Infection In Young Infants Research Articles

Paid Family Leave and Prevention of Acute Respiratory Infections in Young Infants

Acute respiratory tract infections are the leading cause of emergency department visits and hospitalizations in US children, with highest risks in the first 2 months after birth. Out-of-home childcare settings increase the spread of respiratory tract infections. The study team hypothesized that access to state-paid family leave could reduce acute care encounters (hospital admissions or emergency department visits) for respiratory tract infections in young infants by reducing out-of-home childcare transmissions. To determine if the 2018 introduction of paid family leave in New York state reduced acute care encounters for respiratory tract infections in infants 8 weeks or younger. This population-based study of acute care encounters took place in New York state and New England control states (Maine, Massachusetts, New Hampshire, Vermont) from October 2015 through February 2020. Participants included infants aged 8 weeks or younger. Controlled time series analysis using Poisson regression was used to estimate the impact of paid family leave on acute care encounters for respiratory tract infections, comparing observed counts during respiratory virus season (October through March) with those predicted in the absence of the policy. Acute care encounters for respiratory tract infections in 1-year-olds (who would not be expected to benefit as directly from the policy) were modeled as a placebo test. New York State Paid Family Leave policy, introduced on January 1, 2018, providing 8 weeks of paid leave for eligible parents. Emergency department visits or hospitalizations with International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD) codes for upper or lower respiratory tract infections or associated symptoms (ie, fever, cough), excluding newborn hospitalizations. The secondary outcome was acute care encounters for respiratory syncytial virus (RSV) bronchiolitis. There were 52 943 acute care encounters for respiratory infection among infants 8 weeks or younger. There were 15 932 encounters that were hospitalizations (30%) and 33 304 of the encounters were paid for by Medicaid (63%). Encounters were 18% lower than predicted (relative percentage change = -17.9; 95% CI, -20.3 to -15.7) after the introduction of paid family leave. RSV encounters were 27.0% lower (95% CI, -30.9 to -23.5) than predicted. Similar reductions were not observed in 1-year-olds (relative percentage change = -1.5; 95% CI, -2.5 to -0.6). New York state's paid family leave policy was associated with reduced acute care encounters for respiratory tract infections in young infants. These findings may be useful for informing implementation of paid family leave federally and in the states that have not enacted paid family leave policies.

Severe and invasive bacterial infections in infants aged less than 90 days with and without SARS-CoV-2 infection

BackgroundFever in children represents one of the most common causes of medical evaluation. Infants younger than 90 days of age are at higher risk of severe and invasive bacterial infections (SBI and IBI). However, clinical signs and symptoms of viral and bacterial infections in young infants are frequently similar, and several studies have shown that the risk of SBIs remains non-negligible even in the presence of a positive point-of-care viral test. Our study aims to evaluate whether the proportion of SBIs and IBIs in febrile infants younger than 90 days during the COVID-19 pandemic was higher than that in the pre-pandemic period, and to describe the proportion of SBIs and IBIs in infants with and without SARS-CoV-2 infection.MethodsThis was a retrospective single-center cohort study conducted at the Children's Hospital of the University of Padua in Italy, involving febrile young infants evaluated in the Pediatric Emergency Department (PED) and admitted to Pediatric Acute Care Unit (PACU) between March 2017 to December 2022. Infants admitted before the COVID-19 pandemic were compared to infants admitted during the pandemic period and SARS-CoV-2 positive patients to the negative ones.Results442 febrile infants younger than 90 days were evaluated in Padua PED and admitted to the wards. The proportion of SBIs and IBIS did not significantly change over the study periods, ranging between 10.8% and 32.6% (p = 0.117) and between 0% and 7.6%, respectively (p = 0.367). The proportion of infants with a diagnosis of SBIs and IBIs was higher in the SARS-CoV-2 negative group (30.3% and 8.2%, respectively) compared to the positive group (8.5% and 2.8%, respectively) (p < 0.0001). The most common diagnosis in both groups was UTI, mainly caused by E. coli. A similar proportion of blood and urine cultures were performed, whereas lumbar puncture was more frequently performed in SARS-CoV-2 negative infants (40.2% vs 16.9%, p = 0.001).ConclusionsAlthough the risk of concomitant serious bacterial infection with SARS-CoV-2 is low, it remains non-negligible. Therefore, even in SARS-CoV-2-positive febrile infants, we suggest that the approach to screening for SBIs remains cautious.

Examining Clinical Features and Severe Neurologic Disease of Parechovirus Infection in Young Infants: A Multi-State Cohort Study.

Human parechovirus (HPeV) infection can result in severe disease in infants, including sepsis, seizures, brain injury, and death. In 2022, a resurgence of HPeV was noted in young infants. Spectrum of illness and outcomes remain to be fully described. A multi-state retrospective cohort study was conducted to evaluate hospitalizations and outcomes of infants aged ≤6 months admitted in 2022 with laboratory-confirmed HPeV infection. Infants with severe disease were defined as having clinical seizures, or abnormalities on MRI or EEG during admission. Infants with severe vs non-severe disease were compared using descriptive statistics. 124 U.S. infants were identified with HPeV in 11 states. Cases of HPeV peaked in May and presented at a median of 25.8 days of life (0-194 d) with fever, fussiness, and poor feeding. Bacterial and other viral co-infections were rare. 33 (27%) of infants had severe neurologic disease, were more likely to present at an earlier age (13.9 vs 30 days of life, p<0.01), have preterm gestation (12% vs. 1%, p = 0.02), and present with respiratory symptoms (26% vs. 8%, p = 0.01) or apnea (41% vs. 1%, p <0.001). Subcortical white matter cytoxic cerebral edema was common in severe cases. Two infants with HPeV died during admission with severe neurologic HPeV disease; no infant with mild HPeV disease died. This is the largest, geographically-diverse U.S. study to describe the 2022 HPeV outbreak among infants. Longitudinal follow up of infants is needed to define predictors and outcomes of severe HPeV disease.

Efficacy of Antibiotic Regimens for Sepsis or Possible Serious Bacterial Infection in Young Infants Aged 0 to 59 Days: A Systematic Review and Meta-analysis.

Sepsis is a leading cause of young infant mortality. To evaluate the efficacy of different antibiotic regimens to treat young infant sepsis or possible serious bacterial infection (PSBI) on clinical outcomes. MEDLINE, Embase, CINAHL, World Health Organization Global Index Medicus, Cochrane Central Registry of Trials. We included randomized controlled trials (RCTs) of young infants 0 to 59 days with sepsis or PBSI (population) comparing the efficacy of antibiotic regimens (intervention) with alternate regimens or management (control) on clinical outcomes. We extracted data and assessed risk of bias in duplicate. We performed random-effects meta-analysis, and used Grading of Recommendations, Assessment, Development, and Evaluation to assess certainty of evidence. Of 2390 publications, we included 41 RCTs (n = 18 054). Thirty-five trials were hospital-based and 6 were nonhospital-based. Meta-analysis of 4 trials demonstrated similar rates of treatment success with intramuscular/intravenous third generation cephalosporins versus intramuscular/intravenous penicillin or ampicillin + gentamicin (RR 1.03, 95% CI 0.93-1.13]; n = 1083; moderate certainty of evidence). Meta-analysis of 3 trials demonstrated similar rates of treatment failure with oral amoxicillin + intramuscular gentamicin versus intramuscular penicillin + gentamicin for nonhospital treatment of clinical severe illness (RR 0.86, 95% CI 0.72-1.02]; n = 5054; low certainty of evidence). Other studies were heterogeneous. RCTs evaluated heterogeneous regimens, limiting our ability to pool data. We found limited evidence to support any single antibiotic regimen as superior to alternate regimens to treat young infant sepsis or PSBI.

Global Management of Serious Bacterial Infections in Young Infants Aged 0 to 59 Days: An Overview of Systematic Reviews.

To inform World Health Organization guidelines for the management of serious bacterial infection (SBI) (suspected or confirmed sepsis, pneumonia, or meningitis) in infants aged 0-59 days. To conduct an "overview of systematic reviews" to: (1) understand which systematic reviews have examined diagnosis and management of SBI in infants aged 0-59 days in the last 5 years; and (2) assess if the reviews examined PICOs (population, intervention, comparator, outcomes) and regimens currently being recommended in low and middle income countries (LMICs) by the World Health Organization. MEDLINE; Embase; Cochrane Library; Epistemonikos; PROSPERO. Systematic reviews of randomized controlled trials or observational studies of infants aged 0-59 days examining diagnostic accuracy and antibiotic regimens for SBI from January 1, 2018 to November 3, 2023. Dual independent extraction of study characteristics, PICOs, and methodological quality. Nine systematic reviews met our criteria. Two reviews examined diagnostic accuracy for sepsis, and no reviews examined pneumonia or meningitis. Five reviews examined antibiotic effectiveness (sepsis [n = 4]; pneumonia [n = 1]), and no reviews examined meningitis. One review examined antibiotic duration for sepsis and one for meningitis, and no reviews for pneumonia. Only 4 of the 9 systematic reviews met criteria for high-quality. Our review was limited to the last 5 years to inform current guideline updates. Few studies have examined antibiotic regimens currently being used in LMICs and quality is of concern in many studies. More high-quality data are needed to inform management of SBI in newborns, especially in LMICs.

Introduction to Evidence for Global Management of Serious Bacterial Infections in Young Infants Aged 0-59 Days.

Introduction to Evidence for Global Management of Serious Bacterial Infections in Young Infants Aged 0-59 Days.

Reducing IV Antibiotic Duration for Neonatal UTI Using a Clinical Standard Pathway.

Urinary tract infections (UTIs) are the most common bacterial infections in young infants and are traditionally treated with longer intravenous (IV) antibiotic courses. A growing body of evidence supports shorter IV antibiotic courses for young infants. Our primary aim was to decrease the IV antibiotic treatment to 3 days over 2 years for neonates aged 0 to 28 days who have been hospitalized with UTIs. Using quality improvement methods, our primary intervention was to implement a revised clinical pathway recommending 3 (previously 7) days of IV antibiotics. Our primary outcome measure was IV antibiotic duration, and the secondary outcomes were length of stay (LOS) and costs. The balancing measure was readmission within 30 days of discharge. Neonates were identified by using International Classification of Diseases diagnosis codes and excluded if they were admitted to the ICU or had a LOS >30 days. We used statistical process control to analyze outcome measures for 4 years before (baseline) and 2 years after the pathway revision (intervention) in February 2020. A total of 93 neonates were hospitalized with UTIs in the baseline period and 41 were hospitalized in the intervention period. We found special cause variation, with a significant decrease in mean IV antibiotic duration from 4.7 (baseline) to 3.1 days (intervention) and a decrease in mean LOS from 5.4 to 3.6 days. Costs did not differ between the baseline and intervention periods. There were 7 readmissions during the baseline period, and 0 during the intervention period. The implementation of a revised clinical pathway significantly reduced IV antibiotic treatment duration and hospital LOS for neonatal UTIs without an increase in hospital readmissions.

Urinary tract infections in young infants with a normal urine dipstick.

To assess missed urinary tract infections (UTI) in febrile infants ≤2 months when adhering to recent guidelines suggesting not to send a urine culture with a negative dipstick. A retrospective cohort study of 308 infants ≤2 months with a positive urine culture admitted in 2013-2023, divided into subgroups without exposure to urine dipstick results: 'urosepsis' (UTI with bacteraemia), 'UTI' (positive urine culture, elevated inflammatory markers, no other cause of fever) and 'bacteriuria' (positive urine culture, not meeting the above-mentioned criteria). After retrieving the dipstick results, the 'missed UTI' group (UTI+ negative dipstick) was described. A negative dipstick was found in 2/20 (10%), 32/127 (25%) and 126/161 (78%) of infants with 'urosepsis', 'UTI' and 'bacteriuria', respectively. In the 'missed UTI' group (n = 34), there were more non-Escherichia coli UTI (68% vs. 9% with positive dipstick, p < 0.001), and lower inflammatory markers (leukocytes 15.5 vs. 17.2 k/μL, p = 0.007, C-reactive protein 21 vs. 58 mg/L, p < 0.001). Three infants had high-grade vesicoureteral reflux (VUR) and renal scarring. There is a non-negligible rate of infants ≤2 months with UTI and without pyuria, including those with urosepsis, VUR and renal scarring. We suggest obtaining a urine culture regardless of dipstick results.

Respiratory Syncytial Virus-Associated Respiratory Diseases in Children and Adults.

Respiratory syncytial virus (RSV) is a common cause of lower respiratory tract infections (LRTI), particularly in neonates, infants and young children, with approximately 33 million infections worldwide each year. 1-2% of episodes lead to hospitalization. There are hardly any reliable epidemiological figures on hospital - ization in adults, whose burden of disease from RSV is probably markedly underestimated. This review is based on publications retrieved by a selective search in PubMed, with particular attention to recommendations for the prevention of RSV infection. There is no approved antiviral therapy for clinical practice, but preventive strategies are increasingly becoming available. Passive immunization in infants is well tolerated and highly effective, as is the active vaccination of pregnant women to prevent severe RSV infection in young infants. The former was found to lower the frequency of severe LRTI (5/4037 in the vaccination group vs. 19/4031 individuals in the placebo group), yielding an efficacy of 75.7%; for the latter, the corresponding findings were a reduction to 19/3682 in the vaccination group vs. 62/3676 in the placebo group, or 69.4% efficacy. For the active vaccination of older adults, both a recombinant vaccine with adjuvant and a bivalent vaccine have recently been approved. These, too, are well tolerated and highly effective: the former lowered the frequency of severe LRTI to 1/12466 in the vaccination group vs. 17/12494 in the placebo group (94.1% efficacy), while the latter lowered the frequency of LRTI with 3 or more manifestations to 2/17215 in the vaccination group vs. 14/17069 in the placebo group (85.7% efficacy). The approval of new RSV-specific monoclonal antibodies and active vaccinations enables targeted prevention of RSV infection in the main population groups at risk.

Uropathogens and clinical manifestations of pyuria-negative urinary tract infections in young infants: A single center cross-sectional study

BackgroundUrine leukocyte count under microscopy is one of the most frequently used routine screening tests for urinary tract infection (UTI). Nevertheless, it is observed that pyuria is lacking in 10-25% of children with UTI. This study aims to determine the factors related to pyuria-negative UTI in young infants aged under four months old. MethodThis retrospective cross-sectional study was conducted on 157 patients aged under 4 months old with UTI. All subjects had paired urinalysis and urine culture, which were collected via transurethral catheterization. According to the results of their urinalysis, the patients were then classified as UTI cases with pyuria and UTI cases without pyuria. The clinical characteristics and outcomes of both groups were analyzed. ResultAmong the 157 UTI patients, the prevalence of pyuria-negative UTI was 44%. Significant risk factors associated with pyuria-negative UTI included non-E.coli pathogens, younger age, shorter duration of fever prior to hospital visit, lower white blood cell (WBC) count upon hospital visit, and absence of microscopic hematuria. ConclusionsWe found that non-E.coli uropathogens were the strongest factor related to pyuria-negative UTI. The absence of pyuria cannot exclude the diagnosis of UTI in young infants, and it’s reasonable to perform both urinalysis and urine culture as a part of the assessment of febrile or ill-looking young infants.

Host RNA Expression Signatures in Young Infants with Urinary Tract Infection: A Prospective Study.

Early diagnosis of infections in young infants remains a clinical challenge. Young infants are particularly vulnerable to infection, and it is often difficult to clinically distinguish between bacterial and viral infections. Urinary tract infection (UTI) is the most common bacterial infection in young infants, and the incidence of associated bacteremia has decreased in the recent decades. Host RNA expression signatures have shown great promise for distinguishing bacterial from viral infections in young infants. This prospective study included 121 young infants admitted to four pediatric emergency care departments in the capital region of Denmark due to symptoms of infection. We collected whole blood samples and performed differential gene expression analysis. Further, we tested the classification performance of a two-gene host RNA expression signature approaching clinical implementation. Several genes were differentially expressed between young infants with UTI without bacteremia and viral infection. However, limited immunological response was detected in UTI without bacteremia compared to a more pronounced response in viral infection. The performance of the two-gene signature was limited, especially in cases of UTI without bloodstream involvement. Our results indicate a need for further investigation and consideration of UTI in young infants before implementing host RNA expression signatures in clinical practice.

Risk factors for recurrent urinary tract infections in young infants under the age of 24 months

Purpose: Recurrent urinary tract infections (UTIs) in children is a major challenge for pediatricians. This study was designed to investigate the risk factors for recurrent UTIs and determine the association between recurrent UTIs and clinical findings, including growth patterns in infants and children younger than 24 months of age. Methods: We retrospectively reviewed the medical records of 147 patients &lt;24 months of age with UTIs who were hospitalized between August 2018 and October 2021. The patients were divided into recurrent and single UTI episode groups. Clinical findings and anthropometric and laboratory data were compared between the two groups.Results:In the recurrent UTI group, the weight-for-length (WFL) percentile at the first UTI diagnosis was lower compared to the single UTI episode group, and the weight-for-age percentile at 3-month and 6-month follow-ups after the first UTI decreased (all P&lt;0.05). In univariable logistic regression analysis, higher birth weight, lower WFL percentile, the presence of hydronephrosis, acute pyelonephritis or vesicoureteral reflux, the use of prophylactic antibiotics, and non-Escherichia coli infections were associated with the development of recurrent UTIs (all P&lt;0.05). However, in the multivariable analysis, only the presence of hydronephrosis and prophylactic antibiotic use were independently related to UTI recurrence (P&lt;0.05). Conclusion: The presence of hydronephrosis at the first UTI can be helpful for predicting UTI recurrence in young children aged &lt; 24 months. Antibiotic prophylaxis may be associated with UTI recurrence. Potential growth delay should be carefully monitored in infants with recurrent UTI.

Incidence of possible serious bacterial infection in young infants in the three high-burden countries of the Democratic Republic of the Congo, Kenya, and Nigeria: A secondary analysis of a large, multi-country, multi-centre clinical trial.

Neonatal infections are a major public health concern worldwide, particularly in low- and middle-income countries, where most of the infection-related deaths in under-five children occur. Sub-Saharan Africa has the highest mortality rates, but there is a lack of data on the incidence of sepsis from this region, hindering efforts to improve child survival. We aimed to determine the incidence of possible serious bacterial infection (PSBI) in young infants in three high-burden countries in Africa. This is a secondary analysis of data from the African Neonatal Sepsis (AFRINEST) trial, conducted in the Democratic Republic of the Congo (DRC), Kenya, and Nigeria between 15 March 2012 and 15 July 2013. We recorded baseline characteristics, the incidence of PSBI (as defined by the World Health Organization), and the incidence of local infections among infants from 0-59 days after birth. We report descriptive statistics. The incidence of PSBI among 0-59-day-old infants across all three countries was 11.2% (95% confidence interval (CI) = 11.0-11.4). The DRC had the highest incidence of PSBI (19.0%; 95% CI = 18.2-19.8). Likewise, PSBI rates were higher in low birth weight infants (24.5%; 95% CI = 23.1-26.0) and infants born to mothers aged <20 years (14.1%; 95% CI = 13.4-14.8). The incidence of PSBI was higher among infants delivered at home (11.7%; 95% CI = 11.4-12.0). The high burden of PSBI among young infants in DRC, Kenya, and Nigeria demonstrates the importance of addressing PSBI in improving child survival in sub-Saharan Africa to reach the Sustainable Development Goals (SDGs). These data can support government authorities, policymakers, programme implementers, non-governmental organisations, and international partners in reducing preventable under-five deaths. Australian New Zealand Clinical Trials Registry: ACTRN12610000286044.

1747. Clinical Spectrum of a Large Multi-State U.S. Cohort of Parechovirus Infection in Neonates and Young Infants

Abstract Background Severe manifestations of human parechovirus (HPeV) infection, including meningoencephalitis and sepsis, can occur in neonates and young infants. Death has rarely been reported. Rates of HPeV infection fluctuate from year to year in the community. After the home isolation during the initial COVID-19 era in 2020, waves of respiratory viral outbreaks at unusual times of the year were identified in the pediatric community in 2021 and 2022, including increased number of cases of severe HPeV infection in young infants. This study characterizes the U.S. outbreak of HPeV infections that occurred in newborns and young infants in 2022. Methods A multi-site, retrospective and prospective observational study identified hospitalized infants &amp;lt; =6 months, with a body fluid specimen positive for HPeV. IRB approval of a single protocol was obtained at each site. Data obtained included hospital summary, maternal and birth history, medications, bacterial and viral testing, and radiology results. Analysis included infants with hospitalizations from January 1 through December 31, 2022. Results 13 academic sites were enrolled, which included 8 sites achieving full IRB approval/activation and completed data collection, and 5 sites pending activation [Fig 1A]. Interim analysis shows 112 infants across eleven states hospitalized with HPeV infection with a median hospital duration of 3 days (range 0-178 d), peaking in May 2022 [Fig 1B], with a spectrum of biochemical markers [Table 1]. The median age at hospitalization was 21.5 days of life (IQR 10, 32 d). All but five infants received antibiotics during the admission, and more than half (54%) received acyclovir. Other pathogens were rarely reported [Table 2]. 45 (38%) infants received MRI brain imaging during hospitalization of which 29 were abnormal; 10 reports directly mentioning HPeV in the interpretation. A total of 51 EEGs were completed in 31 infants; 20 infants (18%) had seizures reported. 17 infants required anticonvulsants. Two infants died. Conclusion We report the first multi-site, clinical description of the 2022 U.S. outbreak of HPeV among neonates and young infants. This is the first large series of infants with HPeV to report mortality. Further development of a multi-site U.S. collaboration to improve surveillance for HPeV is needed. Disclosures Laura Filkins, PhD, Avsana Labs: Board Member|Avsana Labs: Stocks/Bonds|Biofire Diagnostics: Grant/Research Support Claudia M. Espinosa, MD, MSc, AstraZeneca: Grant/Research Support|Enanta: Grant/Research Support|Jansen and Jansen: Advisor/Consultant|Kentucky Rural Health Association: Honoraria|Merck: Grant/Research Support|Sanofi: Advisor/Consultant|Sanofi: Grant/Research Support|Sanofi: Honoraria|Sobi: Dinner Joseph A. Bocchini, Jr., MD, Avalere: Advisor/Consultant|Enanta: Site PI on multicenter clinical trials, contract with employer|Moderna: Advisor/Consultant|Novavax: Sub-I on multicenter clinical trials, contract with employer|Pfizer: Advisor/Consultant|Pfizer: Site PI on multicenter clinical trials, contract with employer|Regeneron: Site PI on multicenter clinical trials, contract with employer|Sobi: Advisor/Consultant|Valneva: Advisor/Consultant Roberto P. Santos, MD, MSCS, Eli Lilly (SARS-CoV-2, baricitinid) - Site Open for Enrollment on March 8, 2023: Industry-sponsored clinical trials with research contract awarded to the University of Mississippi Medical Center with RPS as site PI|Eli Lilly (SARS-CoV-2, LY3819253, LY3832479) - study discontinuation on January 3, 2022: Industry-sponsored clinical trials with research contract awarded to the University of Mississippi Medical Center with RPS as site PI|JNJ (RSV, rilematovir) - study discontinuation on March 1, 2022: Industry-sponsored clinical trials with research contract awarded to the University of Mississippi Medical Center with RPS as site PI|MSD (HIV, islatravir, doravirine) - study discontinuation on December 6, 2022: Industry-sponsored clinical trials with research contract awarded to the University of Mississippi Medical Center with RPS as site PI Rangaraj Selvarangan, BVSc, PhD, D(ABMM), FIDSA, FAAM, Abbott: Honoraria|Altona Diagnostics: Grant/Research Support|Baebies Inc: Advisor/Consultant|BioMerieux: Advisor/Consultant|BioMerieux: Grant/Research Support|Bio-Rad: Grant/Research Support|Cepheid: Grant/Research Support|GSK: Advisor/Consultant|Hologic: Grant/Research Support|Lab Simply: Advisor/Consultant|Luminex: Grant/Research Support David W. Kimberlin, MD, Gilead: Grant/Research Support|Gilead: I served as site PI on Gilead's study of remdesivir in pediatric patients. All monies went directly to my university and not to me.

HUMAN PARECHOVIRUS CENTRAL NERVOUS SYSTEM INFECTION IN A YOUNG INFANT COHORT.

In 2022, a surge in cases of pediatric human parechovirus (HPeV) central nervous system infections in young infants was seen at our institution. Despite the dramatic increase in the number of cases seen that year, the clinical features of the illness were similar to prior years. The recent pediatric HPeV surge highlights the need to evaluate treatment options and standardize follow-up to better understand the long-term prognosis of infants with HPeV infection.

Care-seeking behaviours of mothers and associated factors for possible serious bacterial infection in young infants during COVID-19 pandemic in Ethiopia: mixed-methods formative research

ObjectivesImplementation research was employed to examine rates and contextual factors associated with mothers’ care-seeking for their sick neonates and identify challenges for community-based possible serious bacterial infection (PSBI) services access...

Unusual presentation of Campylobacter diarrhea in a 12-week-old infant: a case report

Campylobacter infection is a common cause of bacterial gastroenteritis in children. However, it typically presents with symptoms such as fever, diarrhea, and abdominal pain. We reported an unusual case of Campylobacter diarrhea in a 12-week-old infant who initially presented with decreased appetite and blood in stool, without fever or diarrhea. Then subsequently infant had developed fever and diarrhea. The case highlights the importance of considering atypical presentations of Campylobacter infection in young infants, leading to timely diagnosis and appropriate management.

Lessons learnt from community referral and follow up of sick young infants with possible severe bacterial infection in Turkana County, Kenya

IntroductionManagement of possible severe bacterial infections in young infants (0–59 days) requires timely identification of danger signs and prompt administration of efficacious antibiotic treatment. The Possible Severe Bacterial Infection guidelines underscore the importance of close follow up in an outpatient basis to ensure treatment adherence and early detection of illness-related complications. The purpose of this study was to strengthen the follow up and referral of sick young infants on day 4 and 8 by introducing community-led interventions that facilitated community health volunteers to identify sick young infants, conduct community reviews, link data with responsive facilities, and refer appropriately. MethodsSix health facilities were included in a longitudinal, descriptive, mixed methods approach weaved around an initial formative context assessment and three-monthly assessments between October 2019 to January 2020 with a endline assessment in August 2020. Quantitative data was extracted from facility registers to identify gaps in follow up and referral feasibility. Qualitative data was through focus group discussions with community health volunteers and key informant interviews with frontline providers. ResultsQualitative data provided insights into key barriers and facilitators of community follow up and referral. Barriers include community socio-cultural practices, competing tasks, dysfunctional community referral pathway, drivers of common infections, and unavailability of essential commodities. Key facilitators entail indication of competency in identification of danger signs in sick young infants, presence of older women, men, and community resource persons that can leveraged on in community engagement and sensitization, and mothers are the primary decision makers in care seeking. There was increased utilization of decision support tools and an increase in the number of sick young infants managed in dispensaries. The COVID-19 pandemic however negatively impacted community follow up and referral of sick young infants. ConclusionEssential barriers and facilitators to follow up and community referral entwined with facility-based vulnerabilities were highlighted. A two-pronged intervention on improving communication, linkage and subsequent follow up of sick young infants was employed in the six participating facilities. The feasibility, adoption, and fidelity of strengthening community facility linkage through integrated communication strategies was documented, indicative of a successful community-facility linkage in dispensaries and health centers despite the effects of the COVID-19 pandemic.

Responding to Higher-Than-Expected Infant Mortality Rates from Respiratory Syncytial Virus (RSV): Improving Treatment and Reporting Strategies.

Respiratory syncytial virus (RSV) has a major role in respiratory infections in young infants around the world. However, substantial progress has been made in recent years in the field of RSV. A wide variety of observational studies and clinical trials published in the past decade provide a thorough idea of the health and economic burden of RSV disease in the developing world. In this review, we discuss the impact of RSV burden of disease, major gaps in disease estimations, and challenges in generating new therapeutic options and an immune response against the virus, and briefly describe next generation technologies that are being evaluated.

2134. A Phase 2 Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Booster Dose of a Group B Streptococcus 6-Valent Polysaccharide Conjugate Vaccine (GBS6)

Abstract Background Group B streptococcus (GBS) is a leading cause of invasive bacterial infections in young infants and pregnant women. Pfizer is developing a hexavalent GBS vaccine (GBS6) as a maternal vaccine to prevent invasive GBS disease due to the 6 most prevalent serotypes in young infants. We previously reported Phase 1 safety and immunogenicity data for GBS6. There is precedent for repeat doses of vaccines to augment or sustain circulating antibodies available for placental transfer with each pregnancy; thus, data to inform GBS6 booster strategies were required. Methods This was a Phase 2 open-label extension study to evaluate the safety and immunogenicity of a booster dose of GBS6 (20 μg capsular polysaccharide (CPS)/serotype/dose) with or without AlPO4, given ∼2 years after primary vaccination in 151 healthy nonpregnant adults. Sera taken before and 1-month postbooster were assessed for anti-CPS IgG using a direct Luminex immunoassay. Participants recorded solicited local and systemic events for 14 days after vaccination and unsolicited safety events through 6 months after vaccination. Immunogenicity time points from the Phase 1 study are referred to as primary dose. Results Immunogenicity results For all serotypes, serotype-specific IgG geometric mean concentrations (GMCs) remained elevated compared to baseline at the prebooster time point and were higher 1-month postbooster than 1 month post primary. The 1-month postbooster IgG GMCs were 10- to 59-fold higher than at the prebooster time point. There were similar responses between the 2 formulations. Safety and tolerability results The most frequently reported local reaction was mild to moderate pain at the injection site. Greater pain was associated with AlPO4 formulation. The most frequently reported systemic events were mild to moderate headache and fatigue. The frequency of adverse events was low. Figure 1Antibody Response Line Plot of IgG GMCs by Vaccine Group - All SerotypesFigure 2.Reverse Cumulative Distribution Curves (RCDCs) for IgG 1 Month After Primary and Booster Vaccination, by Vaccine Group – All SerotypesFigure 3.IgG Geometric Mean Fold Rises (GMFRs) at 1 Month Postbooster Vaccination Conclusion A booster dose of GBS6 given ∼2 years after a primary dose to healthy nonpregnant adults was safe and elicited robust immune responses that were also consistently higher than after primary dose. This study suggests that repeat vaccination with GBS6 may confer additional benefit in pregnant women in subsequent pregnancies. Disclosures Babalwa Jongihlati, MD, MBA, Pfizer: Stocks/Bonds Judith Absalon, MD, MPH, Pfizer: Stocks/Bonds Samantha Munson, MPH, MBA, Pfizer: Stocks/Bonds Yasmin Sanchez-Pearson, PhD, Pfizer: Stocks/Bonds Raphael Simon, PhD, Pfizer: Stocks/Bonds Natalie Silmon de Monerri, PhD, Pfizer: Stocks/Bonds David Radley, MS, Pfizer: Employee|Pfizer: Stocks/Bonds Emily A. Gomme, Ph.D., Pfizer: Stocks/Bonds Michelle Gaylord, PhD, Pfizer: Stocks/Bonds William C. Gruber, MD, Pfizer, Inc.: Salary|Pfizer, Inc.: Stocks/Bonds Kathrin U. Jansen, PhD, Pfizer: Stocks/Bonds Daniel A. Scott, MD, Pfizer: Employee|Pfizer: Stocks/Bonds Annaliesa S. Anderson, PhD, Pfizer: Stocks/Bonds.