American College of Rheumatology Provisional Criteria for Clinically Relevant Improvement in Children and Adolescents With Childhood-Onset Systemic Lupus Erythematosus

10.1002/acr.23834ARTHRITIS CARE & RESEARCH715579-59

Paediatric emergency departments should manage young febrile and afebrile infants the same if they have a fever before presenting

AIM: Our aim was to evaluate the risk of bacterial meningitis, bacteremia, and urinary tract infection (UTI) in infants ≤60 days who presented to pediatric emergency departments (PEDs) after having fever at home. We also investigated any differences between infants who were afebrile or febrile on presentation.METHODS: Multicenter retrospective study of infants ≤60 days presented to 4 Swedish PEDs during 2014-2020 with reported fever at home. We used relative risks (RR) to compare the prevalence of UTI, bacteremia, and bacterial meningitis between the infants who were afebrile and the infants who were still febrile when they presented to the PED.RESULTS: The cohort comprised 1926 infants and 702 (36%) were afebrile on presentation. The prevalence of UTI in the afebrile and febrile infants were 6.1% (95% CI 4.5-8.2) versus 14.2% (95% CI 12.3-16.2), corresponding to an RR of 0.43 (95% CI 0.31-0.59). In infants ≤28 days the RR for meningitis was 1.05 (95% CI 0.18-6.23) for afebrile versus febrile infants. Five times more febrile infants underwent a lumbar puncture.CONCLUSION: Infants who were afebrile on presentation underwent fewer lumbar punctures, but they had similar rates of bacterial meningitis to febrile infants. Different management approaches are not justified

Utilidad de las pruebas básicas de estudio de la función renal en la toma de decisiones en niños con pérdida de parénquima renal o dilatación de la vía urinaria

ResumenLas pruebas básicas de estudio de la función renal como la osmolalidad urinaria máxima y la eliminación urinaria de albúmina y de N-acetil-glucosaminidasa se alteran con mucha frecuencia en situaciones clínicas que cursan con hiperpresión en la vía urinaria o con pérdida de parénquima renal. No obstante, en todos los algoritmos que se pueden consultar dedicados al estudio de los niños con infección urinaria o dilatación de la vía urinaria nunca se menciona el beneficio del uso de esos parámetros funcionales. En esta revisión, ofrecemos información acerca de la utilidad práctica que conlleva la determinación de los parámetros básicos de estudio de la función renal. A partir de esos datos proponemos un algoritmo destinado a realizar una petición razonada de la cistografía conjuntando parámetros morfológicos y funcionales.AbstractBasic renal function tests such as maximum urine osmolality and urinary elimination of albumin and N-acetyl-glucosaminidase often reveal abnormalities in clinical cases involving hyperpressure in the urinary tract or loss of renal parenchyma. However, in all the available algorithms dedicated to the study of children with urinary tract infection or dilation, the benefit of using these functional parameters is not mentioned. In this review, we provide information about the practical usefulness of assessing the basic renal function parameters. From these data, we propose an algorithm that combines morphological and functional parameters to make a reasoned case for voiding cystourethrography

Management and Outcome of Febrile Infants ≤60 days, With Emphasis on Infants ≤21 Days Old, in Swedish Pediatric Emergency Departments

BACKGROUND: Management of febrile infants ≤60 days of age varies, and the age for routine investigations and antibiotic-treatment is debated. The American Academy of Pediatrics recommended age threshold for lumbar puncture (LP) is 21 days and for blood culture 60 days. We describe management and adverse outcome of febrile infants ≤60 days old, in Sweden.METHODS: Retrospective cross-sectional study of infants ≤60 days of age with fever without source evaluated in 4 University pediatric emergency departments, between 2014 and 2017. Adverse outcome was defined as delayed-treated invasive bacterial infection (IBI: meningitis or bacteremia).RESULTS: We included 1701 infants. In infants ≤21 days old, LP was performed in 16% (95% CI: 12-20) and blood culture in 43% (95% CI: 38-48). Meningitis was diagnosed in 5 (1.3%; 95% CI: 0.4-3.0) and bacteremia in 12 (4.5%; 95% CI: 2.6-7.0) infants. Broad-spectrum antibiotics were not administered to 66% (95% CI: 61-71), of which 2 (0.8%; 95% CI: 0.1-2.8) diagnosed with IBI (1 meningitis and 1 bacteremia). In the 29-60 days age group, blood culture was performed in 21% (95% CI: 19-24), and broad-spectrum antibiotics were not administered to 84% (95% CI: 82-86), with no case of delayed-treated bacteremia.CONCLUSIONS: The rates of LP, blood culture and broad-spectrum antibiotics were low. Despite that, there were few delayed-treated IBIs, but 2 of the 17 infants ≤21 days of age with IBI were not timely treated, which prompts the need for a safer approach for this age group. Also, the utility of routine blood culture for all febrile infants 29-60 days old could be questioned

Age- and sex-specific prevalence of serious bacterial infections in febrile infants ≤60 days, in Sweden

Aim: The aim of the study was to describe age- and sex-specific prevalence of serious bacterial infections (SBI: urinary tract infection, bacteraemia, meningitis) among febrile infants ≤60 days in Sweden. Methods: This is a retrospective study in 4 Pediatric Emergency Departments from 2014 to 2017, in previously healthy, full-term infants ≤60 days with fever without a source. Results: Of the 1,701 included infants, 214 (12.6%; 95% CI, 11.1–14.3) had an SBI. Urinary tract infection (UTI) was diagnosed in 196 (11.5%; 95% CI, 10.0–13.1) patients. In the ≤28 and 29–60 days age-groups, meningitis prevalence was 0.9% (95% CI, 0.3–2.0) and 0.3% (95% CI, 0.1–0.8), whereas bacteraemia prevalence was 3.2% (95% CI, 1.9–4.9) and 0.6% (95% CI, 0.2–1.3). The SBI prevalence was higher in boys 16.0% (95% CI, 13.8–18.5) than girls 8.0% (95% CI, 6.2–10.2; p<0.001), due to 2-fold higher UTI risk. The prevalence of meningitis in boys was 0.3% (95% CI, 0.1– 0.9) vs. 0.7% (95% CI, 0.2–1.6) in girls and of bacteraemia 1.8% (95% CI, 1.0–2.8) vs. 1.0% (95% CI, 0.4–2.0), respectively. Conclusions: The total SBI prevalence was 12.6%, and UTI represented the vast majority. The prevalence of bacteraemia and meningitis was low, particularly in the 29–60 days age group, without significant difference between boys and girls

American college of rheumatology provisional criteria for clinically relevant improvement in children and adolescents with childhood-onset systemic Lupus erythematosus

To develop a Childhood Lupus Improvement Index (CHILI) as a tool to measure response to therapy in childhood-onset systemic lupus erythematosus (cSLE), with a focus on clinically relevant improvement (CRIcSLE). Methods Pediatric nephrology and rheumatology subspecialists (n = 213) experienced in cSLE management were invited to define CRIcSLE and rate a total of 433 unique patient profiles for the presence/absence of CRIcSLE. Patient profiles included the following cSLE core response variables (CRVs): global assessment of patient well-being (patient-global), physician assessment of cSLE activity (MD-global), disease activity index score (here, we used the Systemic Lupus Erythematosus Disease Activity Index), urine protein-to-creatinine ratio, and Child Health Questionnaire physical summary score. Percentage and absolute changes in these cSLE-CRVs (baseline versus follow-up) were considered in order to develop candidate algorithms and validate their performance (sensitivity, specificity, area under the receiver operating characteristic curve [AUC]; range 0-1). Results During an international consensus conference, unanimous agreement on a definition of CRIcSLE was achieved; cSLE experts (n = 13) concurred (100%) that the preferred CHILI algorithm considers absolute changes in the cSLE-CRVs. After transformation to a range of 0-100, a CHILI score of >= 54 had outstanding accuracy for identifying CRIcSLE (AUC 0.93, sensitivity 81.1%, and specificity 84.2%). CHILI scores also reflect minor, moderate, and major improvement for values exceeding 15, 68, and 92, respectively (all AUC >= 0.92, sensitivity >= 93.1%, and specificity >= 73.4%). Conclusion The CHILI is a new, seemingly highly accurate index for measuring CRI in cSLE over time. This index is useful to categorize the degree of response to therapy in children and adolescents with cSLE.715579590CNPQ - Conselho Nacional de Desenvolvimento Científico e TecnológicoFAPESP – Fundação de Amparo à Pesquisa Do Estado De São Paulo303422/2015-7; 7/2016-9; 304255/2015-7215/03756-

Subcutaneous anti-COVID-19 hyperimmune immunoglobulin for prevention of disease in asymptomatic individuals with SARS-CoV-2 infection: a double-blind, placebo-controlled, randomised clinical trialResearch in context

Summary: Background: Anti-COVID-19 hyperimmune immunoglobulin (hIG) can provide standardized and controlled antibody content. Data from controlled clinical trials using hIG for the prevention or treatment of COVID-19 outpatients have not been reported. We assessed the safety and efficacy of subcutaneous anti-COVID-19 hyperimmune immunoglobulin 20% (C19-IG20%) compared to placebo in preventing development of symptomatic COVID-19 in asymptomatic individuals with SARS-CoV-2 infection. Methods: We did a multicentre, randomized, double-blind, placebo-controlled trial, in asymptomatic unvaccinated adults (≥18 years of age) with confirmed SARS-CoV-2 infection within 5 days between April 28 and December 27, 2021. Participants were randomly assigned (1:1:1) to receive a blinded subcutaneous infusion of 10 mL with 1 g or 2 g of C19-IG20%, or an equivalent volume of saline as placebo. The primary endpoint was the proportion of participants who remained asymptomatic through day 14 after infusion. Secondary endpoints included the proportion of individuals who required oxygen supplementation, any medically attended visit, hospitalisation, or ICU, and viral load reduction and viral clearance in nasopharyngeal swabs. Safety was assessed as the proportion of patients with adverse events. The trial was terminated early due to a lack of potential benefit in the target population in a planned interim analysis conducted in December 2021. ClinicalTrials.gov registry: NCT04847141. Findings: 461 individuals (mean age 39.6 years [SD 12.8]) were randomized and received the intervention within a mean of 3.1 (SD 1.27) days from a positive SARS-CoV-2 test. In the prespecified modified intention-to-treat analysis that included only participants who received a subcutaneous infusion, the primary outcome occurred in 59.9% (91/152) of participants receiving 1 g C19-IG20%, 64.7% (99/153) receiving 2 g, and 63.5% (99/156) receiving placebo (difference in proportions 1 g C19-IG20% vs. placebo, −3.6%; 95% CI -14.6% to 7.3%, p = 0.53; 2 g C19-IG20% vs placebo, 1.1%; −9.6% to 11.9%, p = 0.85). None of the secondary clinical efficacy endpoints or virological endpoints were significantly different between study groups. Adverse event rate was similar between groups, and no severe or life-threatening adverse events related to investigational product infusion were reported. Interpretation: Our findings suggested that administration of subcutaneous human hyperimmune immunoglobulin C19-IG20% to asymptomatic individuals with SARS-CoV-2 infection was safe but did not prevent development of symptomatic COVID-19. Funding: Grifols