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845 results on '"Jacqz-Aigrain, Evelyne"'

104. Precision therapy of 6‐mercaptopurine in Chinese children with acute lymphoblastic leukaemia

Author

Zhou, Yue, primary, Wang, Li, additional, Zhai, Xiao‐Ying, additional, Wen, Li, additional, Tang, Fang, additional, Yang, Fan, additional, Liu, Xi‐Ting, additional, Dong, Lei, additional, Zhi, Li‐Juan, additional, Shi, Hai‐Yan, additional, Hao, Guo‐Xiang, additional, Zheng, Yi, additional, Jacqz‐Aigrain, Evelyne, additional, Wang, Tian‐You, additional, and Zhao, Wei, additional

Published
2020
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108. Developmental Pharmacogenetics of SLCO2B1 on Montelukast Pharmacokinetics in Chinese Children

Author

Li, Qian, primary, Wang, Kai, additional, Shi, Hai-Yan, additional, Wu, Yue-E, additional, Zhou, Yue, additional, Kan, Min, additional, Zheng, Yi, additional, Hao, Guo-Xiang, additional, Yang, Xin-Mei, additional, Yang, Yi-Lei, additional, Su, Le-Qun, additional, Wang, Xiao-Ling, additional, Jacqz-Aigrain, Evelyne, additional, Zhou, Jun, additional, and Zhao, Wei, additional

Published
2019
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117. Characteristics of prescription in 29 Level 3 Neonatal Wards over a 2-year period (2017-2018). An inventory for future research

Author

Gouyon, Béatrice, primary, Martin-Mons, Séverine, additional, Iacobelli, Silvia, additional, Razafimahefa, Hasinirina, additional, Kermorvant-Duchemin, Elsa, additional, Brat, Roselyne, additional, Caeymaex, Laurence, additional, Couringa, Yvan, additional, Alexandre, Ceneric, additional, Lafon, Catherine, additional, Ramful, Duksha, additional, Bonsante, Francesco, additional, Binson, Guillaume, additional, Flamein, Florence, additional, Moussy-Durandy, Amélie, additional, Di Maio, Massimo, additional, Mazeiras, Gaël, additional, Girard, Olivier, additional, Desbruyeres, Cécile, additional, Mourdie, Julien, additional, Escourrou, Guillaume, additional, Flechelles, Olivier, additional, Abasse, Soumeth, additional, Rosenthal, Jean-Marc, additional, Pages, Anne-Sophie, additional, Dorsi, Marine, additional, Karaoui, Léila, additional, ElGellab, Abdellah, additional, Le Bail Dantec, Florence, additional, Yangui, Mohamed-Amine, additional, Norbert, Karine, additional, Kugbe, Yaovi, additional, Lorrain, Simon, additional, Pignolet, Anaelle, additional, Garnier, Elodie Marie, additional, Lapillonne, Alexandre, additional, Mitanchez, Delphine, additional, Jacqz-Aigrain, Evelyne, additional, and Gouyon, Jean-Bernard, additional

Published
2019
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119. Population Pharmacokinetics and Dosing Optimization of Imipenem in Children with Hematological Malignancies

Author

Dong, Lei, primary, Zhai, Xiao-Ying, additional, Yang, Yi-Lei, additional, Wang, Li, additional, Zhou, Yue, additional, Shi, Hai-Yan, additional, Tang, Bo-Hao, additional, Wu, Yue-E, additional, Yang, Fan, additional, Wen, Li, additional, Kong, Hong-Xiao, additional, Zhi, Li-Juan, additional, Jacqz-Aigrain, Evelyne, additional, and Zhao, Wei, additional

Published
2019
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120. Population pharmacokinetic meta-analysis of individual data to design the first randomized efficacy trial of vancomycin in neonates and young infants

Author

Jacqz-Aigrain, Evelyne, primary, Leroux, Stéphanie, additional, Thomson, Alison H, additional, Allegaert, Karel, additional, Capparelli, Edmund V, additional, Biran, Valérie, additional, Simon, Nicolas, additional, Meibohm, Bernd, additional, Lo, Yoke-Lin, additional, Marques, Remedios, additional, Peris, José-Esteban, additional, Lutsar, Irja, additional, Saito, Jumpei, additional, Nakamura, Hidefumi, additional, van den Anker, Johannes N, additional, Sharland, Mike, additional, and Zhao, Wei, additional

Published
2019
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121. Melatonin Levels in Preterm and Term Infants and Their Mothers

Author

Biran, Valérie, primary, Decobert, Fabrice, additional, Bednarek, Nathalie, additional, Boizeau, Priscilla, additional, Benoist, Jean-François, additional, Claustrat, Bruno, additional, Barré, Jérôme, additional, Colella, Marina, additional, Frérot, Alice, additional, Garnotel, Roselyne, additional, Graesslin, Olivier, additional, Haddad, Bassam, additional, Launay, Jean-Marie, additional, Schmitz, Thomas, additional, Schroedt, Julien, additional, Virlouvet, Anne-Laure, additional, Guilmin-Crépon, Sophie, additional, Yacoubi, Adyla, additional, Jacqz-Aigrain, Evelyne, additional, Gressens, Pierre, additional, Alberti, Corinne, additional, and Baud, Olivier, additional

Published
2019
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125. Developmental population pharmacokinetics of caffeine in Chinese premature infants with apnoea of prematurity: A post‐marketing study to support paediatric labelling in China.

Author

Gao, Xiang‐Bo, Zheng, Yi, Yang, Fan, Wang, Chen‐Hong, Jiang, Zhou‐Hong, Wu, Yue‐E, Jacqz‐Aigrain, Evelyne, Ni, Shao‐Qing, and Zhao, Wei

Subjects
POPULATION of China, PREMATURE infants, ALLOMETRY, PHARMACOKINETICS, CAFFEINE, MONTE Carlo method, APNEA of prematurity, CHINESE people
Abstract

Aims: The aim of the study was to evaluate the suitability of the current caffeine dosing regimen for the Chinese population using modelling and simulation approach. Methods: Pharmacokinetic samples were collected from 99 Chinese newborns with premature apnoea. The median (range) of gestational age and postmenstrual age were 28.3 (25.0–33.4) weeks and 31.1 (26.4–38.0) weeks, respectively. Newborns were receiving caffeine citrate at a loading dose of 20 mg/kg/d and a maintenance dose of 5–10 mg/kg/d. Caffeine concentrations and CYP1A2 polymorphisms were investigated. Population pharmacokinetic modelling of caffeine in Chinese preterm newborn on a population‐wide scale was conducted using NONMEM. Results: A 1‐compartment model with first‐order elimination was used to describe population pharmacokinetic. With current weight implemented using 0.75 allometric scaling, clearance (CL) was positively related to current weight and postmenstrual age, but a negative relationship was observed with serum creatinine concentration. Eight genotypes of CYP1A2 were tested and none of them had a significant impact on caffeine pharmacokinetic parameters. Interindividual variability of CL and volume of distribution was 7.70 and 65.9%. The median (range) of 95% confidence intervals of CL were 0.0128 (0.0128–0.0131) L/h/kg. Monte Carlo simulation demonstrated that 80% (loading dose) and 98% (maintenance dose) of premature infants treated with a labelled dosing regimen attained the concentration target range of 5–20 mg/L. Conclusion: A population PK model of caffeine was developed in Chinese newborns. Body weight‐implemented allometric scaling, postmenstrual age and serum creatinine concentration markedly affected caffeine clearance. The labelled dosing regimen is suitable for Chinese premature infants. [ABSTRACT FROM AUTHOR]

Published
2021
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126. Population pharmacokinetics and dosing optimization of azlocillin in neonates with early-onset sepsis: a real-world study.

Author

Wu, Yue-E, Wang, Tao, Yang, Hua-Liang, Tang, Bo-Hao, Kong, Li, Li, Xin, Gao, Qi, Li, Xue, Yao, Bu-Fan, Shi, Hai-Yan, Huang, Xin, Wang, Wen-Qi, Jacqz-Aigrain, Evelyne, Allegaert, Karel, van den Anker, John, Tian, Xiu-Ying, and Zhao, Wei

Subjects
ANTIBIOTICS, RESEARCH, CLINICAL trials, RESEARCH methodology, MEDICAL cooperation, EVALUATION research, SEPSIS, COMPARATIVE studies, AMPICILLIN, MICROBIAL sensitivity tests, LONGITUDINAL method
Abstract

Objectives: Nowadays, real-world data can be used to improve currently available dosing guidelines and to support regulatory approval of drugs for use in neonates by overcoming practical and ethical hurdles. This proof-of-concept study aimed to assess the population pharmacokinetics of azlocillin in neonates using real-world data, to make subsequent dose recommendations and to test these in neonates with early-onset sepsis (EOS).Methods: This prospective, open-label, investigator-initiated study of azlocillin in neonates with EOS was conducted using an adaptive two-step design. First, a maturational pharmacokinetic-pharmacodynamic model of azlocillin was developed, using an empirical dosing regimen combined with opportunistic samples resulting from waste material. Second, a Phase II clinical trial (ClinicalTrials.gov: NCT03932123) of this newly developed model-based dosing regimen of azlocillin was conducted to assure optimized target attainment [free drug concentration above MIC during 70% of the dosing interval ('70% fT>MIC')] and to investigate the tolerance and safety in neonates.Results: A one-compartment model with first-order elimination, using 167 azlocillin concentrations from 95 neonates (31.7-41.6 weeks postmenstrual age), incorporating current weight and renal maturation, fitted the data best. For the second step, 45 neonates (30.3-41.3 weeks postmenstrual age) were subsequently included to investigate target attainment, tolerance and safety of the pharmacokinetic-pharmacodynamic model-based dose regimen (100 mg/kg q8h). Forty-three (95.6%) neonates reached their pharmacokinetic target and only two neonates experienced adverse events (feeding intolerance and abnormal liver function), possibly related to azlocillin.Conclusions: Target attainment, tolerance and safety of azlocillin was shown in neonates with EOS using a pharmacokinetic-pharmacodynamic model developed with real-world data. [ABSTRACT FROM AUTHOR]

Published
2021
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127. Extremely low dose of 6‐mercaptopurine in a Chinese child with acute lymphoblastic leukaemia and multiple pharmacogenetic mutations.

Author

Zhai, Xiao‐Ying, Zhou, Yue, Dong, Lei, Nie, Ai‐Qing, Zhi, Li‐Juan, Jacqz‐Aigrain, Evelyne, Wang, Tian‐You, Wang, Li, and Zhao, Wei

Subjects
ANTIMETABOLITES, DRUG monitoring, LEUCOPENIA, LYMPHOBLASTIC leukemia, GENETIC mutation, PHARMACOGENOMICS, DISEASE risk factors, CHILDREN
Abstract

What is known and objectives: Thiopurines are cornerstone drugs in the treatment of acute lymphoblastic leukaemia (ALL), but their use can be complicated by the incidence of life‐threatening leucopenia. Case description: We describe a case of a 6‐year‐old Chinese boy with B‐ALL receiving extremely low dose of 6‐mercaptopurine (only 4% of recommended dose) during the ALL maintenance therapy phase. What is new and conclusion: Complex pharmacogenetic tests and TDM should be recommended in children with complicated ALL to highlight the large individual variability in the responses to 6‐MP exposure and the associated adverse effects. [ABSTRACT FROM AUTHOR]

Published
2021
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132. Dose-Finding Study of Omeprazole on Gastric pH in Neonates with Gastro-Esophageal Acid Reflux Using a Bayesian Sequential Approach

Author

Kaguelidou , Florentia, Alberti , Corinne, Biran , Valerie, Bourdon , Olivier, Farnoux , Caroline, Zohar , Sarah, Jacqz-Aigrain , Evelyne, Unité de Pharmacologie Pédiatrique et Pharmacogénétique (UPPP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Diderot - Paris 7 (UPD7), Evaluation thérapeutique et pharmacologie périnatale et pédiatrique (EA_7323), Université Paris Descartes - Paris 5 (UPD5), Centre d'Investigation Clinique - Epidemiologie Clinique/essais Cliniques Hopital Robert Debre, Institut National de la Santé et de la Recherche Médicale (INSERM), Epidémiologie Clinique et Evaluation Economique Appliquées aux Populations Vulnérables (ECEVE (U1123 / UMR_S_1123)), Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM)-AP-HP Hôpital universitaire Robert-Debré [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Dpt néonatalogie [CHU Debré], AP-HP Hôpital universitaire Robert-Debré [Paris], Laboratoire Educations et Pratiques de Santé (LEPS), Université Paris 13 (UP13)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Dpt pharmacie [CHU Debré], Université Pierre et Marie Curie - Paris 6 (UPMC), Centre de Recherche des Cordeliers (CRC), Université Pierre et Marie Curie - Paris 6 (UPMC)-École pratique des hautes études (EPHE), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM), HAL UPMC, Gestionnaire, Université Pierre et Marie Curie - Paris 6 (UPMC)-École Pratique des Hautes Études (EPHE), Unité de Pharmacologie Pédiatrique et Pharmacogénétique ( UPPP ), Université Paris Diderot - Paris 7 ( UPD7 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Evaluation des thérapeutiques et pharmacologie périnatale et pédiatrique, Université Paris Diderot - Paris 7 ( UPD7 ), Institut National de la Santé et de la Recherche Médicale ( INSERM ), Epidémiologie Clinique et Evaluation Economique Appliquées aux Populations Vulnérables ( Inserm U1123 - ECEVE ), AP-HP Hôpital universitaire Robert-Debré [Paris]-Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université Paris Diderot - Paris 7 ( UPD7 ), Laboratoire Educations et Pratiques de Santé ( LEPS ), Université Paris 13 ( UP13 ) -Université Sorbonne Paris Cité ( USPC ), Université Pierre et Marie Curie - Paris 6 ( UPMC ), Centre de Recherche des Cordeliers ( CRC ), and Université Paris Diderot - Paris 7 ( UPD7 ) -École pratique des hautes études ( EPHE ) -Université Pierre et Marie Curie - Paris 6 ( UPMC ) -Université Paris Descartes - Paris 5 ( UPD5 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM )

Subjects
Male, Physiology, Cell Membranes, Administration, Oral, lcsh:Medicine, Pathology and Laboratory Medicine, Pediatrics, Hospitals, University, Mathematical and Statistical Techniques, Heart Rate, Medicine and Health Sciences, lcsh:Science, [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, Proton Pumps, Chemistry, Physical Sciences, Gastroesophageal Reflux, Female, Cellular Structures and Organelles, Omeprazole, Statistics (Mathematics), Research Article, Chemical Elements, Esophageal pH Monitoring, Vomiting, Cardiology, Gestational Age, Research and Analysis Methods, Signs and Symptoms, Diagnostic Medicine, [ SDV.MHEP ] Life Sciences [q-bio]/Human health and pathology, Intensive Care Units, Neonatal, Bradycardia, Humans, Statistical Methods, Secretion, Dose-Response Relationship, Drug, lcsh:R, Infant, Newborn, Infant, Biology and Life Sciences, Neonates, Membrane Proteins, Bayes Theorem, Cell Biology, Length of Stay, Anti-Ulcer Agents, Oxygen, lcsh:Q, Physiological Processes, Mathematics, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Developmental Biology, Meta-Analysis
Abstract

International audience; ObjectiveProton pump inhibitors are frequently administered on clinical symptoms in neonates but benefit remains controversial. Clinical trials validating omeprazole dosage in neonates are limited. The objective of this trial was to determine the minimum effective dose (MED) of omeprazole to treat pathological acid reflux in neonates using reflux index as surrogate marker.DesignDouble blind dose-finding trial with continual reassessment method of individual dose administration using a Bayesian approach, aiming to select drug dose as close as possible to the predefined target level of efficacy (with a credibility interval of 95%).SettingNeonatal Intensive Care unit of the Robert Debré University Hospital in Paris, France.PatientsNeonates with a postmenstrual age ≥ 35 weeks and a pathologic 24-hour intra-esophageal pH monitoring defined by a reflux index ≥ 5% over 24 hours were considered for participation. Recruitment was stratified to 3 groups according to gestational age at birth.InterventionFive preselected doses of oral omeprazole from 1 to 3 mg/kg/day.Main outcome measuresPrimary outcome, measured at 35 weeks postmenstrual age or more, was a reflux index

Published
2016

134. An optimised dosing regimen versus a standard dosing regimen of vancomycin for the treatment of late onset sepsis due to Gram-positive microorganisms in neonates and infants aged less than 90 days (NeoVanc): study protocol for a randomised controlled trial.

Author

Hill, Louise F., Turner, Mark A., Lutsar, Irja, Heath, Paul T., Hardy, Pollyanna, Linsell, Louise, Jacqz-Aigrain, Evelyne, Roilides, Emmanuel, Sharland, Mike, for the NeoVanc Consortium, Giaquinto, Carlo, Bilardi, Davide, Planche, Timothy, Huertas, Tatiana Munera, Hope, William, Zhao, Wei, Ghazal, Peter, Dotta, Andrea, de la Cruz, Javier, and Díaz, Clara Alonso

Subjects
NEONATAL sepsis, NEWBORN infants, SEPSIS, INFANTS, STAPHYLOCOCCUS aureus, VANCOMYCIN
Abstract

Background: Vancomycin has been used in clinical practice for over 50 years; however, validated, pharmacokinetic (PK) data relating clinical outcomes to different dosing regimens in neonates are lacking. Coagulase negative staphylococci (CoNS) are the most commonly isolated organisms in neonatal, late-onset sepsis (LOS). Optimised use to maximise efficacy while minimising toxicity and resistance selection is imperative to ensure vancomycin's continued efficacy.Methods: NeoVanc is a European, open-label, Phase IIb, randomised, controlled, non-inferiority trial comparing an optimised vancomycin regimen to a standard vancomycin regimen when treating LOS known/suspected to be caused by Gram-positive organisms (excluding Staphylococcus aureus) in infants aged ≤ 90 days. Three hundred infants will be recruited and randomised in a 1:1 ratio. Infants can be recruited if they have culture confirmed (a positive culture from a normally sterile site and at least one clinical/laboratory criterion) or clinical sepsis (presence of any ≥ 3 clinical/laboratory criteria) in the 24 h before randomisation. The optimised regimen consists of a vancomycin loading dose (25 mg/kg) followed by 5 ± 1 days of 15 mg/kg q12h or q8h, dependent on postmenstrual age (PMA). The standard regimen is a 10 ± 2 day vancomycin course at 15 mg/kg q24h, q12h or q8h, dependent on PMA. The primary endpoint is a successful outcome at the test of cure visit (10 ± 1 days after the end of vancomycin therapy). A successful outcome consists of the patient being alive, having successfully completed study vancomycin therapy and having not had a clinical/microbiological relapse/new infection requiring treatment with vancomycin or other anti-staphylococcal antibiotic for > 24 h. Secondary endpoints include clinical/microbiological relapse/new infection at the short-term follow-up visit (30 ± 5 days after the initiation of vancomycin), evaluation of safety (renal/hearing), vancomycin PK and assessment of a host biomarker panel over the course of vancomycin therapy.Discussion: Based on previous pre-clinical data and a large meta-analysis of neonatal, PK/pharmacodynamic data, NeoVanc was set up to provide evidence on whether a loading dose followed by a short vancomycin course is non-inferior, regarding efficacy, when compared to a standard, longer course. If non-inferiority is demonstrated, this would support adoption of the optimised regimen as a way of safely reducing vancomycin exposure when treating neonatal, Gram-positive LOS.Trial Registration: ClinicalTrials.gov, NCT02790996. Registered on 7 April 2016. EudraCT, 2015-000203-89. Entered on 18 July 2016. [ABSTRACT FROM AUTHOR]

Published
2020
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135. Reporting of offspring data in diabetes, HIV infection and hypertension trials during pregnancy: a systematic review.

Author

Aurich, Beate, Martin-Montoya, Tania, Daolun Zhang, Jacqz-Aigrain, Evelyne, and Zhang, Daolun

Subjects
HIV infections, META-analysis, ANGIOTENSIN-receptor blockers, HYPERTENSION, ONLINE information services, MEDICAL information storage & retrieval systems, SYSTEMATIC reviews, DIABETES, GESTATIONAL age, PRENATAL exposure delayed effects, PREGNANCY outcomes, PREGNANCY complications, BIRTH weight, PRENATAL care, DEMOGRAPHY, MEDLINE
Abstract

Background: Clinical trials are conducted during pregnancy to evaluate benefits and risks of medicines for mother and child. The safety of maternal treatments is a key issue for healthcare professionals and parents.Objective: To analyse offspring data reported in clinical trials in pregnant women with diabetes, HIV infection or hypertension (three of the most common diseases in women of childbearing potential) and either treated prior to pregnancy for these chronic diseases or diagnosed and treated during pregnancy.Methods: PubMed and Embase (1 January 1997 to 31 December 2017) were searched for drug trials in pregnant women with diabetes, HIV infection or hypertension. Titles and abstracts were screened, followed by a full-text review of eligible articles. Inclusion criteria were interventional clinical trials in pregnant women treated with medication and full text in English. Trial characteristics, maternal and offspring data were extracted. Data were summarised by disease and study. Twelve key items were considered for the offspring.Results: Overall, 196 articles reporting 132 clinical trials (diabetes n=55; HIV n=59; hypertension n=18) were included. Key offspring data were frequently not reported, for example, number of births (diabetes: 22/55, 40%; HIV: 14/59, 24%; hypertension: 10/18, 56%). Congenital malformations were often not reported with sufficient detail (diabetes: 40/55, 73%; HIV: 39/59, 66%; hypertension: 17/18, 94%). Similar observations were made for other key items (eg, fetal losses, neonatal deaths).Conclusion: Under-reporting of key data for the offspring was frequent in publications of clinical trials in pregnant women with diabetes, HIV infection or hypertension making the assessment of the benefit-risk ratio of treatment options during pregnancy difficult.Trial Registration Number: CRD42017057024. [ABSTRACT FROM AUTHOR]

Published
2020
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137. Population Pharmacokinetics and Dosing Optimization of Azithromycin in Children with Community-Acquired Pneumonia

Author

Zheng, Yi, primary, Liu, Shu-Ping, additional, Xu, Bao-Ping, additional, Shi, Zhong-Ren, additional, Wang, Kai, additional, Yang, Jin-Bin, additional, Huang, Xin, additional, Tang, Bo-Hao, additional, Chen, Xing-Kai, additional, Shi, Hai-Yan, additional, Zhou, Yue, additional, Wu, Yue-E, additional, Qi, Hui, additional, Jacqz-Aigrain, Evelyne, additional, Shen, A-Dong, additional, and Zhao, Wei, additional

Published
2018
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139. Transethnic, Genome-Wide Analysis Reveals Immune-Related Risk Alleles and Phenotypic Correlates in Pediatric Steroid-Sensitive Nephrotic Syndrome

Author

Debiec, Hanna, primary, Dossier, Claire, additional, Letouzé, Eric, additional, Gillies, Christopher E., additional, Vivarelli, Marina, additional, Putler, Rosemary K., additional, Ars, Elisabet, additional, Jacqz-Aigrain, Evelyne, additional, Elie, Valery, additional, Colucci, Manuela, additional, Debette, Stéphanie, additional, Amouyel, Philippe, additional, Elalaoui, Siham C., additional, Sefiani, Abdelaziz, additional, Dubois, Valérie, additional, Simon, Tabassome, additional, Kretzler, Matthias, additional, Ballarin, Jose, additional, Emma, Francesco, additional, Sampson, Matthew G., additional, Deschênes, Georges, additional, and Ronco, Pierre, additional

Published
2018
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