Valganciclovir for symptomatic congenital cytomegalovirus disease.

BACKGROUND: The treatment of symptomatic congenital cytomegalovirus (CMV) disease with intravenous ganciclovir for 6 weeks has been shown to improve audiologic outcomes at 6 months, but the benefits wane over time. METHODS: We conducted a randomized, placebo-controlled trial of valganciclovir therapy in neonates with symptomatic congenital CMV disease, comparing 6 months of therapy with 6 weeks of therapy. The primary end point was the change in hearing in the better ear ("best-ear" hearing) from baseline to 6 months. Secondary end points included the change in hearing from baseline to follow-up at 12 and 24 months and neurodevelopmental outcomes, with each end point adjusted for central nervous system involvement at baseline. RESULTS: A total of 96 neonates underwent randomization, of whom 86 had follow-up data at 6 months that could be evaluated. Best-ear hearing at 6 months was similar in the 6-month group and the 6-week group (2 and 3 participants, respectively, had improvement; 36 and 37 had no change; and 5 and 3 had worsening; P=0.41). Total-ear hearing (hearing in one or both ears that could be evaluated) was more likely to be improved or to remain normal at 12 months in the 6-month group than in the 6-week group (73% vs. 57%, P=0.01). The benefit in total-ear hearing was maintained at 24 months (77% vs. 64%, P=0.04). At 24 months, the 6-month group, as compared with the 6-week group, had better neurodevelopmental scores on the Bayley Scales of Infant and Toddler Development, third edition, on the language-composite component (P=0.004) and on the receptive-communication scale (P=0.003). Grade 3 or 4 neutropenia occurred in 19% of the participants during the first 6 weeks. During the next 4.5 months of the study, grade 3 or 4 neutropenia occurred in 21% of the participants in the 6-month group and in 27% of those in the 6-week group (P=0.64). CONCLUSIONS: Treating symptomatic congenital CMV disease with valganciclovir for 6 months, as compared with 6 weeks, did not improve hearing in the short term but appeared to improve hearing and developmental outcomes modestly in the longer term. (Funded by the National Institute of Allergy and Infectious Diseases; ClinicalTrials.gov number, NCT00466817.).

Complications of Treatment in Youth with HIV.

While combination antiretroviral therapy allows HIV-infected patients to have life expectancies similar to that of the general population, it may also contribute to the development of co-morbidities, such as cardiovascular disease and osteoporosis. Such complications could compromise long-term quality of life, especially in HIV-infected youth whose lifetime cumulative exposure to antiretrovirals is likely to be many decades. Recent studies continue to demonstrate abnormalities associated with antiretroviral therapy, although clinical manifestations are rare in this younger population, especially with modern antiretrovirals. The purpose of this paper is to review the most recent literature on complications of treatment in youth with HIV.

Clinical Practice Guideline by the Pediatric Infectious Diseases Society (PIDS) and the Infectious Diseases Society of America (IDSA): 2023 Guideline on Diagnosis and Management of Acute Bacterial Arthritis in Pediatrics.

This clinical practice guideline for the diagnosis and treatment of acute bacterial arthritis (ABA) in children was developed by a multidisciplinary panel representing the Pediatric Infectious Diseases Society (PIDS) and the Infectious Diseases Society of America (IDSA). This guideline is intended for use by healthcare professionals who care for children with ABA, including specialists in pediatric infectious diseases and orthopedics. The panel's recommendations for the diagnosis and treatment of ABA are based upon evidence derived from topic-specific systematic literature reviews. Summarized below are the recommendations for the diagnosis and treatment of ABA in children. The panel followed a systematic process used in the development of other IDSA and PIDS clinical practice guidelines, which included a standardized methodology for rating the certainty of the evidence and strength of recommendation using the GRADE approach (Grading of Recommendations Assessment, Development and Evaluation) (see Figure 1). A detailed description of background, methods, evidence summary and rationale that support each recommendation, and knowledge gaps can be found online in the full text.

Multisystemic therapy for poorly adherent youth with HIV: results from a pilot randomized controlled trial.

Adherence to antiretroviral medication for the treatment of HIV is a significant predictor of virologic suppression and is associated with dramatic reductions in mortality and morbidity and other improved clinical outcomes for pediatric patient populations. Effective strategies for addressing adherence problems in youth infected with HIV are needed and require significant attention to the complex interplay of multiple, interacting causal risk factors that lead to poor self-care. Within the context of a pilot randomized trial, we evaluated the feasibility and initial efficacy of a multisystemic therapy (MST) intervention adapted to address HIV medication adherence problems against a usual care condition that was bolstered with a single session of motivational interviewing (MI). For 34 participating youth, health outcomes (viral load [VL] and CD4 count) were obtained from approximately 10 months pre-baseline through approximately 6 months post-baseline and self-reported medication adherence outcomes were obtained quarterly from baseline through 9 months post-baseline. Using mixed-effects regression models we examined within- and between-groups differences in the slopes of these outcomes. Feasibility was supported, with a 77% recruitment rate and near-maximal treatment and research retention and completion rates. Initial efficacy also was supported, with the MST condition but not the MI condition demonstrating statistically and clinically significant VL reductions following the start of treatment. There was also some support for improved CD4 count and self-reported medication adherence for the MST but not the MI condition. MST was successfully adapted to improve the health outcomes of youth poorly adherent to antiretroviral medications. Replication trials and studies designed to identify the mechanisms of action are important next steps.

Clinical Practice Guideline by the Pediatric Infectious Diseases Society and the Infectious Diseases Society of America: 2021 Guideline on Diagnosis and Management of Acute Hematogenous Osteomyelitis in Pediatrics.

This clinical practice guideline for the diagnosis and treatment of acute hematogenous osteomyelitis (AHO) in children was developed by a multidisciplinary panel representing Pediatric Infectious Diseases Society (PIDS) and the Infectious Diseases Society of America (IDSA). This guideline is intended for use by healthcare professionals who care for children with AHO, including specialists in pediatric infectious diseases, orthopedics, emergency care physicians, hospitalists, and any clinicians and healthcare providers caring for these patients. The panel's recommendations for the diagnosis and treatment of AHO are based upon evidence derived from topic-specific systematic literature reviews. Summarized below are the recommendations for the diagnosis and treatment of AHO in children. The panel followed a systematic process used in the development of other IDSA and PIDS clinical practice guidelines, which included a standardized methodology for rating the certainty of the evidence and strength of recommendation using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach. A detailed description of background, methods, evidence summary and rationale that support each recommendation, and knowledge gaps can be found online in the full text.

Case study: multisystemic therapy for adolescents who engage in HIV transmission risk behaviors.

OBJECTIVE: To present a case study using multisystemic therapy (MST), an intensive family focused psychotherapy. For the clinical trial from which this case was drawn, MST was adapted to address multiple human immunodeficiency virus (HIV) transmission risk behaviors in HIV-infected youth. Targeted behaviors included medication nonadherence, risky sexual behaviors, and substance use. METHOD: One young woman's transmission risk behaviors are described, followed by a description of the MST procedures used to identify and treat the primary drivers of these risk behaviors. Outcome measures were self-report, urine screens, and blood draws. RESULTS: At discharge, the young woman showed significant improvements in medication adherence and related health status (e.g., reduced HIV viral load), healthier sexual behaviors, and reduced substance use. Importantly, neither her boyfriend nor her newborn tested positive for HIV. CONCLUSIONS: Findings from this case study suggest that MST has the potential to reduce transmission risk behaviors among teens with HIV.

Influenza vaccine: awareness and barriers to immunization in families of children with chronic medical conditions other than asthma.

OBJECTIVES: Children with chronic medical conditions (CMCs) are considered to be at increased risk for influenza and its related complications. Despite this, influenza immunization rates in the United States for children with CMCs in the primary care setting remain between 7-10%. This was a survey study looking at the barriers to influenza immunization among children with CMCs other than asthma. We examined caregiver knowledge and perceptions regarding influenza vaccine in addition to assessing other barriers, such as availability and perceived safety of the vaccine. METHODS: The study was conducted during the fall-winter influenza seasons of 2002-2003 and 2003-2004 at five academic institutions across the southeastern US. Convenience samples of 100-150 families attending pediatric subspecialty clinics were surveyed. RESULTS: A total of 794 surveys were completed. Controlling for disease, failure to recommend vaccination was significantly associated with failure to get the vaccine (P < 0.0001). Of the children who did not receive the vaccine, 61% of their parents believed that the vaccine itself could give influenza, 54% cited other safety concerns, and 30% thought it did not work. Among vaccine recipients, 163 (43%) reported that the primary care provider had given the vaccine, whereas 171 (45%) reported that the vaccine had been given at the subspecialty clinic. CONCLUSION: This study highlights the importance of physician recommendation, as well as parental education, as some of the key elements crucial to the receipt of influenza vaccination in children with CMCs.

Decision makers' perceptions of health technology decision making and priority setting at the institutional level.

This study describes health care decision makers' perceptions about decision making processes for the introduction, diffusion and prioritisation of new health technologies at the regional and institutional level. The aim of the study was to aid the design of a new process of technology assessment and decision making for the Northern Sydney and Central Coast Area Health Service (NSCCAHS). Twelve in-depth, semi-structured interviews were conducted with senior health service managers, nurse managers and senior medical clinicians in the NSCCAHS. Interviewees described prioritisation and decision-making processes as "ad hoc". Safety and effectiveness were considered the most important criteria in decision making but budgetary consideration often drove decisions about the uptake and diffusion of new technologies. Current dissatisfaction with decision-making processes creates opportunities for reform, including the introduction of consistent local technology assessments.

Acute disseminated encephalomyelitis following infectious mononucleosis.

Two months following an Epstein-Barr virus infection, a 17-year-old white female presented with seizures, intermittent visual changes, and altered mental status. Magnetic resonance imaging showed white matter changes of acute disseminated encephalomyelitis with a predilection for posterior cerebral artery distributions but without radiological evidence of arteritis. Epstein-Barr virus titers and polymerase chain reaction analysis results for the virus were consistent with postinfectious acute disseminated encephalomyelitis. The symptoms and signs improved following treatment with high-dose corticosteroids and intravenous immunoglobulin. Although Epstein-Barr virus can cause acute viral encephalomyelitis, the authors report a case of acute disseminated encephalomyelitis months after acute Epstein-Barr virus infection.

Perceptions of parents seeking an experimental herpes simplex vaccine for their adolescent and preadolescent daughters.

Perceptions of parents willing to enroll their daughters in genital herpes vaccine trials were examined by questionnaire. Respondents were knowledgeable about genital herpes and endorsed personal and societal protection as important reasons to vaccinate. A belief among some that the vaccine might promote sexual activity did not prevent them from seeking protection for their daughters.