Papers by Claudia Enriquez
Children
Data on COVID-19 convalescent plasma (CCP) safety and efficacy in children and young adults are l... more Data on COVID-19 convalescent plasma (CCP) safety and efficacy in children and young adults are limited. This single-center prospective, open-label trial evaluates CCP safety, neutralizing antibody kinetics, and outcomes in children and young adults with moderate/severe COVID-19 (April 2020–March 2021). A total of 46 subjects received CCP; 43 were included in the safety analysis (SAS); 7.0% < 2 years old, 2.3% 2–<6, 27.9% 6–<12, 39.5% 12–<19, and 23.3% > 19 years old; 28 were included in the antibody kinetic analysis (AbKS); 10.7% < 2 years old, 10.7% 6–<12, 53.8% 12–<19, and 25.0% > 19 years old. No adverse events occurred. The median COVID-19 severity score improved (5.0 pre-CCP to 1.0 by day 7; p < 0.001). A rapid increase in the median percentage of inhibition was observed in AbKS (22.5% (13.0%, 41.5%) pre-infusion to 52% (23.7%, 72%) 24 h post-infusion); a similar increase was observed in nine immune-competent subjects (28% (23%, 35%) to 63% (53%, ...
Open Forum Infectious Diseases, 2021
BackgroundPediatric central nervous system (CNS) infections are potentially life-threatening and ... more BackgroundPediatric central nervous system (CNS) infections are potentially life-threatening and may incur significant morbidity. Identifying a pathogen is important, both in terms of guiding therapeutic management and in characterizing prognosis. Usual care testing by culture and polymerase chain reaction is often unable to identify a pathogen. We examined the systematic application of metagenomic next-generation sequencing (mNGS) for detecting organisms and transcriptomic analysis of cerebrospinal fluid (CSF) in children with central nervous system (CNS) infections.MethodsWe conducted a prospective multisite study that aimed to enroll all children with a CSF pleocytosis and suspected CNS infection admitted to 1 of 3 tertiary pediatric hospitals during the study timeframe. After usual care testing had been performed, the remaining CSF was sent for mNGS and transcriptomic analysis.ResultsWe screened 221 and enrolled 70 subjects over a 12-month recruitment period. A putative organism...
Journal of the Pediatric Infectious Diseases Society, 2021
Introduction A novel Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified ... more Introduction A novel Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified as the pathogen responsible for a serious, life threatening respiratory infection (COVID-19) initially reported in Wuhan, China which rapidly spread worldwide resulting in global pandemic. Multiple immunological and pharmacological therapies have been evaluated with variable results. Convalescent plasma has been used in previous outbreaks such as Influenza 1918 and 2009, Ebola, MERS and SARS with good efficacy and safety reported. There have been multiple large reports on the safety of COVID-19 convalescent plasma (CCP) for the treatment of this serious infection in the adults; controversy has ensued regarding its efficacy. Pediatric data on CCP use are limited. Methods We conducted a prospective, open label treatment trial using CCP (10 ml/kg up to 1 unit) for the treatment of COVID-19 in pediatric patients with moderate to severe disease or high risk for serious illness. Safety and ant...
Pediatric Infectious Disease Journal, 2021
BACKGROUND Therapies against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) and its... more BACKGROUND Therapies against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) and its life-threatening respiratory infection coronavirus disease 2019 (COVID-19) have been evaluated, including COVID-19 convalescent plasma (CCP). Multiple large reports of CCP treatment in adults exist. Pediatric data on CCP safety and efficacy are limited. METHODS Single-center prospective, open-label trial looking at safety, antibody kinetics and outcomes of CCP (10 mL/kg, max 1 unit) treatment for COVID-19 in hospitalized pediatric patients with moderate to severe disease or at high risk for serious illness. RESULTS Thirteen patients were enrolled. No infusion-related adverse events occurred. No hematological or metabolic adverse events were noted during hospitalization or at 3-weeks. Ten patients had clinical improvement by day 7 (WHO eight-category ordinal severity scale for COVID-19). Following CCP, anti-SARS-CoV-2 anti-nucleocapsid IgG increased significantly at 24 hours and high levels were sustained at 7- and 21-days. Transient IgM response was noted. Twelve patients (92.3%) were discharged home, 9 (75%) by day 7 post-CCP. One remained on invasive ventilatory support 42 days after CCP and was eventually discharged to an intermediate care facility. The single patient death was retrospectively confirmed to have had brain death before CCP. CONCLUSION CCP was well tolerated in pediatric patients, resulted in rapid antibody increase, and did not appear to interfere with immune responses measured at 21 days. More pediatric data are necessary to establish the efficacy of CCP, but our data suggest benefit in moderate to severe COVID-19 when used early. Other immunological or antiviral interventions may be added as supported by emerging data.
Open Forum Infectious Diseases, 2020
Background Pediatric central nervous system (CNS) infections are potentially life-threatening and... more Background Pediatric central nervous system (CNS) infections are potentially life-threatening and may incur significant morbidity. Identifying a pathogen is important, both in terms of guiding therapeutic management, but also in characterizing prognosis. However, standard care testing by culture, serology, and PCR is often unable to identify a pathogen. We examined use of next generation sequencing (NGS) of cerebrospinal fluid (CSF) in detecting an organism in children with CNS infections. Methods We prospectively enrolled children with CSF pleocytosis and suspected CNS infection admitted to 3 tertiary pediatric hospitals. After standard care testing had been performed, the remaining CSF was submitted for analysis by NGS. Results We enrolled 70 subjects over a 12-month recruitment period. A putative organism was isolated from CSF in 24 (34.3%) subjects by any diagnostic modality. NGS of the CSF samples identified a pathogen in 20 (28.6%) subjects. False positive results by NGS were ...
Background: The assembly of the intestinal microbiota of extremely low birthweight (ELBW) infants... more Background: The assembly of the intestinal microbiota of extremely low birthweight (ELBW) infants has an important impact on both immediate and long term health. ELBW infants are frequently given antibiotics which are likely to perturb the assembly of the microbiota. Health complications are not uncommon for ELBW infants; they face health crises including sepsis and necrotizing enterocolitis (NEC). Microbes are thought to be involved in the pathogenesis of NEC, but the mechanisms are unclear. New understanding of the importance of human milk oligosaccharides and the establishment of a Bifidobacteria -dominated gut microbiota early in infancy suggest that all preterm infants have abnormal microbial colonization. The initial assembly of intestinal microbial communities may have significant impact on immune development and lifelong health. Results: We measured the bacterial composition and metabolite profile of 32 ELBW infants by 16S rRNA gene sequencing and untargeted gas chromatograp...
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Papers by Claudia Enriquez