohort study enrolled patients aged & gt;120 days and & lt;18 years with concern for IC from 1 January 2015 to 26 September 2019 at 25 centers. Blood collected at onset of symptoms was tested using T2Candida, Fungitell (1→3)-β-D-glucan, Platelia Candida Antigen (Ag) Plus, and Platelia Candida Antibody (Ab) Plus assays. Operating characteristics were determined for each biomarker, and assays meeting a defined threshold considered in combination. Sterile site cultures were the reference standard. Results Five hundred participants were enrolled at 22 centers in 3 countries, and IC was diagnosed in 13 (2.6%). Thirteen additional blood specimens were collected and successfully spiked with Candida species, to achieve a 5.0% event rate. Valid T2Candida, Fungitell, Platelia Candida Ag Plus, and Platelia Candida Ab Plus assay results were available for 438, 467, 473, and 473 specimens, respectively. Operating characteristics for T2Candida were most optimal for detecting IC due to any Candida species, with results as follows: sensitivity, 80.0% (95% confidence interval, 59.3%–93.2%), specificity 97.1% (95.0%–98.5%), positive predictive value, 62.5% (43.7%–78.9%), and negative predictive value, 98.8% (97.2%–99.6%). Only T2Candida and Platelia Candida Ag Plus assays met the threshold for combination testing. Positive result for either yielded the following results: sensitivity, 86.4% (95% confidence interval, 65.1%– 97.1%); specificity, 94.7% (92.0%–96.7%); positive predictive value, 47.5% (31.5%–63.9%); and negative predictive value, 99.2% (97.7%–99.8%). Conclusions T2Candida alone or in combination with Platelia Candida Ag Plus may be beneficial for rapid detection of Candida species in children with concern for IC. Clinical Trials Registration NCT02220790.
    Type of Medium: Online Resource
    ISSN: 1058-4838 , 1537-6591
    URL: Article
    DOI: 10.1093/cid/ciab928
    RVK:
    XA 10000
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
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  • 4
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    Incidence of CMV Infection and Disease and Adverse Events Associated with Antiviral Therapy in a Retrospective Cohort of Allogeneic Hematopoietic Cell Transplant Recipients at an Academic Children’s Hospital
    Oxford University Press (OUP) ; 2021
    In:  Journal of the Pediatric Infectious Diseases Society Vol. 10, No. 9 ( 2021-10-27), p. 910-918
    Details
    In: Journal of the Pediatric Infectious Diseases Society, Oxford University Press (OUP), Vol. 10, No. 9 ( 2021-10-27), p. 910-918
    Abstract: Cytomegalovirus (CMV) is a significant source of morbidity and mortality among transplant recipients; the epidemiology is less understood in pediatric hematopoietic cell transplantation (HCT) cohorts. Furthermore, there is a paucity of data related to CMV prophylactic and preemptive strategies. Methods A single-center retrospective observational cohort of allogeneic HCT recipients at the Children’s Hospital of Philadelphia January 1, 2004–December 31, 2017 was constructed. Subjects were followed for 180 days after transplant to determine whether they had CMV infection or disease. Data on antiviral therapy were collected as were outcomes of CMV disease and adverse events (AEs) related to the antiviral therapy. Results Between January 2004 and March 2017, 345 allogeneic HCTs in 333 patients undergoing CMV surveillance testing were identified. CMV DNAemia was detected during the 180-day follow-up in 89 (25.8%) HCTs. CMV recipient-positive transplants were most likely to have CMV infection (47%). Infection rates were high for those receiving a CMV-specific prophylaxis regimen (50%). CMV DNAemia progressed to CMV disease 11.2% of the time. Of 224 subjects receiving CMV-specific prophylaxis, 19.2% experienced ≥1 AE. Of 53 receiving preemptive therapy during any CMV DNAemia episode, 32.1% experienced ≥1 AE. Conclusions CMV infection is common in pediatric allogeneic HCT recipients. The CMV-specific prophylaxis regimen employed in this cohort did not effectively prevent DNAemia, progression to CMV disease was uncommon, and AEs from prophylaxis and preemptive therapy were frequent. Novel approaches that reduce the impact of CMV on pediatric allogeneic HCT recipients are needed.
    Type of Medium: Online Resource
    ISSN: 2048-7207
    URL: Article
    DOI: 10.1093/jpids/piab041
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2021
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  • 5
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    1745. Retrospective Cohort Analysis to Determine the Incidence of CMV Infection and Disease in Allogeneic Hematopoietic Cell Transplant Recipients at an Academic Children’s Hospital
    Oxford University Press (OUP) ; 2019
    In:  Open Forum Infectious Diseases Vol. 6, No. Supplement_2 ( 2019-10-23), p. S639-S640
    Details
    In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 6, No. Supplement_2 ( 2019-10-23), p. S639-S640
    Abstract: Data on cytomegalovirus (CMV) infection and disease by donor (D)/recipient (R) status or prophylaxis regimen in pediatric hematopoietic cell transplant (HCT) recipients are limited. There is an absence of data on adverse events (AE) attributable to prophylaxis. Methods A single-center cohort (N = 352) of allogeneic HCT episodes between January 2004 and June 2017 was assembled. Exclusion criteria were CMV PCR positivity 30 days before HCT, lack of CMV surveillance ( 〈 2 blood PCRs in the 30 days post HCT), or unknown D/R CMV status. CMV prophylaxis was recommended for CMV D+ or R+ patients with ≥1 of the following factors: T-cell depletion, cord blood product, or exposure to distal alemtuzumab. The CMV prophylaxis regimen was standard-dose acyclovir from day −7 to +7, then foscarnet to engraftment, and then valganciclovir to day +100 (acyc → fos → valgan). If a patient did not meet criteria for CMV prophylaxis but was HSV IgG positive then standard-dose acyclovir was given from day −7 to the end of study follow-up (SD-acyc). All remaining patients did not receive antiviral prophylaxis. Outcomes of CMV infection and CMV disease by day +180 were captured. AEs attributable to antiviral prophylaxis were also identified. An AE was attributed to an antiviral prophylaxis medication if the dose was reduced or stopped. AEs were only reported in HCT episodes with complete medical records (n = 221). Results The CMV infection rate was 26.7%, with a median time to detection of 23.5 days (range: 4–146). CMV infection was common in D+/R+ (58.9%) and D−/R+ (34.6%) patients. Just under 11% of CMV infections progressed to disease (Figures 1 and 2). Breakthrough CMV infection occurred in 49.1% of patients despite acyc → fos → valgan (Figure 3) at a median of 11 days from HCT (range: 4–132). The attributable AE rate was 13.4% and 36.8% for SD-acyc and acyc → fos → valgan, respectively (Figure 4). Conclusion CMV infection was common in D+/R+ and D−/R+ patients, and a substantial proportion progressed to disease. Breakthrough infection persisted despite acyc → fos → valgan prophylaxis and AEs attributable to this regimen were common. CMV infection in R+ patients was frequent even in the absence of additional risk factors. Studies of novel prophylaxis approaches are needed and should include R+ patients regardless of other factors. Disclosures All authors: No reported disclosures.
    Type of Medium: Online Resource
    ISSN: 2328-8957
    URL: Article
    DOI: 10.1093/ofid/ofz360.1608
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2019
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  • 6
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    Outcomes of Human Adenovirus Infection and Disease in a Retrospective Cohort of Pediatric Hematopoietic Cell Transplant Recipients
    Oxford University Press (OUP) ; 2019
    In:  Journal of the Pediatric Infectious Diseases Society Vol. 8, No. 4 ( 2019-09-25), p. 317-324
    Details
    In: Journal of the Pediatric Infectious Diseases Society, Oxford University Press (OUP), Vol. 8, No. 4 ( 2019-09-25), p. 317-324
    Abstract: Human adenoviruses were commonly detected in this cohort of pediatric patients undergoing hematopoietic cell transplantation, and the case-fatality rate in allogeneic transplant recipients was high (25.9%). Preemptive cidofovir therapy was not associated with a reduction in the progression to human adenovirus disease.
    Type of Medium: Online Resource
    ISSN: 2048-7193 , 2048-7207
    URL: Article
    DOI: 10.1093/jpids/piy049
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2019
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  • 7
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    Prospective Evaluation of Galactomannan and (1→3) β- d -Glucan Assays as Diagnostic Tools for Invasive Fungal Disease in Children, Adolescents, and Young Adults With Acute Myeloid Leukemia Receiving Fungal Prophylaxis
    Oxford University Press (OUP) ; 2021
    In:  Journal of the Pediatric Infectious Diseases Society Vol. 10, No. 8 ( 2021-09-23), p. 864-871
    Details
    In: Journal of the Pediatric Infectious Diseases Society, Oxford University Press (OUP), Vol. 10, No. 8 ( 2021-09-23), p. 864-871
    Abstract: Patients receiving chemotherapy for acute myeloid leukemia (AML) are at high risk for invasive fungal disease (IFD). Diagnosis of IFD is challenging, leading to interest in fungal biomarkers. The objective was to define the utility of surveillance testing with Platelia Aspergillus galactomannan (GM) enzyme immunoassay (EIA) and Fungitell β-d-glucan (BDG) assay in children with AML receiving antifungal prophylaxis. Methods Twice-weekly surveillance blood testing with GM EIA and BDG assay was performed during periods of neutropenia in the context of a randomized trial of children, adolescents, and young adults with AML allocated to fluconazole or caspofungin prophylaxis. Proven or probable IFD was adjudicated using blinded central reviewers. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated for Platelia and Fungitell assays alone and in combination for the outcomes of proven and probable invasive aspergillosis (IA) or invasive candidiasis (IC). Results Among 471 patients enrolled, 425 participants (209 fluconazole and 216 caspofungin) contributed ≥1 blood specimen. In total, 6103 specimens were evaluated, with a median of 15 specimens per patient (range 1–43). The NPV was & gt;99% for GM EIA and BDG assay alone and in combination. However, there were no true positive results, resulting in sensitivity and PPV for each assay of 0%. Conclusions The GM EIA and the BDG assay alone or in combination were not successful at detecting IA or IC during periods of neutropenia in children, adolescents, and young adults with AML receiving antifungal prophylaxis. Utilization of these assays for surveillance in this clinical setting should be discouraged.
    Type of Medium: Online Resource
    ISSN: 2048-7207
    URL: Article
    DOI: 10.1093/jpids/piab036
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2021
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  • 8
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    1762. Genotype Prevalence and Molecular Characteristics of Human Adenovirus in Pediatric Hematopoietic Stem Cell Transplant Recipients
    Oxford University Press (OUP) ; 2019
    In:  Open Forum Infectious Diseases Vol. 6, No. Supplement_2 ( 2019-10-23), p. S648-S649
    Details
    In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 6, No. Supplement_2 ( 2019-10-23), p. S648-S649
    Abstract: Human adenovirus (HAdV) is a documented source of morbidity and mortality after hematopoietic cell transplant (HCT); however, there are limited data documenting HAdV species and type in this population. Understanding the molecular characteristics of HAdV could inform the development and assessment of interventions. The species and type of HAdV-positive specimens are detailed using an archived convenience sample of specimens obtained in pediatric HCT recipients. Methods The cohort included autologous and allogeneic HCT recipients between January 2000 and December 2013. An archived clinical repository of frozen specimens was interrogated to identify residual HAdV-positive specimens, which were sent to Lovelace Respiratory Research Institute (LRRI) to determine species and type. Medical chart review was performed to determine whether an isolate was related to HAdV disease or HAdV-attributable death. Results There were 547 HAdV PCR-positive clinical specimens from 87 HCT recipients. Of the 547 specimens, 289 were identified from an archived repository and sent to LRRI to determine species and type, and HAdV was successfully isolated and typed from 61 (Figure 1). Species C was the most common species (59.0%) with C2 being the most frequent type (34.4%). Of the 15 recipients with type C2, plasma was the most common specimen source (57.1%). Three recipients with C2 had this species and type detected from multiple sources (Tables 1 and 2). Among those with a typing result, type C2 also was responsible for 33.3% of all HAdV-attributed disease and 38.1% of all HAdV-attributed death. Conclusion Species C was the most common species to be isolated in a convenience sample of HAdV-positive clinical specimens from a single-center cohort of pediatric HCT recipients. Type C2 was most commonly associated with HAdV disease and attributable death. These results suggest HAdV species and type influence the impact of HAdV in this patient population. The findings need to be confirmed in prospective cohorts but suggest real-time molecular typing may be relevant and provide possible targets for the development of future interventions. These results must be interpreted with caution; not all clinical specimens were available for molecular typing, and it is possible C2 is easier to isolate from archived specimens. Disclosures All authors: No reported disclosures.
    Type of Medium: Online Resource
    ISSN: 2328-8957
    URL: Article
    DOI: 10.1093/ofid/ofz360.1625
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2019
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  • 9
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    688. Marginal Structure Models to Estimate the Effect of Cytomegalovirus Infection on Hospitalization Among Children Undergoing Allogeneic Hematopoietic Cell Transplantation
    Oxford University Press (OUP) ; 2020
    In:  Open Forum Infectious Diseases Vol. 7, No. Supplement_1 ( 2020-12-31), p. S397-S398
    Details
    In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 7, No. Supplement_1 ( 2020-12-31), p. S397-S398
    Abstract: Children receiving an allogeneic hematopoietic cell transplant (HCT) are at risk for cytomegalovirus (CMV) infection in the post-transplant period, necessitating routine surveillance for CMV. Some patients will not have CMV detected while others will have intermittent or persistent CMV detection. Prior analyses assessing the association of CMV infection on hospitalization in the post-transplant period have been limited by methods that did not consider the time-varying nature of the exposure (CMV reactivation) and its confounders or aim to obtain causal effect estimates. We aimed to assess the causal effect of CMV reactivation on hospitalization using a causal modeling approach. The Effect of CMV Infection on Hospitalization Using Generalized Estimating Equations and Marginal Structural Models Methods A cohort of allogeneic HCT patients transplanted at Children’s Hospital of Philadelphia January 2004–April 2017 was assembled and followed for 100 days after transplant. Eligible patients included those under CMV surveillance, defined as having ≥2 CMV whole blood polymerase chain reaction tests in the first month after HCT. All information was abstracted from medical charts. The association of CMV reactivation on the rate of hospitalization was estimated using traditional generalized estimating equations and repeated using a marginal structural model that accounted for time-varying exposure, confounders and non-random drop-out and obtained effects with causal interpretations. Results The study cohort included 340 pediatric allogeneic HCT recipients under CMV surveillance testing. 46.5% were female and the median age was 9 (range: 0 to 26). The CMV infection rate was 33.9%, with a median time to CMV detection of 23.5 days (range: 4-100). CMV infection was common in Donor+/Recipient+ (58.9%) and Donor-/Recipient+ (34.6%) patients. A traditional model estimates an additional week of CMV infection was associated with a 22% increase in average weekly hospitalization (Incidence rate ratio: 1.22, 95%: 1.12 -1.34). A marginal structure model estimates an additional week of CMV infection is associated with 3% increase in average weekly hospitalization incidence (Incidence rate ratio: 1.03, 95%: 0.91-1.16). Conclusion Our research showed the effect of CMV on hospitalization diminished after properly considering the time-varying nature of the CMV infection status and its confounders. Disclosures Brian T. Fisher, DO, MPH, MSCE, Astellas (Advisor or Review Panel member)Merck (Grant/Research Support)Pfizer (Grant/Research Support)
    Type of Medium: Online Resource
    ISSN: 2328-8957
    URL: Article
    DOI: 10.1093/ofid/ofaa439.880
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2020
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  • 10
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    1902. A Survey of Pediatric Bone Marrow Transplant Centers Regarding Local Cytomegalovirus Prophylaxis Management Practices and Interest in a Future Randomized Trial
    Oxford University Press (OUP) ; 2018
    In:  Open Forum Infectious Diseases Vol. 5, No. suppl_1 ( 2018-11-26), p. S546-S547
    Details
    In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 5, No. suppl_1 ( 2018-11-26), p. S546-S547
    Type of Medium: Online Resource
    ISSN: 2328-8957
    URL: Article
    DOI: 10.1093/ofid/ofy210.1558
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2018
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