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  1. Article ; Online: Multiple Polymerase Chain Reaction for Direct Detection of Bloodstream Infection After Cardiac Surgery in a PICU.

    Checa, Rosa María Calderón / Gijón, Manuel / Hofheinz, Sylvia Belda / Rojo, Pablo

    Critical care explorations

    2022  Volume 4, Issue 6, Page(s) e0707

    Abstract: Nosocomial infections are a prevalent cause of death and complications in critically ill children. Conventional cultures are able to detect only up to 25% of bacteremia. Several studies have suggested that molecular tests could be a faster and effective ... ...

    Abstract Nosocomial infections are a prevalent cause of death and complications in critically ill children. Conventional cultures are able to detect only up to 25% of bacteremia. Several studies have suggested that molecular tests could be a faster and effective tool for detection of bacterial infections. The objective of this study is to compare molecular tests for bacterial detection in whole blood samples, with routine blood culture for the diagnosis of nosocomial bloodstream infections (BSIs).
    Design: Prospective cohort study.
    Setting: A PICU of a tertiary center, reference for congenital heart diseases.
    Patients: Children, 0-16 years, admitted to PICU between August 2016 and December 2019 after cardiac surgery were prospectively recruited. Demographic, clinical, laboratory, and microbiologic data from patient's medical records, and laboratory and microbiologic results were collected.
    Interventions: In all patients, blood culture and multiple polymerase chain reaction (PCR) for bacterial detection in a whole blood sample were performed.
    Measurements and main results: Fifty-seven cases (patients with suspected infection) and 36 controls (patients with no suspected infection) were recruited during this period; 51.6% were female. Median age was 6 months (interquartile range [IQR], 0-13 mo), and median weight was 5 kg (IQR, 3.5-9.5 kg).From the cases, 33% (19/57) had a confirmed BSI with positive blood culture; 52% were Gram-negative bacilli, and 48% were Gram-positive cocci. Thirty-three percentage (19/57) had a positive PCR with only a 26% (five cases) of concordance between PCR result and blood culture (three bacteremias for
    Conclusions: Multiple PCRs in whole blood samples did not appear to be more sensitive than blood cultures in this series. Better concordance was found with Gram-negative microorganisms.
    Language English
    Publishing date 2022-05-27
    Publishing country United States
    Document type Journal Article
    ISSN 2639-8028
    ISSN (online) 2639-8028
    DOI 10.1097/CCE.0000000000000707
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: CROCuS, a Phase II Study Evaluating the Antiviral Activity, Clinical Outcomes, and Safety of Rilematovir in Children Aged ≥ 28 Days and ≤ 3 Years with Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus.

    Ferrero, Fernando / Lin, Chien-Yu / Liese, Johannes / Luz, Kleber / Stoeva, Tatyana / Nemeth, Agnes / Gijón, Manuel / Calvo, Cristina / Natalini, Silvina / Toh, Teck-Hock / Deleu, Sofie / Chen, Bohang / Rusch, Sarah / Sánchez, Beatriz López / Leipoldt, Illse / Vijgen, Leen / Huntjens, Dymphy / Baguet, Tristan / Bertzos, Kristi /
    Gamil, Mohamed / Stevens, Marita

    Paediatric drugs

    2024  

    Abstract: Background: Respiratory syncytial virus (RSV) causes significant morbidity and mortality in children aged ≤ 5 years and adults aged ≥ 60 years worldwide. Despite this, RSV-specific therapeutic options are limited. Rilematovir is an investigational, ... ...

    Abstract Background: Respiratory syncytial virus (RSV) causes significant morbidity and mortality in children aged ≤ 5 years and adults aged ≥ 60 years worldwide. Despite this, RSV-specific therapeutic options are limited. Rilematovir is an investigational, orally administered inhibitor of RSV fusion protein-mediated viral entry.
    Objective: To establish the antiviral activity, clinical outcomes, safety, and tolerability of rilematovir (low or high dose) in children aged ≥ 28 days and ≤ 3 years with RSV disease.
    Methods: CROCuS was a multicenter, international, double-blind, placebo-controlled, randomized, adaptive phase II study, wherein children aged ≥ 28 days and ≤ 3 years with confirmed RSV infection who were either hospitalized (Cohort 1) or treated as outpatients (Cohort 2) were randomized (1:1:1) to receive rilematovir (low or high dose) or placebo. Study treatment was administered daily as an oral suspension from days 1 to 7, with dosing based on weight and age groups. The primary objective was to establish antiviral activity of rilematovir by evaluating the area under the plasma concentration-time curve of RSV viral load in nasal secretions from baseline through day 5. Severity and duration of RSV signs and symptoms and the safety and tolerability of rilematovir were also assessed through day 28 (± 3).
    Results: In total, 246 patients were randomized, treated, and included in the safety analysis population (Cohort 1: 147; Cohort 2: 99). Of these, 231 were included in the intent-to-treat-infected analysis population (Cohort 1: 138; Cohort 2: 93). In both cohorts, demographics were generally similar across treatment groups. In both cohorts combined, the difference (95% confidence interval) in the mean area under the plasma concentration-time curve of RSV RNA viral load through day 5 was - 1.25 (- 2.672, 0.164) and - 1.23 (- 2.679, 0.227) log
    Conclusions: Data from the combined cohort suggest that rilematovir has a small but favorable antiviral effect of indeterminate clinical relevance compared with placebo, as well as a favorable safety profile. Safe and effective therapeutic options for RSV in infants and young children remain an unmet need.
    Clinical trial registration: EudraCT Number: 2016-003642-93; ClinicalTrials.gov Identifier: NCT03656510. First posted date: 4 September, 2018.
    Language English
    Publishing date 2024-04-22
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 1492748-2
    ISSN 1179-2019 ; 1174-5878
    ISSN (online) 1179-2019
    ISSN 1174-5878
    DOI 10.1007/s40272-024-00625-x
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Pediatric Community-Acquired Bone and Joint Staphylococcus Aureus Infections In Europe: Severe Infections are Associated to Panton-Valentine Leucocidin Presence.

    Gijón, Manuel / Bellusci, Marcello / Petraitiene, Birute / Noguera-Julian, Antoni / Glikman, Daniel / Saavedra-Lozano, Jesús / Neth, Olaf / Daskalaki, Maria / Zilinskaite, Virginija / Kaiser-Labusch, Petra / Prieto, Luis / Rojo, Pablo

    The Pediatric infectious disease journal

    2020  Volume 39, Issue 6, Page(s) e73–e76

    Abstract: To analyze host and pathogen factors related to disease severity of community-acquired bone and joint infections in children, a cohort of pediatric patients was prospectively recruited from 13 centers in 7 European countries. A total of 85 children were ... ...

    Abstract To analyze host and pathogen factors related to disease severity of community-acquired bone and joint infections in children, a cohort of pediatric patients was prospectively recruited from 13 centers in 7 European countries. A total of 85 children were included, 11 (13%) had a severe infection. Panton-Valentine leukocidin-positive isolates were 17%, and 6% of the isolates were methicillin-resistant Staphylococcus aureus. Multivariate analysis identified Panton-Valentine leukocidin presence (adjusted odds ratio, 12.6; P = 0.01) as the only factor independently associated with severe outcome, regardless of methicillin resistance.
    MeSH term(s) Adolescent ; Arthritis, Infectious/epidemiology ; Arthritis, Infectious/microbiology ; Bacterial Toxins/genetics ; Bone and Bones/microbiology ; Child ; Child, Preschool ; Community-Acquired Infections/epidemiology ; Community-Acquired Infections/microbiology ; Europe/epidemiology ; Exotoxins/genetics ; Humans ; Infant ; Infant, Newborn ; Joints/microbiology ; Leukocidins/genetics ; Methicillin-Resistant Staphylococcus aureus/pathogenicity ; Prospective Studies ; Severity of Illness Index ; Staphylococcal Infections/epidemiology ; Staphylococcal Infections/transmission ; Staphylococcus aureus/genetics ; Staphylococcus aureus/pathogenicity ; Virulence Factors
    Chemical Substances Bacterial Toxins ; Exotoxins ; Leukocidins ; Panton-Valentine leukocidin ; Virulence Factors
    Language English
    Publishing date 2020-03-28
    Publishing country United States
    Document type Journal Article ; Multicenter Study
    ZDB-ID 392481-6
    ISSN 1532-0987 ; 0891-3668
    ISSN (online) 1532-0987
    ISSN 0891-3668
    DOI 10.1097/INF.0000000000002640
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Diagnostic Accuracy of the Panbio Severe Acute Respiratory Syndrome Coronavirus 2 Antigen Rapid Test Compared with Reverse-Transcriptase Polymerase Chain Reaction Testing of Nasopharyngeal Samples in the Pediatric Population.

    Villaverde, Serena / Domínguez-Rodríguez, Sara / Sabrido, Gema / Pérez-Jorge, Conchita / Plata, Marta / Romero, María Pilar / Grasa, Carlos Daniel / Jiménez, Ana Belén / Heras, Elena / Broncano, Antonio / Núñez, María Del Mar / Illán, Marta / Merino, Paloma / Soto, Beatriz / Molina-Arana, David / Bermejo, Amanda / Mendoza, Pablo / Gijón, Manuel / Pérez-Moneo, Begoña /
    Moraleda, Cinta / Tagarro, Alfredo

    The Journal of pediatrics

    2021  Volume 232, Page(s) 287–289.e4

    Abstract: We conducted a multicenter clinical validity study of the Panbio coronavirus disease 2019 Antigen Rapid Test of nasopharyngeal samples in pediatric patients with coronavirus disease 2019-compatible symptoms of ≤5 days of evolution. Our study showed ... ...

    Abstract We conducted a multicenter clinical validity study of the Panbio coronavirus disease 2019 Antigen Rapid Test of nasopharyngeal samples in pediatric patients with coronavirus disease 2019-compatible symptoms of ≤5 days of evolution. Our study showed limited accuracy in nasopharyngeal antigen testing: overall sensitivity was 45.4%, and 99.8% of specificity, positive-predictive value was 92.5%.
    MeSH term(s) Adolescent ; Antigens, Viral/analysis ; COVID-19/diagnosis ; COVID-19/virology ; Child ; Child, Preschool ; DNA, Viral/analysis ; Female ; Humans ; Infant ; Infant, Newborn ; Male ; Nasopharynx/virology ; Pandemics ; Reproducibility of Results ; Reverse Transcriptase Polymerase Chain Reaction/methods ; SARS-CoV-2/genetics ; SARS-CoV-2/immunology
    Chemical Substances Antigens, Viral ; DNA, Viral
    Language English
    Publishing date 2021-01-21
    Publishing country United States
    Document type Comparative Study ; Journal Article ; Multicenter Study
    ZDB-ID 3102-1
    ISSN 1097-6833 ; 0022-3476
    ISSN (online) 1097-6833
    ISSN 0022-3476
    DOI 10.1016/j.jpeds.2021.01.027
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: New perspectives on respiratory syncytial virus surveillance at the national level: lessons from the COVID-19 pandemic.

    Teirlinck, Anne C / Johannesen, Caroline K / Broberg, Eeva K / Penttinen, Pasi / Campbell, Harry / Nair, Harish / Reeves, Rachel M / Bøås, Håkon / Brytting, Mia / Cai, Wei / Carnahan, AnnaSara / Casalegno, Jean-Sebastien / Danis, Kostas / De Gascun, Cillian / Ellis, Joanna / Emborg, Hanne-Dorthe / Gijon, Manuel / Guiomar, Raquel / Hirve, Siddhivinayak S /
    Jiřincová, Helena / Nohynek, Hanna / Oliva, Jesus Angel / Osei-Yeboah, Richard / Paget, John / Pakarna, Gatis / Pebody, Richard / Presser, Lance / Rapp, Marie / Reiche, Janine / Rodrigues, Ana Paula / Seppälä, Elina / Socan, Maja / Szymanski, Karol / Trebbien, Ramona / Večeřová, Jaromíra / van der Werf, Sylvie / Zambon, Maria / Meijer, Adam / Fischer, Thea K

    The European respiratory journal

    2023  Volume 61, Issue 4

    MeSH term(s) Humans ; Pandemics ; COVID-19/epidemiology ; Respiratory Syncytial Virus, Human ; Respiratory Syncytial Virus Infections/epidemiology ; Respiratory Tract Infections/epidemiology
    Language English
    Publishing date 2023-04-03
    Publishing country England
    Document type Editorial ; Research Support, Non-U.S. Gov't
    ZDB-ID 639359-7
    ISSN 1399-3003 ; 0903-1936
    ISSN (online) 1399-3003
    ISSN 0903-1936
    DOI 10.1183/13993003.01569-2022
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: Recommendations for respiratory syncytial virus surveillance at the national level.

    Teirlinck, Anne C / Broberg, Eeva K / Stuwitz Berg, Are / Campbell, Harry / Reeves, Rachel M / Carnahan, AnnaSara / Lina, Bruno / Pakarna, Gatis / Bøås, Håkon / Nohynek, Hanna / Emborg, Hanne-Dorthe / Nair, Harish / Reiche, Janine / Oliva, Jesus Angel / O'Gorman, Joanne / Paget, John / Szymanski, Karol / Danis, Kostas / Socan, Maja /
    Gijon, Manuel / Rapp, Marie / Havlíčková, Martina / Trebbien, Ramona / Guiomar, Raquel / Hirve, Siddhivinayak S / Buda, Silke / van der Werf, Sylvie / Meijer, Adam / Fischer, Thea K

    The European respiratory journal

    2021  Volume 58, Issue 3

    Abstract: Respiratory syncytial virus (RSV) is a common cause of acute lower respiratory tract infections and hospitalisations among young children and is globally responsible for many deaths in young children, especially in infants aged <6 months. Furthermore, ... ...

    Abstract Respiratory syncytial virus (RSV) is a common cause of acute lower respiratory tract infections and hospitalisations among young children and is globally responsible for many deaths in young children, especially in infants aged <6 months. Furthermore, RSV is a common cause of severe respiratory disease and hospitalisation among older adults. The development of new candidate vaccines and monoclonal antibodies highlights the need for reliable surveillance of RSV. In the European Union (EU), no up-to-date general recommendations on RSV surveillance are currently available. Based on outcomes of a workshop with 29 European experts in the field of RSV virology, epidemiology and public health, we provide recommendations for developing a feasible and sustainable national surveillance strategy for RSV that will enable harmonisation and data comparison at the European level. We discuss three surveillance components: active sentinel community surveillance, active sentinel hospital surveillance and passive laboratory surveillance, using the EU acute respiratory infection and World Health Organization (WHO) extended severe acute respiratory infection case definitions. Furthermore, we recommend the use of quantitative reverse transcriptase PCR-based assays as the standard detection method for RSV and virus genetic characterisation, if possible, to monitor genetic evolution. These guidelines provide a basis for good quality, feasible and affordable surveillance of RSV. Harmonisation of surveillance standards at the European and global level will contribute to the wider availability of national level RSV surveillance data for regional and global analysis, and for estimation of RSV burden and the impact of future immunisation programmes.
    MeSH term(s) Aged ; Child ; Child, Preschool ; Hospitalization ; Humans ; Infant ; Respiratory Syncytial Virus Infections/diagnosis ; Respiratory Syncytial Virus Infections/epidemiology ; Respiratory Syncytial Virus Infections/prevention & control ; Respiratory Syncytial Virus, Human ; Respiratory Tract Infections/diagnosis ; Respiratory Tract Infections/epidemiology ; Sentinel Surveillance
    Language English
    Publishing date 2021-10-01
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 639359-7
    ISSN 1399-3003 ; 0903-1936
    ISSN (online) 1399-3003
    ISSN 0903-1936
    DOI 10.1183/13993003.03766-2020
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: Aetiology of acute respiratory infection in preschool children requiring hospitalisation in Europe-results from the PED-MERMAIDS multicentre case-control study.

    Kohns Vasconcelos, Malte / Loens, Katherine / Sigfrid, Louise / Iosifidis, Elias / Epalza, Cristina / Donà, Daniele / Matheeussen, Veerle / Papachristou, Savvas / Roilides, Emmanuel / Gijon, Manuel / Rojo, Pablo / Minotti, Chiara / Da Dalt, Liviana / Islam, Samsul / Jarvis, Jessica / Syggelou, Aggeliki / Tsolia, Maria / Nyirenda Nyang'wa, Maggie / Keers, Sophie /
    Renk, Hanna / Gemmel, Anna-Lena / D'Amore, Carmen / Ciofi Degli Atti, Marta / Rodríguez-Tenreiro Sánchez, Carmen / Martinón-Torres, Federico / Burokienė, Sigita / Goetghebuer, Tessa / Spoulou, Vana / Riordan, Andrew / Calvo, Cristina / Gkentzi, Despoina / Hufnagel, Markus / Openshaw, Peter J / de Jong, Menno D / Koopmans, Marion / Goossens, Herman / Ieven, Margareta / Fraaij, Pieter L A / Giaquinto, Carlo / Bielicki, Julia A / Horby, Peter / Sharland, Michael

    BMJ open respiratory research

    2021  Volume 8, Issue 1

    Abstract: Background: Both pathogenic bacteria and viruses are frequently detected in the nasopharynx (NP) of children in the absence of acute respiratory infection (ARI) symptoms. The aim of this study was to estimate the aetiological fractions for ARI ... ...

    Abstract Background: Both pathogenic bacteria and viruses are frequently detected in the nasopharynx (NP) of children in the absence of acute respiratory infection (ARI) symptoms. The aim of this study was to estimate the aetiological fractions for ARI hospitalisation in children for respiratory syncytial virus (RSV) and influenza virus and to determine whether detection of specific respiratory pathogens on NP samples was associated with ARI hospitalisation.
    Methods: 349 children up to 5 years of age hospitalised for ARI (following a symptom-based case definition) and 306 hospital controls were prospectively enrolled in 16 centres across seven European Union countries between 2016 and 2019. Admission day NP swabs were analysed by multiplex PCR for 25 targets.
    Results: RSV was the leading single cause of ARI hospitalisations, with an overall population attributable fraction (PAF) of 33.4% and high seasonality as well as preponderance in younger children. Detection of RSV on NP swabs was strongly associated with ARI hospitalisation (OR adjusted for age and season: 20.6, 95% CI: 9.4 to 45.3). Detection of three other viral pathogens showed strong associations with ARI hospitalisation: influenza viruses had an adjusted OR of 6.1 (95% CI: 2.5 to 14.9), parainfluenza viruses (PIVs) an adjusted OR of 4.6 (95% CI: 1.8 to 11.3) and metapneumoviruses an adjusted OR of 4.5 (95% CI: 1.3 to 16.1). Influenza viruses had a PAF of 7.9%, PIVs of 6.5% and metapneumoviruses of 3.0%. In contrast, most other pathogens were found in similar proportions in cases and controls, including
    Conclusion: RSV is the predominant cause of ARI hospitalisations in young children in Europe and its detection, as well as detection of influenza virus, PIV or metapneumovirus, on NP swabs can establish aetiology with high probability. PAFs for RSV and influenza virus are highly seasonal and age dependent.
    MeSH term(s) Case-Control Studies ; Child, Preschool ; Hospitalization ; Humans ; Respiratory Syncytial Virus Infections/diagnosis ; Respiratory Syncytial Virus Infections/epidemiology ; Respiratory Syncytial Virus, Human ; Respiratory Tract Infections/epidemiology
    Language English
    Publishing date 2021-07-29
    Publishing country England
    Document type Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
    ZDB-ID 2736454-9
    ISSN 2052-4439 ; 2052-4439
    ISSN (online) 2052-4439
    ISSN 2052-4439
    DOI 10.1136/bmjresp-2021-000887
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