Dataset Information

Serious Adverse Events in the Canadian Registry of Children Receiving Palivizumab (CARESS) for Respiratory Syncytial Virus Prevention.

ABSTRACT: To evaluate the safety and tolerability of palivizumab for RSV prophylaxis in high-risk children in everyday practice.High-risk children prophylaxed against RSV infection were recruited into a prospective, observational, Canadian RSV Evaluation Study of Palivizumab (CARESS) registry with active, serious adverse event (SAE) monitoring from 2008 to 2013. SAE reports were systematically collected and assessed for severity and relationship to palivizumab. Data were analyzed by Chi-square or Fisher Exact Tests to examine group differences in proportions.13025 infants received 57392 injections. Hospitalizations for respiratory-related illness (RIH) were reported in 915 patients, and SAEs other than RIH were reported in 52 patients. Of these, 6 (0.05%) patients had a total of 14 hypersensitivity reactions that were deemed possibly or probably related to palivizumab (incidence: 2.8 per 10,000 patient-months). The SAEs of 42 patients were assessed as not related to palivizumab. SAEs in the remaining 4 patients were not classifiable as their records were incomplete. There were no significant demographic predictors of SAE occurrence.Under active surveillance, a small proportion of infants in the CARESS registry experienced SAEs that had a potential relationship with palivizumab and these appeared to be unpredictable in terms of onset. Palivizumab appears to be a safe and well-tolerated antibody for RSV prophylaxis in high-risk children in routine practice.

SUBMITTER: Chen JJ

PROVIDER: S-EPMC4523213 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Serious Adverse Events in the Canadian Registry of Children Receiving Palivizumab (CARESS) for Respiratory Syncytial Virus Prevention.

Chen Jinghan Jenny JJ Chan Parco P Paes Bosco B Mitchell Ian I Li Abby A Lanctôt Krista L KL

PloS one 20150803 8

<h4>Objectives</h4>To evaluate the safety and tolerability of palivizumab for RSV prophylaxis in high-risk children in everyday practice.<h4>Methods</h4>High-risk children prophylaxed against RSV infection were recruited into a prospective, observational, Canadian RSV Evaluation Study of Palivizumab (CARESS) registry with active, serious adverse event (SAE) monitoring from 2008 to 2013. SAE reports were systematically collected and assessed for severity and relationship to palivizumab. Data were ...[more]

PMID: 26237402

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Project description:Abstract Background Palivizumabis a monoclonal antibody for preventionof serious lower respiratory tract infection caused by respiratory syncytial virus (RSV) in high risk children. Safety and efficacy were established in infants with bronchopulmonary dysplasia (BPD), prematurity (≤ 35 weeks gestational age), and hemodynamically significant congenital heart disease (CHD). The Canadian Registry of Palivizumab (CARESS) tracks palivizumab utilization in high-risk infants, whatever the indication. The decision to give palivizumab is by individual clinicians, not by the investigators, and is often for conditions not listed in the product monograph. Objectives To describe changes over time in indications for palivizumab prophylaxis in Canadian children using a Registry Database. Design/Methods A prospective, observational registry of infants from 32 sites who received ≥1 dose of palivizumab during the 2005–2016 RSV seasons. Usage by indications is shown in two-year increments (Table 1), omitting 2016–17 when enrollment was limited; focused on those with complex medical disorders (CMD).Year*BPDPrematureCHDCMDTotaln%n%n%n%n2005–0716910.6117874.41499.4885.615842007–093449.3256069.33599.743411.736972009–114548.8326663.254010.590617.551662011–134888.3357261.171012.1107318.458432013–154528.8288656.164212.5116622.651472015–161717.9130360.321810.146921.72161Total20788.81476562.6261811.1413617.523598 *year defined as beginning of RSV season in one year to beginning of RSV season in the next year Results 23,598 infants were enrolled, the overall indications for palivizumab were prematurity (62.6%), BPD (8.8%), CHD (11.1%), CMD (17.5%). Comparing groups across the 11 RSV seasons, the percentage with BPD was10.6–8.8%; prematurity decreased from 74.4% to 60.3% and CHD peaked at 12.5% from 2013–15. Palivizumab use in the CMD group rose from 5.6% to 22.6% (2013–15). Total n (%) with specific diagnoses were: Trisomy 21; 942 (21.2), Congenital airway anomalies; 855 (19.2), Neurological disorders; 471 (10.6), Cystic fibrosis; 442 (9.9) other pulmonary; 438 (9.8). The remainder comprised children with multiple indications, or individually less common diseases. Conclusion Caution is required in interpreting these data from a voluntary registry. Nevertheless the off label use of palivizumab in CMD has increased substantially. We suspect this reflects a desire of individual clinicians to protect “fragile” children whenever possible. Clinical Trial Registration: ClinicalTrials.gov NCT00420966

Project description:Abstract Background The Canadian Registry of Palivizumab (CARESS) tracks palivizumab utilization and hospitalizations for respiratory illness (RI) and respiratory syncytial virus (RSVH) in high-risk infants, whatever the indication. The decision to administer palivizumab is taken by individual clinicians at the participating centers. Objectives To provide insight into the current management (utilization, adherence) with palivizumab of children at high risk of RSV infection in the tertiary care centers and community settings through the development of a Canadian Registry Database. A registry may give some indication of safety and effectiveness of an intervention in real life situations in many, uncommon medical conditions. Design/Methods A prospective, observational registry of infants from 32 sites who received ≥1 dose of palivizumab during the 2005–2017 RSV seasons. Palivizumab utilization and RI outcomes were collected monthly over each individual season. Results 25,003 infants were enrolled, the majority were male (56.3%) and Caucasian (68.6%). Subjects were, on average, 5.7 ± 6.4 months old at the time of enrolment, and had a mean gestational age of 32.6 ± 5.0 weeks. Of the children enrolled, indications for palivizumab were prematurity (≤ 35 weeks gestation, 63.3%), chronic lung disease (8.4%), significant congenital heart disease (10.5%), and other complex medical illnesses (17.8%). A total of 109,579 injections were given; average of 4 ± 1 injections per infant. Serious adverse events were uncommon. Adherence was measured in two ways. The number of actual injections compared with the expected and by this measure 83.8% received all of the expected injections. Adherence was also measured based on the length of the inter-injection interval, and by this measure 74.8% were adherent. Over the 12 seasons of CARESS, 1724 children were hospitalized a total of 2054 times. The overall RIH rate was 6.9%, the lowest being in preterm infants (4.3%). 1474 of 1724 children were tested for RSV;334 were RSV-positive. The cumulative RSVH rate was 1.6%. Conclusion The most common indications for palivizumab are prematurity, followed by those with medical complexity. Palivizumab is safe, and given that all of the infants are at high-risk for RSV, an adherence of 74.8% is not unreasonable. The low RSVH (1.6%) rate indicates that palivizumab is effective in the populations in which it is administered. Clinical Trial Registration: ClinicalTrials.gov NCT00420966

Project description:BackgroundLimited data are available on adverse events among children admitted to hospital. The Canadian Paediatric Adverse Events Study was done to describe the epidemiology of adverse events among children in hospital in Canada.MethodsWe performed a 2-stage medical record review at 8 academic pediatric centres and 14 community hospitals in Canada. We reviewed charts from patients admitted from April 2008 through March 2009, evenly distributed across 4 age groups (0 to 28 d; 29 to 365 d; > 1 to 5 yr and > 5 to 18 yr). In stage 1, nurses and health records personnel who had received training in the use of the Canadian Paediatric Trigger Tool reviewed medical records to detect triggers for possible adverse events. In stage 2, physicians reviewed the charts identified as having triggers and described the adverse events.ResultsA total of 3669 children were admitted to hospital during the study period. The weighted rate of adverse events was 9.2%. Adverse events were more frequent in academic pediatric centres than in community hospitals (adjusted odds ratio [OR] 2.98, 95% confidence interval [CI] 1.65-5.39). The incidence of preventable adverse events was not significantly different between types of hospital, but nonpreventable adverse events were more common in academic pediatric centres (adjusted OR 4.39, 95% CI 2.08-9.27). Surgical events predominated overall and occurred more frequently in academic pediatric centres than in community hospitals (37.2% v. 21.5%, relative risk [RR] 1.7, 95% CI 1.0-3.1), whereas events associated with diagnostic errors were significantly less frequent (11.1% v. 23.1%, RR 0.5, 95% CI 0.2-0.9).InterpretationMore children have adverse events in academic pediatric centres than in community hospitals; however, adverse events in the former are less likely to be preventable. There are many opportunities to reduce harm affecting children in hospital in Canada, particularly related to surgery, intensive care and diagnostic error.

Dataset Information

Serious Adverse Events in the Canadian Registry of Children Receiving Palivizumab (CARESS) for Respiratory Syncytial Virus Prevention.

Publications

Serious Adverse Events in the Canadian Registry of Children Receiving Palivizumab (CARESS) for Respiratory Syncytial Virus Prevention.

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