Pyomyositis (PM) is an infrequent but increasing bacterial infection of the skeletal muscle, with muscles of the pelvis and thigh frequently involved. The diagnosis is often challenging, especially ...when a deep muscle is affected. We present a single-center pediatric cohort affected by pelvic PM. A retrospective analysis was performed, including children admitted to Meyer Children's Hospital between 2010 and 2020. Demographic, anamnestic, clinical, laboratory, radiological and management data were collected. Forty-seven patients (range 8 days-16.5 years, 66% males) were selected. Pain (64%), functional limitations (40%) and fever (38%) were the most common presenting symptoms; 11% developed sepsis. The median time to reach the diagnosis was 5 days (IQR 3-9). Staphylococcus aureus was the most common organism (30%), Methicillin-Resistant S aureus (MRSA) in 14%. PM was associated with osteomyelitis (17%), arthritis (19%) or both (45%). The infection was multifocal in 87% of children and determined abscesses in 44% (40% multiple). Pelvic MRI scan, including diffusion-weighted imaging (DWI), always showed abnormalities when performed. Clinical and laboratory findings in pelvic PM are unspecific, especially in infancy. Nevertheless, the infection may be severe, and the suspicion should be higher. MRI is the most useful radiological technique, and DWI sequence could reveal insidious infections.
Early start of highly active antiretroviral therapy (HAART) in perinatally HIV-1 infected children is the optimal strategy to prevent immunological and clinical deterioration. To date, according to ...EMA, only 35% of antiretroviral drugs are licenced in children < 2 years of age and 60% in those aged 2-12 years, due to the lack of adequate paediatric clinical studies on pharmacokinetics, pharmacodynamics and drug safety in children.
An observational retrospective study investigating the rate and the outcomes of off-label prescription of HAART was conducted on 225 perinatally HIV-1 infected children enrolled in the Italian Register for HIV Infection in Children and followed-up from 2001 to 2018.
22.2% (50/225) of included children were receiving an off-label HAART regimen at last check. Only 26% (13/50) of off-label children had an undetectable viral load (VL) before the commencing of the regimen and the 52.0% (26/50) had a CD4 + T lymphocyte percentage > 25%. At last check, during the off label regimen, the 80% (40/50) of patients had an undetectable VL, and 90% (45/50) of them displayed CD4 + T lymphocyte percentage > 25%. The most widely used off-label drugs were: dolutegravir/abacavir/lamivudine (16%; 8/50), emtricitbine/tenofovir disoproxil (22%; 11/50), lopinavir/ritonavir (20%; 10/50) and elvitegravir/cobicistat/emtricitabine/ tenofovir alafenamide (10%; 10/50). At logistic regression analysis, detectable VL before starting the current HAART regimen was a risk factor for receiving an off-label therapy (OR: 2.41; 95% CI 1.13-5.19; p = 0.024). Moreover, children < 2 years of age were at increased risk for receiving off-label HAART with respect to older children (OR: 3.24; 95% CI 1063-7.3; p = 0.001). Even if our safety data regarding off-label regimens where poor, no adverse event was reported.
The prescription of an off-label HAART regimen in perinatally HIV-1 infected children was common, in particular in children with detectable VL despite previous HAART and in younger children, especially those receiving their first regimen. Our data suggest similar proportions of virological and immunological successes at last check among children receiving off-label or on-label HAART. Larger studies are needed to better clarify efficacy and safety of off-label HAART regimens in children, in order to allow the enlargement of on-label prescription in children.
COVID-19 is generally milder in children than in adults, however severe infection has been described in some patients. Few data are available on use of Remdesivir (RDV) in children, as most clinical ...trials focused on adult patients. We report a multicenter study conducted in 10 Italian Hospitals to investigate the safety of RDV in children affected by COVID-19.
We collected the clinical data of children with COVID-19 treated with RDV between March 2020 and February 2022 in 10 Italian hospitals. Clinical data were compared according to a duration of RDV therapy more or less than 5 days. Linear regression model was used to determine the association of significant variables from the bivariate analysis to the duration of RDV therapy.
A total of 50 patients were included, with a median age of 12.8 years. Many patients had at least one comorbidity (78%), mostly obesity. Symptoms were fever (88%), cough (74%) and dyspnea (68%). Most patients were diagnosed with pneumonia of either viral and/or bacterial etiology. Blood test showed leukopenia in 66% and increased C-reactive protein (CRP) levels in 63% of cases. Thirty-six patients received RDV for 5 days, nine patients up to 10 days. Most children who received RDV longer were admitted to the PICU (67%). Treatment with RDV was well tolerated with rare side effects: bradycardia was recorded in 6% of cases, solved in less than 24 h after discontinuation. A mild elevation of transaminases was observed in 26% of cases, however for the 8%, it was still detected before the RDV administration. Therefore, in these cases, we could not establish if it was caused by COVID-19, RDV o both. Patients who received RDV for more than 5 days waited longer for its administration after pneumonia diagnosis. The presence of comorbidities and the duration of O2 administration significantly correlated with the duration of RDV therapy at the linear regression analysis.
Our experience indicates that RDV against SARS-CoV-2 is safe and well-tolerated in pediatric populations at high risk of developing severe COVID-19. Our data suggest that delaying RDV therapy after diagnosis of pneumonia may be associated with a longer duration of antiviral therapy, especially in patients with comorbidities.
US Food and Drug Administration has issued Emergency Use Authorizations for hundreds of serological assays to support Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) diagnosis. The aim ...of this study is to evaluate, for the first time in children, the performance of three widely utilized SARS-CoV-2 serology commercial assays, Diesse Diagnostics (IgG, IgA, IgM) and Roche Diagnostics, both Roche Nucleocapsid (N) IgG and Roche Spike (S) IgG assays.
Sensitivity and 95% confidence intervals (CIs) were estimated for each of the three different serological tests and mixed and direct comparison were performed. Univariate and multivariate Poisson regression models were fitted to calculate incidence rate ratios and 95% CIs as estimate of the effects of age, gender, time on the serology title. A p-value < 0.05 indicated statistical significance.
Overall, 149 children were enrolled in the study. A low sensitivity was found for Diesse IgA, IgM and IgG. Compare to Diesse, Roche S had a higher sensitivity at 15-28 days from infection (0.94, 95%CI: 0.73-1.0) and Roche N at 28-84 days (0.78, 95%CI: 0.58-0.91). When a direct comparison of IgG tests sensitivity was feasible for patients with pairwise information, Roche S and Roche N showed a statistically significant higher sensitivity compared to Diesse in all the study periods, whereas there was no difference between the two Roche tests.
Roche S and Roche N serology tests seem to better perform in children. Large prospective studies are needed to better define the characteristics of those tests.
Point prevalence surveys have been used in several studies to provide immediate and easily comparable information about antibiotic use and showed that about one third of hospitalised children had on ...ongoing antimicrobial prescription during their hospital admission. The aim of this study, as part of the Global Antimicrobial Resistance, Prescribing and Efficacy in Neonates and Children project, is to describe antimicrobial prescriptions among hospitalised children in four tertiary care hospitals in Italy to show if something has changed over the years.
Four tertiary care Italian's hospitals joined three Point Prevalence Surveys (PPSs) in three different period of the year. All children under 18 years of age with an ongoing antimicrobial prescription, admitted on the participating wards at 8 o'clock in the morning of the selecting day were enrolled.
A total of 1412 patients (475 neonates and 937 children) were admitted in the days of three PPSs. Overall, among the total admitted patients, 565 patients (40%) had an ongoing antimicrobial prescription in the days of the survey A total of 718 antibiotics were administered in the 485 admitted children and 133 in neonates. The most common indications for antibiotic therapy in children was Lower respiratory tract infections (244/718, 34%), while in neonates were prophylaxis for medical problems (35/133, 26.3%), newborn prophylaxis for newborn risk factors (29/133, 21.8%) and prophylaxis for surgical disease (15/133, 11.3%).
Based on our results, it appears that nothing has changed since the last PPS and that the quality improved targets, underlyined in previous studies, are always the same. Serial PPSs can be part of AMS strategies but they are not sufficient alone to produce changes in clinical practice.
The fast diffusion of the SARS-CoV-2 pandemic have called for an equally rapid evolution of the therapeutic options.The Human recombinant monoclonal antibodies (mAbs) have recently been approved by ...the Food and Drug Administration (FDA) and by the Italian Medicines Agency (AIFA) in subjects aged ≥12 with SARS-CoV-2 infection and specific risk factors.Currently the indications are specific for the use of two different mAbs combination: Bamlanivimab+Etesevimab (produced by Eli Lilly) and Casirivimab+Imdevimab (produced by Regeneron).These drugs have shown favorable effects in adult patients in the initial phase of infection, whereas to date few data are available on their use in children.AIFA criteria derived from the existing literature which reports an increased risk of severe COVID-19 in children with comorbidities. However, the studies analyzing the determinants for progression to severe disease are mainly monocentric, with limited numbers and reporting mostly generic risk categories.Thus, the Italian Society of Pediatrics invited its affiliated Scientific Societies to produce a Consensus document based on the revision of the criteria proposed by AIFA in light of the most recent literature and experts' agreement.This Consensus tries to detail which patients actually have the risk to develop severe disease, analyzing the most common comorbidities in children, in order to detail the indications for mAbs administration and to guide the clinicians in identifying eligible patients.
Abstract Background Interferon-γ release assays (IGRAs), including the commercially available T-SPOT.TB, QuantiFERON-TB Gold (QFT-G), and QuantiFERON-TB Gold In-Tube (QTF-G-IT), enable detection of ...circulating T lymphocytes responsive to specific Mycobacterium tuberculosis antigens. Studies of the potential role of serial IGRAs for assessment of response to anti-tubercular therapy are accumulating. Objective The objective of this systematic review was to evaluate the potential clinical utility of serial IGRAs in anti-tubercular therapy. Methods We conducted a literature search of the Cochrane Library and MEDLINE by PubMed, from database inception through October 1, 2011, for serial IGRA results in anti-tubercular therapy, in adults and children, using commercial stardardized assays. All types of articles in the English language were included. Meta-analysis was performed to estimate the pooled percentage of reversion from a positive to a negative IGRA value at 3- to 6-month follow-up. Results According to inclusion and exclusion criteria, three T-SPOT.TB–based ( n = 319 patients), three QFT-G–based (n = 75 patients), and seven QFT-G-IT-based (n = 558 patients) longitudinal studies were included. The percentage of patients with reversion from a positive to a negative IGRA value ranged from 5.71% to 13.93% for T-SPOT.TB, 5.26% to 71.05% for QFT-G, and 14.28% to 41.89% for QFT-G-IT assays. Meta-analysis estimation of reversion was feasible only for the QFT-G-IT assay, at 30.54% (95% CI, 22.89–38.75). In two pediatric studies, which were QFT-G-IT based (n = 122 children), the reported reversion rates were 14.28% and 20.33%, respectively. Conclusions Because IGRAs require time and cost resources, and reversion from positive to negative IGRA values occurs in a minority of treated patients, monitoring IGRA changes over time seems to have only speculative value in adults. Data in children are poor, but are in line with results reported in adults.
Control of vaccine preventable diseases (VPDs) is a challenge for healthcare systems. Different studies highlighted the suboptimal immunization of internationally adopted children (IAC). To evaluate ...the immunization status against measles, mumps, rubella (MMR), and varicella (V) in a large cohort of IAC, data at first screening visit of all IAC (<18 years) consecutively referred to Meyer Children's University Hospital (Florence, Italy) from 2009 to 2018 were collected and analyzed. In total, 1927 children (median age: 5.99 years, interquartile range: 3.33-8.21) were enrolled. More than half of IAC were unprotected against MMR-V. The reliability of the vaccination documentation of the country of origin was poor, since more than a quarter of the IAC serologically tested were not protected against MMR-V, despite the vaccination documentation attesting previous vaccination. This was significantly more pronounced in children aged 15-18 years and in those originating from Africa. High rate of discordant serological results/documentation brings up questions regarding the optimal management of IACs, and suggests a rapid, careful, and complete assessment of immunization status timely after IAC's arrival. Serological testing of IAC of all ages followed by vaccination of seronegative children should be provided.
Linezolid is a new drug from the oxazolidinone class of antibiotics used against mycobacteria and multi-drug resistant (MDR) Gram-positive bacterial infections, which may are also ...glycopeptide-resistant. The drug usage in pediatric age needs an accurate drug monitoring for effective patient management. The aim of this study was to evaluate the use of dried blood spot (DBS) specimens to determinate linezolid levels during treatment. Advantages of DBS include short collection time, low invasiveness, ease and low cost of sample collection, transport and storage. The analysis was performed in LC–MS/MS operating in positive ion mode and multiple reaction monitoring (MRM) mode. The calibration curve in matrix was linear in the concentration range of 1–100mg/L with correlation coefficient value of 0.9987. Intraday and interday coefficients of variation were within 3.6% and 13.0%, respectively. We also tested the thermal and temporal drug stability in dried blood spots at four different temperatures to evaluate the risks of sample delivery in different conditions. The short term stability studies showed that linezolid concentration remained stable for at least one month under all the conditions tested.
This new assay has favorable characteristics being highly precise and accurate and allows a fast linezolid analysis with a total run time 22min long, in gradient analysis. Concentration data for plasma and DBS samples from patients after treatment were compared showing a good correlation.
Correlation between DBS data and serum samples measured by HPLC–UV was satisfactory.
The benefit for patients is the ability to monitor the treatment with a simple and convenient sample collection at home.
Internationally Adopted Children (IAC) often show suboptimal immunisation coverage, but available data are discordant. Data at the first evaluation of 2073 IAC (median age: 6 years) referred to the ...Meyer Children’s University Hospital (Florence, Italy) in 2009–2019 were analysed in order to evaluate their immunisation status against diphtheria, tetanus, and hepatitis B. Negative antibody titres were observed in 11.5% of the IAC for diphtheria, 18.6% for tetanus, and 39.0% for hepatitis B. At multivariate analysis, originating from Africa was an independent risk factor for seronegativity for the three diseases (p < 0.001), while age below four years was an independent factor associated with protective immunity, only considering hepatitis B (p < 0.001). Vaccine documentation was an additional factor independently associated with protective immunity. However, a discrepancy between documentation (indicating previous vaccinations) and serology (showing negative antibody titres) was evidenced in 3.8% of the children for diphtheria, 12.6% for tetanus, and 29.6% for hepatitis B. This finding suggests that although vaccine documentation may reflect the presence of protective antibody titres, it should not be accepted as absolute evidence of protective immunity, underlining the importance of a complete assessment of immunisation status in IAC, particularly in those originating from Africa and aged over four years.
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