Interventions to de-implement unnecessary antibiotic prescribing for ear infections (DISAPEAR Trial): protocol for a cluster-randomized trial DOI Creative Commons
Timothy C Jenkins, Amy Keith, Joshua Epstein

et al.

BMC Infectious Diseases, Journal Year: 2024, Volume and Issue: 24(1)

Published: Jan. 24, 2024

Abstract Background Watchful waiting management for acute otitis media (AOM), where an antibiotic is used only if the child’s symptoms worsen or do not improve over subsequent 2–3 days, effective approach to reduce exposure children with AOM. However, studies compare effectiveness of interventions promote watchful are lacking. The objective this study and implementation outcomes two pragmatic, patient-centered designed facilitate use in clinical practice. Methods This will be a cluster-randomized trial utilizing hybrid implementation-effectiveness design. Thirty-three primary care urgent clinics randomized one interventions: health systems-level intervention alone combined shared decision-making aid. include engagement clinician champion at each clinic, changes electronic record orders delayed prescriptions as part strategy, quarterly feedback reports detailing clinicians’ individually compared peers, virtual learning sessions clinicians. plus aid inform between parents clinicians best available evidence. whether was ultimately taken by child parent satisfaction their care. We explore differences patient population served, clinic type, setting, organization. fidelity, acceptability, perceived appropriateness among different types, populations, settings compared. also conduct formative qualitative interviews surveys administrators, focus groups patients AOM, stakeholder advisory councils further interventions. Discussion pragmatic AOM increase satisfaction, thus informing national stewardship policy development. Clinical registration NCT06034080.

Language: Английский

Use of 15-Valent Pneumococcal Conjugate Vaccine Among U.S. Children: Updated Recommendations of the Advisory Committee on Immunization Practices — United States, 2022 DOI Open Access

Miwako Kobayashi,

Jennifer L. Farrar,

Ryan Gierke

et al.

MMWR Morbidity and Mortality Weekly Report, Journal Year: 2022, Volume and Issue: 71(37), P. 1174 - 1181

Published: Sept. 15, 2022

The 13-valent pneumococcal conjugate vaccine (PCV13 [Prevnar 13, Wyeth Pharmaceuticals, Inc, a subsidiary of Pfizer, Inc]) and the 23-valent polysaccharide (PPSV23 [Merck Sharp & Dohme LLC]) have been recommended for U.S. children, recommendations vary by age group risk (1,2). In 2021, 15-valent (PCV15 [Vaxneuvance, Merck was licensed use in adults aged ≥18 years (3). On June 17, 2022, Food Drug Administration (FDA) approved an expanded usage PCV15 to include persons 6 weeks-17 years, based on studies that compared antibody responses with those PCV13 (4). contains serotypes 22F 33F (in addition serotypes) conjugated CRM197 (genetically detoxified diphtheria toxin). 22, CDC's Advisory Committee Immunization Practices (ACIP) as option vaccination <19 according currently dosing schedules ACIP employed Evidence Recommendation (EtR) Framework,* using Grading Recommendations, Assessment, Development Evaluation (GRADE)† approach guide its deliberations regarding these vaccines. Risk-based PPSV23 2-18 certain underlying medical conditions§ increase disease not changed.

Language: Английский

Citations

67
Epidemiological characteristics and antibiotic resistance mechanisms of Streptococcus pneumoniae: An updated review DOI Creative Commons
Lifeng Li, Jiayue Ma,

Zengyuan Yu

et al.

Microbiological Research, Journal Year: 2022, Volume and Issue: 266, P. 127221 - 127221

Published: Oct. 12, 2022

Language: Английский

Citations

54
Identifying Children Likely to Benefit From Antibiotics for Acute Sinusitis DOI
Nader Shaikh, Alejandro Hoberman, Timothy R. Shope

et al.

JAMA, Journal Year: 2023, Volume and Issue: 330(4), P. 349 - 349

Published: July 25, 2023

Importance The large overlap between symptoms of acute sinusitis and viral upper respiratory tract infection suggests that certain subgroups children being diagnosed with sinusitis, subsequently treated antibiotics, derive little benefit from antibiotic use. Objective To assess if therapy could be appropriately withheld in prespecified subgroups. Design, Setting, Participants Randomized clinical trial including 515 aged 2 to 11 years based on criteria. was conducted February 2016 April 2022 at primary care offices affiliated 6 US institutions designed evaluate whether symptom burden differed defined by nasopharyngeal Streptococcus pneumoniae, Haemophilus influenzae , or Moraxella catarrhalis bacterial culture the presence colored nasal discharge. Interventions Oral amoxicillin (90 mg/kg/d) clavulanate (6.4 (n = 254) placebo 256) for 10 days. Main Outcomes Measures outcome daily scores a validated scale (range, 0-40) during days after diagnosis. Secondary outcomes included treatment failure, adverse events clinically significant diarrhea, resource use families. Results Most 510 were 5 (64%), male (54%), White (52%), not Hispanic (89%). mean significantly lower group (9.04 [95% CI, 8.71 9.37]) compared those (10.60 10.27 10.93]) (between-group difference, −1.69 −2.07 −1.31]). length time resolution (7.0 days) than (9.0 ( P .003). Children without pathogens detected did as much detected; between-group difference −0.88 (95% −1.63 −0.12) −1.95 −2.40 −1.51) detected. Efficacy differ according discharge present (the −1.62 −2.09 −1.16] vs −1.70 −2.38 −1.03] clear discharge; .52 interaction discharge). Conclusions In had minimal presentation, its effects depend color Testing specific bacteria presentation may represent strategy reduce this condition. Trial Registration ClinicalTrials.gov Identifier: NCT02554383

Language: Английский

Citations

28
Incidence of acute otitis media in children in the United States before and after the introduction of 7- and 13-valent pneumococcal conjugate vaccines during 1998–2018 DOI Creative Commons
Tianyan Hu, Nicolae Done, Tanaz Petigara

et al.

BMC Infectious Diseases, Journal Year: 2022, Volume and Issue: 22(1)

Published: March 26, 2022

Acute otitis media (AOM) is a leading cause of office visits and antibiotic prescriptions in children. Pneumococcal conjugate vaccines were introduced the USA 2000 (7-valent, PCV7) 2010 (13-valent, PCV13). Expanded valency PCVs are currently under development. To describe impact quantify residual burden AOM, this study estimated annual incidence rates (IRs) AOM AOM-related complications surgical procedures children < 18 years before after introduction PCV7 PCV13.AOM episodes identified IBM MarketScan® Commercial Medicaid databases using diagnosis codes (ICD-9-CM: 382.x; ICD-10-CM: H66.xx H67.xx). Annual IRs calculated as number per 1000 person-years (PYs) for all by age group (< 2, 2-4, 5-17 years). National estimates extrapolated Census Bureau data. Interrupted time series analyses used to assess immediate gradual changes monthly IRs, controlling seasonality.In commercially insured population, declined between pre-PCV7 period (1998-1999) late PCV13 (2014-2018) from 1170.1 768.8 PY 2 years, 547.4 410.3 2-4 115.6 91.8 years. The interrupted indicated significant or decreases early (2001-2005), increases (2006-2009) years; however, crude trended downward periods. In older children, decreased (2011-2013), but gradually increased period. decreased, during timeframe.AOM disease remains high ages despite overall reductions 1998-2018 following PCV13. investigational on will likely depend etiology circulating pneumococcal serotypes.

Language: Английский

Citations

34
Estimating the Cost-Effectiveness of Switching to Higher-Valency Pediatric Pneumococcal Conjugate Vaccines in the United Kingdom DOI Creative Commons
Michele Wilson, A. O. Lucas, Diana Mendes

et al.

Vaccines, Journal Year: 2023, Volume and Issue: 11(7), P. 1168 - 1168

Published: June 28, 2023

Currently, the 13-valent pneumococcal conjugate vaccine (PCV13) is administered under a 1+1 (1 primary dose) pediatric schedule in United Kingdom (UK). Higher-valency PCVs, 15-valent PCV (PCV15), or 20-valent (PCV20) might be considered to expand serotype coverage. We evaluated cost-effectiveness of PCV20 PCV15 using either 2+1 (2 doses) for immunization UK. Using dynamic transmission model, we simulated future disease incidence and costs PCV13 1+1, 2+1, schedules from UK National Health Service perspective. prospectively estimated cases, direct costs, quality-adjusted life-years (QALYs), incremental ratio. Scenario analyses were performed estimate impact model assumptions parameter uncertainty. Over five-year period, averted most cases gained additional QALYs. dominant (cost-saving more QALYs gained) compared with (2+1 1+1) 1+1. was cost-effective (GBP 8110/QALY) found cost-saving Policymakers should consider reduction PCV20, which may offset vaccination costs.

Language: Английский

Citations

16
New insights into the treatment of acute otitis media DOI
Rana E. El Feghaly, Amanda Nedved, Sophie E. Katz

et al.

Expert Review of Anti-infective Therapy, Journal Year: 2023, Volume and Issue: 21(5), P. 523 - 534

Published: April 25, 2023

Acute otitis media (AOM) affects most (80%) children by 5 years of age and is the common reason are prescribed antibiotics. The epidemiology AOM has changed considerably since widespread use pneumococcal conjugate vaccines, which broad-reaching implications for management.

Language: Английский

Citations

14
Outpatient Visits and Antibiotic Use Due to Higher-Valency Pneumococcal Vaccine Serotypes DOI Creative Commons
Laura King, Kristin L. Andrejko, Sarah Kabbani

et al.

The Journal of Infectious Diseases, Journal Year: 2024, Volume and Issue: unknown

Published: March 18, 2024

Abstract Background In 2022–2023, 15- and 20-valent pneumococcal conjugate vaccines (PCV15/PCV20) were recommended for infants. We aimed to estimate the incidence of outpatient visits antibiotic prescriptions in US children (≤17 years) from 2016–2019 acute otitis media, pneumonia, sinusitis associated with PCV15- PCV20-additional (non-PCV13) serotypes quantify PCV15/20 potential impacts. Methods estimated PCV15/20-additional serotype-attributable as product all-cause rates, derived national health care surveys MarketScan databases, fractions. serotype-specific attributable fractions using modified vaccine-probe approaches incorporating changes post-PCV13 ratios PCV13 versus serotype frequencies, through meta-analyses. Results Per 1000 annually, PCV15-additional accounted an 2.7 (95% confidence interval, 1.8–3.9) 2.4 CI, 1.6–3.4) prescriptions. resulted 15.0 11.2–20.4) 13.2 9.9–18.0) annually per children. account 0.4% 0.2%–0.6%) 2.1% 1.5%–3.0%) pediatric use. Conclusions Compared serotypes, &gt; 5 times burden Higher-valency PCVs, especially PCV20, may contribute preventing respiratory infections

Language: Английский

Citations

5
Anticipated Effects of Higher-valency Pneumococcal Conjugate Vaccines on Colonization and Acute Otitis Media DOI Open Access
Ravinder Kaur, Steven Schulz,

Andrew J. Sherman

et al.

The Pediatric Infectious Disease Journal, Journal Year: 2024, Volume and Issue: unknown

Published: June 5, 2024

Background: Bacterial etiologies of acute otitis media (AOM) have shifted from the introduction pneumococcal conjugate vaccines (PCVs), antibiotic selection and competition among species. We characterized Streptococcus pneumoniae ( Spn ), Haemophilus influenzae Hflu ) Moraxella catarrhalis Mcat in nasopharynx during well-child healthy visits at onset AOM, middle ear fluid (MEF) children with AOM to assess anticipated effects higher-valency PCVs (PCV15 PCV20). Methods: From September 2021 2023, we conducted a prospective longitudinal cohort study PCV13 immunized 6–36 months old. MEF was collected via tympanocentesis. Serotyping susceptibility testing were performed on , isolates. Results: obtained 825 nasopharyngeal 216 samples 301 children. The order frequency colonization ; predominant otopathogen MEF. Among isolates, non-PCV15, non-PCV20 serotypes predominated MEF; most frequent serotype 35B. samples, 30% isolates amoxicillin nonsusceptible; 23% 100% β-lactamase-producing. Conclusion: majority young serotypes, especially 35B; therefore, impact reducing or is expected be limited. continues pathogen. Antibiotic data suggest high dose amoxicillin/clavulanate alternative drugs that are effective against contemporary mix otopathogens could considered for optimal empiric provide best efficacy.

Language: Английский

Citations

5
Cost-Effectiveness Analysis of Routine Use of 15-Valent Pneumococcal Conjugate Vaccine in the US Pediatric Population DOI Creative Commons
Min Huang, Tianyan Hu, Jessica Weaver

et al.

Vaccines, Journal Year: 2023, Volume and Issue: 11(1), P. 135 - 135

Published: Jan. 6, 2023

This study evaluated the clinical and economic impact of routine pediatric vaccination with 15-valent pneumococcal conjugate vaccine (PCV15, V114) compared 13-valent PCV (PCV13) from a societal perspective in United States (US). A Markov decision-analytic model was constructed to estimate outcomes for entire US population over 100-year time horizon. The estimated V114 versus PCV13 on disease (PD) incidence, post meningitis sequalae, deaths, taking herd immunity effects into account. effectiveness extrapolated observed data PCV7 trials. Costs (2021$) included acquisition administration costs, direct medical costs PD treatment, non-medical indirect were discounted at 3% per year. In base case, prevented 185,711 additional invasive disease, 987,727 all-cause pneumonia, 11.2 million acute otitis media cases, PCV13. led expected gains 90,026 life years 96,056 quality-adjusted total saving $10.8 billion. Sensitivity analysis showed consistent results plausible values key inputs assumptions. findings suggest that is cost-saving option program.

Language: Английский

Citations

11
The Shifting Landscape of Orbital Complications in the Pneumococcal Vaccine Era: Progress, Paradoxes, and Perspectives DOI Creative Commons

Chun-Hsien Yu

Pediatrics & Neonatology, Journal Year: 2025, Volume and Issue: unknown

Published: Jan. 1, 2025

Language: Английский

Citations

0