scholarly journals Comparison of Intravenous Palivizumab and Standard of Care for Treatment of Respiratory Syncytial Virus Infection in Mechanically Ventilated Pediatric Patients

2016 ◽  
Vol 21 (2) ◽  
pp. 146-154 ◽  
Author(s):  
Brady J. Helmink ◽  
Carolyn E. Ragsdale ◽  
Evan J. Peterson ◽  
Kathryn G. Merkel

OBJECTIVES: Evidence suggests palivizumab may be beneficial for respiratory syncytial virus (RSV) infection in pediatric patients, although it is only approved by the US Food and Drug Administration for RSV prophylaxis. The objective of this study is to compare outcomes among pediatric patients with RSV infection who received intravenous palivizumab and standard of care versus standard of care alone. METHODS: This is a retrospective, single-center cohort study conducted between November 2003 and October 2013. Pediatric patients with active RSV infection treated with intravenous (IV) palivizumab after initiation of mechanical ventilation were matched 1:1 to a control selected from ventilated patients who received standard of care. The primary end point evaluated the duration of mechanical ventilation between groups. Secondary end points included hospital length of stay, intensive care unit length of stay, duration of respiratory support over baseline, time to RSV microbiologic cure, duration of antibiotic therapy, and in-hospital mortality. RESULTS: A total of 22 patients with a median age of 3 months were included in the study. Patients in the treatment group received a median of 2 doses of IV palivizumab, with a mean dose of 14.2 mg/kg. All patients received bronchodilators and corticosteroids, with the exception of 1 patient in the control group, and only 1 treatment group patient received IV ribavirin. Duration of mechanical ventilation was longer in the treatment group (18.9 ± 9.5 vs. 14.3 ± 9.3 days; p = 0.26). No statistically significant differences were observed between groups for any of the secondary end points. CONCLUSIONS: Pediatric patients who received IV palivizumab in addition to standard of care for treatment of RSV infection following initiation of mechanical ventilation experienced similar outcomes to those who received standard of care alone. Further studies are necessary to evaluate the potential benefit of IV palivizumab in addition to current standard of care.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 5267-5267
Author(s):  
Sema S. Anak ◽  
Didem Atay ◽  
Mesut Garipardic ◽  
Beril Ozalp ◽  
Diana Yani ◽  
...  

Abstract Respiratory syncytial virus (RSV) has been reported to cause severe morbidity and mortality among cancer patients receiving chemotherapy together with or without autologous/allogeneic stem cell transplantation (APBSCT), but there have been few reports describing the outcome of RSV infection specifically among pediatric oncology patients. Between February 20 – April 15, 2006, among 15 pediatric patients hospitalized for various oncologic diseases and post-BMT problems, 7 patients developed progressive cough and/or dyspnea. A survey of respiratory viruses was done using direct immunofluorescent antibody assay. Three patients (two high-risk patients with acute lymphoblastic leukemia receiving induction or consolidation chemotherapy, one under treatment for chronic GvHD postBMT) were found positive for RSV (20%). The remaining patients with respiratory symptoms were followed-up for RSV infection, but remained negative during all surveys. Three patients and the sister of the boy with hyper-IgM syndrome, who was also transplanted for hyper-IgM syndrome and under treatment for chronic GvHD and pneumonia, in the same room with her brother, were all treated with IVIG and specific antiviral therapy, oral Ribavirin (20–25 mg/kg/day in three doses). All patients recovered fully, although two were retreated due to recurrent RSV positivity and respiratory symptoms within two weeks. In striking contrast with the outcome of RSV infection in adult oncology patients, the mortality associated with RSV infection in pediatric oncology patients even in postBMT period, is very low and can easily be treated with IVIG and oral Ribavirin, used effectively because of unavailability of other forms (iv or nebulized forms) in our country, if diagnosed and treated early enough. It is even possible to give the scheduled anti-neoplastic therapy for not being delayed.


2020 ◽  
Author(s):  
Svetlana Rezinciuc ◽  
Lavanya Bezavada ◽  
Azadeh Bahadoran ◽  
Jesse F. Ingels ◽  
Young-Yin Kim ◽  
...  

AbstractTo determine whether respiratory syncytial virus (RSV) regulates human metabolism, we used positron emission tomography (PET) of patient lungs along with bioenergetics and metabolomics of patient upper airway cells and fluids. We previously found a significant negative monotonic relationship between glucose uptake and respiratory viral infection in 20 pediatric patients (e.g., 70% of infected patients had glucose uptake within 0–3 days). In our recent study, 3 out of 4 patients positive for glucose uptake at later times (>5 days) were positive for RSV infection. At present, the bioenergetics of upper respiratory cells (URCs) from nasal pharyngeal aspirates have not been investigated, and in vitro studies indicate RSV reduces metabolism in cell lines. To define metabolic changes in RSV-infected pediatric patients, we acquired fresh aspirates from 6 pediatric patients. Immediately following aspiration of URCs, we measured the two major energy pathways using an XFe flux analyzer. Glycolysis and mitochondrial respiration were significantly increased in URCs from RSV-infected patients, and mitochondrial respiration was operating at near maximal levels, resulting in loss of cellular capacity to increase respiration with impaired coupling efficiency. Metabolomics analysis of metabolites flushed from the upper airways confirmed a significant increase in TCA cycle intermediates. Taken together, these studies demonstrate RSV induces significant hypermetabolism in pediatric patients’ lungs and respiratory tract. Thus, hypermetabolism is a potential anti-viral drug target and reveals RSV can regulate human metabolism.Contributions to the fieldMetabolic changes in humans in response to viral infection are largely unknown. In this brief clinical report, we find metabolism is markedly increased in live upper respiratory cells from infants infected with respiratory syncytial virus (RSV) concomitant to changes in metabolites in their upper airway fluids. This sheds light on viral induced hypermetabolism in the airways and offers potential biomarkers for RSV. In addition, this identifies potential therapeutic targets for host directed therapies of aberrant metabolism in RSV. This work has clinical impact as biomarkers and therapeutics for RSV are needed for this pervasive virus that causes infections with long term consequence for some children. Further, advancements in molecular mechanisms underpinning RSV infection biology are constrained by the difficulties in translating model systems to humans as well as relating human studies in adults to infants (Mestas and Hughes, 2004; Papin et al., 2013).


2016 ◽  
Vol 27 (1) ◽  
pp. 16-25 ◽  
Author(s):  
Patricia Y. Chu ◽  
Christoph P. Hornik ◽  
Jennifer S. Li ◽  
Michael J. Campbell ◽  
Kevin D. Hill

AbstractObjectiveThe aim of the study was to evaluate the trends in respiratory syncytial virus-related hospitalisations and associated outcomes in children with haemodynamically significant heart disease in the United States of America.Study designThe Kids’ Inpatient Databases (1997–2012) were used to estimate the incidence of respiratory syncytial virus hospitalisation among children ⩽24 months with or without haemodynamically significant heart disease. Weighted multivariable logistic regression and chi-square tests were used to evaluate the trends over time and factors associated with hospitalisation, comparing eras before and after publication of the 2003 American Academy of Pediatrics palivizumab immunoprophylaxis guidelines. Secondary outcomes included in-hospital mortality, morbidity, length of stay, and cost.ResultsOverall, 549,265 respiratory syncytial virus-related hospitalisations were evaluated, including 2518 (0.5%) in children with haemodynamically significant heart disease. The incidence of respiratory syncytial virus hospitalisation in children with haemodynamically significant heart disease decreased by 36% when comparing pre- and post-palivizumab guideline eras versus an 8% decline in children without haemodynamically significant heart disease (p<0.001). Children with haemodynamically significant heart disease had higher rates of respiratory syncytial virus-associated mortality (4.9 versus 0.1%, p<0.001) and morbidity (31.5 versus 3.5%, p<0.001) and longer hospital length of stay (17.9 versus 3.9 days, p<0.001) compared with children without haemodynamically significant heart disease. The mean cost of respiratory syncytial virus hospitalisation in 2009 was $58,166 (95% CI:$46,017, $70,315).ConclusionsThese data provide stakeholders with a means to evaluate the cost–utility of various immunoprophylaxis strategies.


PEDIATRICS ◽  
1994 ◽  
Vol 93 (5) ◽  
pp. 872-873
Author(s):  
Aaron R. Zucker

I am the Director of Pediatric Critical Care at Wyler Children's Hospital at the University of Chicago. Because I had personally witnessed problems when administering ribavirin for respiratory syncytial virus (RSV) lung disease, I became interested in learning about others' experiences with the drug. At that time, no studies particular to the drug's use in mechanically ventilated infants had been published, yet the 1991 Red Book stated that "infants who require mechanical ventilation because of severe RSV infection are those who may be most likely to benefit from ribavirin treatment."


2021 ◽  
pp. 003335492110415
Author(s):  
Connor R. Goldman ◽  
William D. Sieling ◽  
Luis R. Alba ◽  
Raul A. Silverio Francisco ◽  
Celibell Y. Vargas ◽  
...  

Objectives Respiratory syncytial virus (RSV) causes substantial morbidity and mortality in older adults. We assessed severe clinical outcomes among hospitalized adults that were associated with RSV infections. Methods We performed a nested retrospective study in 3 New York City hospitals during 2 respiratory viral seasons, October 2017–April 2018 and October 2018–April 2019, to determine the proportion of patients with laboratory-confirmed RSV infection who experienced severe outcomes defined as intensive care unit (ICU) admission, mechanical ventilation, and/or death. We assessed factors associated with these severe outcomes and explored the effect of RSV-associated hospitalizations on changes in the living situations of surviving patients. Results Of the 403 patients studied (median age, 69 years), 119 (29.5%) were aged ≥80. Severe outcomes occurred in 19.1% of patients, including ICU admissions (16.4%), mechanical ventilation (12.4%), and/or death (6.7%). Patients admitted from residential living facilities had a 4.43 times higher likelihood of severe RSV infection compared with patients who were living in the community with or without assistance from family or home health aides. At discharge, 56 (15.1%) patients required a higher level of care than at admission. Conclusions RSV infection was associated with severe outcomes in adults. Living in a residential facility at admission was a risk factor for severe outcomes and could be a proxy for frailty rather than an independent risk factor. Our data support the development of prevention strategies for RSV infection in older populations, especially older adults living in residential living facilities.


2021 ◽  
Vol 47 (09) ◽  
pp. 381-396
Author(s):  
Aireen Wingert ◽  
Jennifer Pillay ◽  
Dorothy L Moore ◽  
Ben Vandermeer ◽  
Michele P Dyson ◽  
...  

Respiratory syncytial virus (RSV) infections are common among young children and represent a significant burden to patients, their families and the Canadian health system. Here we conduct a rapid review of the burden of RSV illness in children 24 months of age or younger. Four databases (Medline, Embase, Cochrane Database of Clinical Trials, ClinicalTrials.gov from 2014 to 2018), grey literature and reference lists were reviewed for studies on the following: children with or without a risk factor, without prophylaxis and with lab-confirmed RSV infection. Of 29 studies identified, 10 provided within-study comparisons and few examined clinical conditions besides prematurity. For infants of 33–36 weeks gestation (wGA) versus term infants, there was low-to-moderate certainty evidence for an increase in RSV-hospitalizations (n=599,535 infants; RR 2.05 [95% CI 1.89–2.22]; 1.3 more per 100 [1.1–1.5 more]) and hospital length of stay (n=7,597 infants; mean difference 1.00 day [95% CI 0.88–1.12]). There was low-to-moderate certainty evidence of little-to-no difference for infants born at 29–32 versus 33–36 wGA for hospitalization (n=12,812 infants; RR 1.20 [95% CI 0.92–1.56]). There was low certainty evidence of increased mechanical ventilation for hospitalized infants born at 29–32 versus 33–35 wGA (n=212 infants; RR 1.58, 95% CI 0.94–2.65). Among infants born at 32–35 wGA, hospitalization for RSV in infancy may be associated with increased wheeze and asthma-medication use across six-year follow-up (RR range 1.3–1.7). Children with versus without Down syndrome may have increased hospital length of stay (n=7,206 children; mean difference 3.00 days, 95% CI 1.95–4.05; low certainty). Evidence for other within-study comparisons was of very low certainty. In summary, prematurity is associated with greater risk for RSV-hospitalization and longer hospital length of stay, and Down syndrome may be associated with longer hospital stay for RSV. Respiratory syncytial virus-hospitalization in infancy may be associated with greater wheeze and asthma-medication use in early childhood. Lack of a comparison group was a major limitation for many studies.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Masaaki Mori ◽  
Shinichi Watabe ◽  
Tomoaki Taguchi ◽  
Hisaya Hasegawa ◽  
Mika Ishige ◽  
...  

Abstract Background The prophylactic use of anti-respiratory syncytial virus (RSV) antibody (palivizumab) for severe RSV infection is not approved in Japan in specified groups of infants with neuromuscular diseases or other rare diseases associated with reduced ventilation competence or difficulty in expectoration, which increase the risk of exacerbation of severe RSV infection. The objective of this study is to investigate the efficacy, safety, and pharmacokinetics of palivizumab in pediatric patients with those rare diseases for which palivizumab is not indicated at present. Methods/design This study is a multicenter, uncontrolled, open-label study planned to be carried out between July 1, 2019 and June 30, 2022 at 7 medical institutions in Japan. The study population will be recruited from among neonates, infants, or children aged 24 months or younger with a condition falling under any of the following 5 disease groups: pulmonary hypoplasia, airway stenosis, congenital esophageal atresia, inherited metabolic disease, or neuromuscular disease. The planned sample size is 18 subjects, including at least 3 subjects per disease group. Throughout the RSV season, at least 4 continuous doses of palivizumab will be administered intramuscularly at 15 mg/kg at intervals of 30 days. The efficacy and safety of palivizumab will be comprehensively evaluated based on the incidence of RSV-related hospitalization, and serum palivizumab concentration, serum anti-palivizumab antibody concentration, and the occurrence of adverse events/reactions after the start of palivizumab treatment. Discussion This study will evaluate the efficacy and safety of palivizumab in pediatric patients with rare diseases which place them at high risk of severe RSV infection, but which fall outside the current indications for palivizumab prophylaxis. The generated data will have implications for the regulatory approval of prophylactic palivizumab treatment in this patient group. Trial registration This study has been prospectively registered in Japic Clinical Trials Information, which is managed and administered by the Japan Pharmaceutical Information Center (registration number: JapicCTI-194946, registration date: September 10, 2019).


Sign in / Sign up

Export Citation Format

Share Document