John Bradley, Emmanuel Roilides, Margaret Tawadrous, Jean Li Yan, Elena Soto, Gregory G Stone, Shweta Kamat, Paurus Irani, Richard England
{"title":"Pharmacokinetics and Safety of Ceftazidime-Avibactam in Neonates and Young Infants: A Phase 2a, Multicenter Prospective Trial.","authors":"John Bradley, Emmanuel Roilides, Margaret Tawadrous, Jean Li Yan, Elena Soto, Gregory G Stone, Shweta Kamat, Paurus Irani, Richard England","doi":"10.1093/jpids/piaf028","DOIUrl":"10.1093/jpids/piaf028","url":null,"abstract":"<p><strong>Background: </strong>This phase 2a study evaluated pharmacokinetics and safety of ceftazidime-avibactam (CAZ/AVI; combination dosed as fixed 4:1 ratio) in neonates and young infants with suspected/confirmed infections due to Gram-negative pathogens requiring intravenous antibiotics.</p><p><strong>Methods: </strong>Hospitalized neonates and infants (gestational age ≥ 26 weeks to < 3 months), enrolled sequentially into 3 age cohorts, received CAZ/AVI single dose (Part A) or multiple dose every 8 h (Part B) by 2-h intravenous infusions. Infants > 28 days (Cohort 1) received CAZ/AVI 37.5 mg/kg/dose (CAZ 30 mg/kg and AVI 7.5 mg/kg). Full-term neonates ≤ 28 days (Cohort 2) and preterm neonates ≤ 28 days (Cohort 3) received 25 mg/kg/dose (CAZ 20 mg/kg and AVI 5 mg/kg). Pharmacokinetics, safety, and clinical and microbiological outcomes (Part B only) were assessed descriptively.</p><p><strong>Results: </strong>Forty-six patients received CAZ/AVI, 25 in Part A and 21 in Part B. Sepsis (39.1%) and urinary tract infection (15.2%) were the predominant diagnoses. Observed drug plasma-concentration time profiles were generally similar across cohorts. Overall, 23 patients (50%) had ≥ 1 adverse event (AE), 8 patients (17.4%) had ≥ 1 serious AE (SAE), and 2 patients (4.3%) died; no SAE or death was treatment related. In Part B, ≥ 80% of patients had favorable clinical and microbiological responses.</p><p><strong>Conclusions: </strong>Plasma exposures after single and multiple CAZ/AVI doses in neonates and young infants < 3 months old (37.5 [30/7.5] mg/kg/dose for > 28 days; 25 [20/5] mg/kg/dose for ≤ 28 days) were similar to approved doses for older children. The safety profile of CAZ/AVI was as expected based on previous observations. Study funded by Pfizer. Trial registration: NCT04126031.</p>","PeriodicalId":17374,"journal":{"name":"Journal of the Pediatric Infectious Diseases Society","volume":" ","pages":""},"PeriodicalIF":2.5,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12117184/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143979148","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Kareena Kloek, Ritu Banerjee, Meng Xu, Sophie E Katz
{"title":"Patient Demographics Are Associated With Testing for Group A Streptococcal Pharyngitis in Children.","authors":"Kareena Kloek, Ritu Banerjee, Meng Xu, Sophie E Katz","doi":"10.1093/jpids/piaf029","DOIUrl":"10.1093/jpids/piaf029","url":null,"abstract":"<p><p>Among a retrospective cohort of 65 786 outpatient encounters for children >3 years with acute respiratory tract infection at an academic institution in 2023, 38 790 (59%) had a rapid group A streptococcal (GAS) test ordered. Testing rates differed significantly by race, ethnicity, insurance type, social vulnerability index, visit location, and clinician type, and children in historically underserved and socially vulnerable groups were less likely to undergo GAS testing compared to their social counterparts.</p>","PeriodicalId":17374,"journal":{"name":"Journal of the Pediatric Infectious Diseases Society","volume":" ","pages":""},"PeriodicalIF":2.5,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12084825/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143978887","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Celisse Zabalo, Athanasios Tsalatsanis, Ambuj Kumar, Claudia Espinosa, Amol Purandare, Carina A Rodriguez, Christina Olson, Claudia Gaviria-Agudelo
{"title":"Pediatric Infectious Disease Outpatient Telehealth: An Accepted Model of Care.","authors":"Celisse Zabalo, Athanasios Tsalatsanis, Ambuj Kumar, Claudia Espinosa, Amol Purandare, Carina A Rodriguez, Christina Olson, Claudia Gaviria-Agudelo","doi":"10.1093/jpids/piaf012","DOIUrl":"10.1093/jpids/piaf012","url":null,"abstract":"<p><p>This retrospective cohort study assessed the differences between in-person vs telehealth (TH) services in pediatric infectious diseases. TH was noted to be used more frequently by Hispanic patients and established patients. TH decreased travel distance and no-show/cancellation rates. TH offers a valuable outpatient option for pediatric infectious disease patients.</p>","PeriodicalId":17374,"journal":{"name":"Journal of the Pediatric Infectious Diseases Society","volume":" ","pages":""},"PeriodicalIF":2.5,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143391148","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Caitlin Naureckas Li, Taylor Heald-Sargent, Kathleen Murtagh, Erin Claussen, Ravi Jhaveri
{"title":"Billing for and Documentation of Provider-to-Provider Interprofessional Consults in Infectious Diseases.","authors":"Caitlin Naureckas Li, Taylor Heald-Sargent, Kathleen Murtagh, Erin Claussen, Ravi Jhaveri","doi":"10.1093/jpids/piaf033","DOIUrl":"10.1093/jpids/piaf033","url":null,"abstract":"<p><p>Infectious diseases providers are frequently asked to provide \"curbside\" advice for patients they have not seen. We describe our experience in implementing a process for documentation of and billing for these provider-to-provider consultations.</p>","PeriodicalId":17374,"journal":{"name":"Journal of the Pediatric Infectious Diseases Society","volume":" ","pages":""},"PeriodicalIF":2.5,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144023904","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Survey response rates: Reassessing expectations.","authors":"Marie E Heffernan, Michelle L Macy","doi":"10.1093/jpids/piaf031","DOIUrl":"10.1093/jpids/piaf031","url":null,"abstract":"","PeriodicalId":17374,"journal":{"name":"Journal of the Pediatric Infectious Diseases Society","volume":" ","pages":""},"PeriodicalIF":2.5,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143989291","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jennifer Moore, Daren Austin, Alicia Aylott, Jerzy Daniluk, Leah A Gaffney, Marjan Hezareh, Ahmed Nader, Nadia Noormohamed, Charlene Parado, Amanda Peppercorn, Yessica Sachdeva, Scott Segal, Klaudia Steplewski, Phillip J Yates, Jill Walker, Andrew Skingsley
{"title":"Pharmacokinetics and Safety of Single-Dose Sotrovimab in High-Risk Children and Adolescents With Mild-to-Moderate COVID-19.","authors":"Jennifer Moore, Daren Austin, Alicia Aylott, Jerzy Daniluk, Leah A Gaffney, Marjan Hezareh, Ahmed Nader, Nadia Noormohamed, Charlene Parado, Amanda Peppercorn, Yessica Sachdeva, Scott Segal, Klaudia Steplewski, Phillip J Yates, Jill Walker, Andrew Skingsley","doi":"10.1093/jpids/piaf027","DOIUrl":"10.1093/jpids/piaf027","url":null,"abstract":"","PeriodicalId":17374,"journal":{"name":"Journal of the Pediatric Infectious Diseases Society","volume":" ","pages":""},"PeriodicalIF":2.5,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12084821/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143729955","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Cytomegalovirus Saliva Shedding Kinetics in Children with Congenital CMV Infection.","authors":"Swetha Pinninti, Sunil Pati, Zdenek Novak, Karen Fowler, Suresh Boppana, Shannon Ross","doi":"10.1093/jpids/piaf040","DOIUrl":"10.1093/jpids/piaf040","url":null,"abstract":"<p><strong>Background: </strong>Congenital CMV (cCMV) is a common congenital viral infection worldwide and the most common cause of childhood non-genetic sensorineural hearing loss (SNHL). The kinetics of CMV detection (shedding) from mucosal surfaces have not been extensively described in children with cCMV due to a lack of systematic newborn CMV screening and follow-up protocols. The aim of this study is to describe the natural history of saliva CMV shedding in a cCMV cohort, which was identified through universal newborn screening.</p><p><strong>Methods: </strong>As part of the CMV and Hearing Multicenter Screening study (CHIMES), 100 332 newborns were screened, and those confirmed to have cCMV were followed prospectively every six months for four years to determine hearing outcomes. Saliva CMV DNA shedding kinetics, including duration, viral load (VL), and intermittent shedding are described and compared between groups with and without newborn symptoms and hearing loss in children with ≥5 visits.</p><p><strong>Results: </strong>The 197 children with confirmed cCMV shed CMV DNA in saliva for a median of 20 months with CMV shedding frequency decreasing from 100% at cCMV confirmation to 9.5% four years after enrollment. Similarly, median CMV DNA VL levels decreased from 8.89 × 106 IU/mL at the confirmation visit to 1.64 × 103 IU/mL at the 4-year follow-up visit. Saliva CMV shedding duration was similar between children with or without newborn symptoms (median 20 months for both groups; P = .57) or between those with SNHL vs normal hearing (P = .8). A third of the cohort intermittently shed CMV DNA in saliva (64/197, 32.5%).</p><p><strong>Conclusions: </strong>In this large cohort of children with cCMV identified by universal CMV newborn screening, CMV DNA was detectable in saliva for a median of 20 months, irrespective of newborn symptoms or hearing outcomes. Intermittent shedding was noted in a third of the cohort.</p>","PeriodicalId":17374,"journal":{"name":"Journal of the Pediatric Infectious Diseases Society","volume":" ","pages":""},"PeriodicalIF":2.5,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143978885","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Population Pharmacokinetic Analysis and Pharmacodynamic Evaluation of Sulbactam in Pediatric Patients: Dosing Suggestions for Acinetobacter baumannii Infections.","authors":"Tetsushu Onita, Yui Sano, Kazuro Ikawa, Noriyuki Ishihara, Hiroki Tamaki, Takahisa Yano","doi":"10.1093/jpids/piaf043","DOIUrl":"10.1093/jpids/piaf043","url":null,"abstract":"<p><strong>Background: </strong>This study aims to develop a population pharmacokinetic (PK) model of sulbactam in pediatric patients using pooled data analysis, and to optimize dosing regimens against Acinetobacter baumannii infections.</p><p><strong>Methods: </strong>Publications were systematically identified with MEDLINE for collecting sulbactam PK data in pediatric patients. Sulbactam PK model was developed using plasma concentration-time data gained from identified literature works. Based on the model, we estimated the probability of attaining the pharmacodynamic (PD) target against A. baumannii.</p><p><strong>Results: </strong>The data were adequately described by 2-compartment model. Age was a statistically significant covariate in clearance. Aiming for the PD target of 60% of time above minimum inhibitory concentration in free drug concentrations (fT > MIC), the breakpoint MICs were increased by extending infusion time from 0.5 to 4 hours. The breakpoint MICs for 4-hour infusion regimens of 25 mg/kg 4 times daily (100 mg/kg/day) achieved 4 μg/mL in infants (4 weeks to 11 months), children (1-6 years old) and pediatrics (7-16 years old). The breakpoint values for 4-hour infusions of 50 mg/kg 4 times daily (200 mg/kg/day) achieved 8 μg/mL (intermediate range of Clinical and Laboratory Standards Institute criteria) in all age groups.</p><p><strong>Conclusions: </strong>This population PK analysis and PD evaluation suggest that higher dosing regimen, especially with extended infusion time, should be reasonable for treating A. baumannii infections in pediatric patients.</p>","PeriodicalId":17374,"journal":{"name":"Journal of the Pediatric Infectious Diseases Society","volume":" ","pages":""},"PeriodicalIF":2.5,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12123189/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144111299","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Survey of Pediatric Infectious Diseases Providers on Healthcare Sustainability and Climate Change.","authors":"Shreya M Doshi, Allyson Dalby, Preeti Jaggi","doi":"10.1093/jpids/piaf038","DOIUrl":"https://doi.org/10.1093/jpids/piaf038","url":null,"abstract":"","PeriodicalId":17374,"journal":{"name":"Journal of the Pediatric Infectious Diseases Society","volume":"14 5","pages":""},"PeriodicalIF":2.5,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144159886","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Brittney Sweetser, Esin Nkereuwem, Jascent Nakafeero, Marie Gomez, Peter Wambi, Moses Nsereko, Alfred Andama, Joel D Ernst, Adithya Cattamanchi, Beate Kampmann, Devan Jaganath, Eric Wobudeya
{"title":"A Prospective Evaluation of a Three-Gene Host Response Signature to Classify Tuberculosis Severity in Children.","authors":"Brittney Sweetser, Esin Nkereuwem, Jascent Nakafeero, Marie Gomez, Peter Wambi, Moses Nsereko, Alfred Andama, Joel D Ernst, Adithya Cattamanchi, Beate Kampmann, Devan Jaganath, Eric Wobudeya","doi":"10.1093/jpids/piaf041","DOIUrl":"10.1093/jpids/piaf041","url":null,"abstract":"<p><strong>Background: </strong>Children with non-severe TB may benefit from short-course treatment, but point-of-care tools are needed to stratify disease severity. We prospectively evaluated the Cepheid Xpert MTB-Host Response (HR) prototype cartridge for distinguishing TB severity in children with pulmonary TB (PTB) in The Gambia and Uganda.</p><p><strong>Methods: </strong>We included children <15 with microbiologically confirmed or clinically diagnosed unconfirmed PTB. Severity was defined using the World Health Organization (WHO) guidelines for a four-month, drug-susceptible regimen. Capillary or venous blood was tested with the HR cartridge for PCR-based detection of 3 mRNA genes and calculation of a TB score from cycle thresholds. We generated receiver operating characteristic curves with the TB score to classify severe TB and assessed if Xpert-HR could achieve the WHO target accuracy for treatment optimization (≥90% sensitivity, ≥70% specificity).</p><p><strong>Results: </strong>Among 106 children, the median age was 4 years (IQR 1-7), 56.6% were female, and 13.2% were living with HIV. In all children with PTB, Xpert-HR achieved an AUC of 0.67 (95% CI 0.55-0.78), with 89.3% sensitivity (95% CI 71.8-97.7) and 29.5% specificity (95% CI 19.7-40.9, cutoff ≤ -0.60). By confirmation status, Xpert-HR approached the target accuracy in children with Confirmed TB, with 62.5% specificity (95% CI 24.5-91.5) at 91.7% sensitivity (95% CI 61.5-99.8, cut-off ≤ -1.349). Among children with Unconfirmed TB, specificity was lower (24.3%, 95% CI 14.8-36.0) at 93.8% sensitivity (95% CI 69.8-99.8, cutoff ≤ -0.450). Target accuracy was almost achieved in children 5-9 regardless of confirmation status (100% sensitivity [95% CI 71.5-100], 66.7% specificity [95% CI 43.0-85.4], cutoff ≤ -1.35), but specificity (28.2%, 95% CI 18.6-39.5) was lower for children < 5 (92.9% sensitivity, 95% CI 76.5-99.1, cutoff ≤ -0.550).</p><p><strong>Conclusions: </strong>Xpert-HR approached the target accuracy to stratify PTB severity in older children and those with Confirmed TB but had lower specificity in children with Unconfirmed TB. Child-specific signatures may be needed to improve performance in younger children with paucibacillary disease.</p>","PeriodicalId":17374,"journal":{"name":"Journal of the Pediatric Infectious Diseases Society","volume":" ","pages":""},"PeriodicalIF":2.5,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12117649/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143971119","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}