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2. A physiological approach to renal clearance:From premature neonates to adults

Author

Holford, Nick, O'Hanlon, Conor J., Allegaert, Karel, Anderson, Brian, Falcao, Amilcar, Simon, Nicolas, Lo, Yoke-Lin, Thomson, Alison H., Sherwin, Catherine M., Jacqz-Aigrain, Evelyne, Llanos-Paez, Carolina, Hennig, Stefanie, Mockus, Linas, Kirkpatrick, Carl, Holford, Nick, O'Hanlon, Conor J., Allegaert, Karel, Anderson, Brian, Falcao, Amilcar, Simon, Nicolas, Lo, Yoke-Lin, Thomson, Alison H., Sherwin, Catherine M., Jacqz-Aigrain, Evelyne, Llanos-Paez, Carolina, Hennig, Stefanie, Mockus, Linas, and Kirkpatrick, Carl

Abstract

Aims: We propose using glomerular filtration rate (GFR) as the physiological basis for distinguishing components of renal clearance. Methods: Gentamicin, amikacin and vancomycin are thought to be predominantly excreted by the kidneys. A mixed-effects joint model of the pharmacokinetics of these drugs was developed, with a wide dispersion of weight, age and serum creatinine. A dataset created from 18 sources resulted in 27,338 drug concentrations from 9,901 patients. Body size and composition, maturation and renal function were used to describe differences in drug clearance and volume of distribution. Results: This study demonstrates that GFR is a predictor of two distinct components of renal elimination clearance: (1) GFR clearance associated with normal GFR and (2) non-GFR clearance not associated with normal GFR. All three drugs had GFR clearance estimated as a drug-specific percentage of normal GFR (gentamicin 39%, amikacin 90% and vancomycin 57%). The total clearance (sum of GFR and non-GFR clearance), standardized to 70 kg total body mass, 176 cm, male, renal function 1, was 5.58 L/h (95% confidence interval [CI] 5.50-5.69) (gentamicin), 7.77 L/h (95% CI 7.26-8.19) (amikacin) and 4.70 L/h (95% CI 4.61-4.80) (vancomycin). Conclusions: GFR provides a physiological basis for renal drug elimination. It has been used to distinguish two elimination components. This physiological approach has been applied to describe clearance and volume of distribution from premature neonates to elderly adults with a wide dispersion of size, body composition and renal function. Dose individualization has been implemented using target concentration intervention.

Published
2024

3. A physiological approach to renal clearance: From premature neonates to adults.

Author

Holford, Nick, O'Hanlon, Conor J., Allegaert, Karel, Anderson, Brian, Falcão, Amilcar, Simon, Nicolas, Lo, Yoke‐Lin, Thomson, Alison H., Sherwin, Catherine M., Jacqz‐Aigrain, Evelyne, Llanos‐Paez, Carolina, Hennig, Stefanie, Mockus, Linas, and Kirkpatrick, Carl

Subjects
PREMATURE infants, NEWBORN infants, ADULTS, KIDNEY physiology, GLOMERULAR filtration rate, BODY composition
Abstract

Aims: We propose using glomerular filtration rate (GFR) as the physiological basis for distinguishing components of renal clearance. Methods: Gentamicin, amikacin and vancomycin are thought to be predominantly excreted by the kidneys. A mixed‐effects joint model of the pharmacokinetics of these drugs was developed, with a wide dispersion of weight, age and serum creatinine. A dataset created from 18 sources resulted in 27,338 drug concentrations from 9,901 patients. Body size and composition, maturation and renal function were used to describe differences in drug clearance and volume of distribution. Results: This study demonstrates that GFR is a predictor of two distinct components of renal elimination clearance: (1) GFR clearance associated with normal GFR and (2) non‐GFR clearance not associated with normal GFR. All three drugs had GFR clearance estimated as a drug‐specific percentage of normal GFR (gentamicin 39%, amikacin 90% and vancomycin 57%). The total clearance (sum of GFR and non‐GFR clearance), standardized to 70 kg total body mass, 176 cm, male, renal function 1, was 5.58 L/h (95% confidence interval [CI] 5.50‐5.69) (gentamicin), 7.77 L/h (95% CI 7.26‐8.19) (amikacin) and 4.70 L/h (95% CI 4.61‐4.80) (vancomycin). Conclusions: GFR provides a physiological basis for renal drug elimination. It has been used to distinguish two elimination components. This physiological approach has been applied to describe clearance and volume of distribution from premature neonates to elderly adults with a wide dispersion of size, body composition and renal function. Dose individualization has been implemented using target concentration intervention. [ABSTRACT FROM AUTHOR]

Published
2024
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5. Key factors associated with 6‐thioguanine and 6‐methylmercaptopurine nucleotide concentrations in children treated by thiopurine for acute leukaemia and inflammatory bowel disease.

Author

de Beaumais, Tiphaine Adam, Lorrain, Simon, Mamhoudi, Naura, Simonin, Mathieu, Martinez Vinson, Christine, Medard, Yves, Petit, Arnaud, and Jacqz‐Aigrain, Evelyne

Subjects
INFLAMMATORY bowel diseases, AZATHIOPRINE, ACUTE leukemia, DRUG monitoring, LYMPHOBLASTIC leukemia, ERYTHROCYTES
Abstract

Aims: Azathioprine (AZA) and 6‐mercaptopurine are prescribed in acute lymphoblastic leukaemia (ALL) and inflammatory bowel diseases (IBD). Metabolism to active 6‐thioguanine (6TGN) and 6‐methylmercaptopurine nucleotides (6MMPN) is variable but therapeutic drug monitoring (TDM) remains debatable. This study reports on factors impacting on red blood cell (RBC) metabolites concentrations in children to facilitate TDM interpretation. Methods: The first paediatric TDM samples received during year 2021 were analysed, whatever indication and thiopurine drug. Target concentration ranges were 200–500, <6000 pmol/8 × 108 RBC for 6TGN and 6MMPN. Results: Children (n = 492) had IBD (64.8%), ALL (22.6%) or another autoimmune disease (12.6%): mean ages at TDM were 7.5 in ALL and 13.7 years in IBD (P <.0001). ALL received 6‐mercaptopurine (mean dose 1.7 mg/kg/d with methotrexate), IBD received AZA (1.9 mg/kg/d with anti‐inflammatory drugs and/or monoclonal antibodies). Median 6TGN and 6MMPN concentrations were 213.7 [interquartile range: 142.5; 309.6] and 1144.6 [419.4; 3574.3] pmol/8 × 108 RBC, 38.8% of patients were in the recommended therapeutic range for both compounds. Aminotransferases and blood tests were abnormal in 57/260 patients: 8.1% patients had high alanine aminotransaminase, 3.4% of patients had abnormal blood count. Factors associated with increased 6TGN were age at TDM and thiopurine methyltransferase genotype in ALL and AZA dose in IBD. The impact of associated treatment in IBD patients was also significant. Conclusion: TDM allowed identification of children who do not reach target levels or remain over treated. Including TDM in follow‐up may help physicians to adjust dosage with the aim of reducing adverse effects and improve treatment outcome. [ABSTRACT FROM AUTHOR]

Published
2024
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6. Favorable pharmacokinetics and pharmacodynamics properties of Gilteritinib in cerebrospinal fluid: a potential effective treatment in relapsing meningeal acute myeloid leukaemia FLT3-ITD patients

Author

Vignal, Nicolas, primary, Kelly, Loïs, additional, Lengline, Etienne, additional, Cabannes-Hamy, Aurélie, additional, Siavellis, Justine, additional, Ghez, David, additional, Sauvageon, Hélène, additional, Braun, Thorsten, additional, Jacqz-Aigrain, Evelyne, additional, Kohn, Milena, additional, Rousselot, Philippe, additional, Puissant, Alexandre, additional, Raffoux, Emmanuel, additional, Mourah, Samia, additional, and Goldwirt, Lauriane, additional

Published
2023
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11. How paediatric drug development and use could benefit from OMICs:A c4c expert group white paper

Author

Neumann, Eva, Schreeck, Filippa, Herberg, Jethro, Jacqz Aigrain, Evelyne, Maitland-van der Zee, Anke H., Pérez-Martínez, Antonio, Hawcutt, Daniel B., Schaeffeler, Elke, Rane, Anders, de Wildt, Saskia N., Schwab, Matthias, Neumann, Eva, Schreeck, Filippa, Herberg, Jethro, Jacqz Aigrain, Evelyne, Maitland-van der Zee, Anke H., Pérez-Martínez, Antonio, Hawcutt, Daniel B., Schaeffeler, Elke, Rane, Anders, de Wildt, Saskia N., and Schwab, Matthias

Abstract

The safety and efficacy of pharmacotherapy in children, particularly preterms, neonates and infants, is limited by a paucity of good-quality data from prospective clinical drug trials. A specific challenge is the establishment of valid biomarkers. OMICs technologies may support these efforts by complementary information about targeted and nontargeted molecules through systematic characterization and quantitation of biological samples. OMICs technologies comprise at least genomics, epigenomics, transcriptomics, proteomics, metabolomics and microbiomics in addition to the patient's phenotype. OMICs technologies are in part hypothesis-generating, allowing an in depth understanding of disease pathophysiology and pharmacological mechanisms. Application of OMICs technologies in paediatrics faces major challenges before routine adoption. First, developmental processes need to be considered, including a subdivision into specific age groups as developmental changes clearly impact OMICs data. Second, compared to the adult population, the number of patients is limited as are the type and amount of necessary biomaterial, especially in neonates and preterms. Thus, advanced trial designs and biostatistical methods, noninvasive biomarkers, innovative biobanking concepts including data and samples from healthy children, as well as analytical approaches (eg liquid biopsies) should be addressed to overcome these obstacles. The ultimate goal is to link OMICs technologies with innovative analysis tools, such as artificial intelligence at an early stage. The use of OMICs data based on a feasible approach will contribute to the identification complex phenotypes and subpopulations of patients to improve the development of medicines for children with potential economic advantages.

Published
2022

12. A loss-of-function IFNAR1 allele in Polynesia underlies severe viral diseases in homozygotes

Author

Bastard, Paul, primary, Hsiao, Kuang-Chih, additional, Zhang, Qian, additional, Choin, Jeremy, additional, Best, Emma, additional, Chen, Jie, additional, Gervais, Adrian, additional, Bizien, Lucy, additional, Materna, Marie, additional, Harmant, Christine, additional, Roux, Maguelonne, additional, Hawley, Nicola L., additional, Weeks, Daniel E., additional, McGarvey, Stephen T., additional, Sandoval, Karla, additional, Barberena-Jonas, Carmina, additional, Quinto-Cortés, Consuelo D., additional, Hagelberg, Erika, additional, Mentzer, Alexander J., additional, Robson, Kathryn, additional, Coulibaly, Boubacar, additional, Seeleuthner, Yoann, additional, Bigio, Benedetta, additional, Li, Zhi, additional, Uzé, Gilles, additional, Pellegrini, Sandra, additional, Lorenzo, Lazaro, additional, Sbihi, Zineb, additional, Latour, Sylvain, additional, Besnard, Marianne, additional, Adam de Beaumais, Tiphaine, additional, Jacqz Aigrain, Evelyne, additional, Béziat, Vivien, additional, Deka, Ranjan, additional, Esera Tulifau, Litara, additional, Viali, Satupa‘itea, additional, Reupena, Muagututi‘a Sefuiva, additional, Naseri, Take, additional, McNaughton, Peter, additional, Sarkozy, Vanessa, additional, Peake, Jane, additional, Blincoe, Annaliesse, additional, Primhak, Sarah, additional, Stables, Simon, additional, Gibson, Kate, additional, Woon, See-Tarn, additional, Drake, Kylie Marie, additional, Hill, Adrian V.S., additional, Chan, Cheng-Yee, additional, King, Richard, additional, Ameratunga, Rohan, additional, Teiti, Iotefa, additional, Aubry, Maite, additional, Cao-Lormeau, Van-Mai, additional, Tangye, Stuart G., additional, Zhang, Shen-Ying, additional, Jouanguy, Emmanuelle, additional, Gray, Paul, additional, Abel, Laurent, additional, Moreno-Estrada, Andrés, additional, Minster, Ryan L., additional, Quintana-Murci, Lluis, additional, Wood, Andrew C., additional, and Casanova, Jean-Laurent, additional

Published
2022
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13. How paediatric drug development and use could benefit from OMICs: A c4c expert group white paper

Author

Neumann, Eva, primary, Schreeck, Filippa, additional, Herberg, Jethro, additional, Jacqz Aigrain, Evelyne, additional, Maitland‐van der Zee, Anke H., additional, Pérez‐Martínez, Antonio, additional, Hawcutt, Daniel B., additional, Schaeffeler, Elke, additional, Rane, Anders, additional, de Wildt, Saskia N., additional, and Schwab, Matthias, additional

Published
2022
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15. Outcome associated with prescription of cardiac rehabilitation according to predicted risk after acute myocardial infarction: Insights from the FAST-MI registries

Author

Debiec, Hanna, Dossier, Claire, Letouzé, Eric, Gillies, Christopher, Vivarelli, Marina, Putler, Rosemary, Ars, Elisabet, Jacqz-Aigrain, Evelyne, Elie, Valery, Colucci, Manuela, Debette, Stéphanie, Amouyel, Philippe, Elalaoui, Siham, Sefiani, Abdelaziz, Dubois, Valérie, Kretzler, Matthias, Ballarin, Jose, Emma, Francesco, Sampson, Matthew, Deschênes, Georges, Ronco, Pierre, Ederhy, Stephane, Cohen, Ariel, Boccara, Franck, Aissaoui, Nadia, Elbaz, Meyer, Bonnefoy-Cudraz, Eric, Druelles, Philipe, Andrieu, Stéphane, Angoulvant, Denis, Furber, Alain, Cottin, Yves, Puymirat, Etienne, Bonaca, Marc, Iliou, Marie-Christine, Tea, Victoria, Ducrocq, Grégory, Douard, Hervé, Labrunee, Marc, Plastaras, Philoktimon, Chevallereau, Pierre, Taldir, Guillaume, Bataille, Vincent, Ferrières, Jean, Schiele, François, Simon, Tabassome, Danchin, Nicolas, Centre de Ressources Biologiques APHP-SU (PASS-CRB-APHP-SU), Unité Mixte de Service Production et Analyse de données en Sciences de la vie et en Santé (PASS), and Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM)

Subjects
Male, Time Factors, MESH: Registries, health care facilities, manpower, and services, [SDV]Life Sciences [q-bio], medicine.medical_treatment, Cardiac rehabilitation, 030204 cardiovascular system & hematology, MESH: Risk Assessment, MESH: Aged, 80 and over, 0302 clinical medicine, Risk Factors, MESH: Risk Factors, Medicine, Registries, MESH: Cardiac Rehabilitation, 030212 general & internal medicine, Myocardial infarction, Atherothrombotic risk stratification, Non-ST Elevated Myocardial Infarction, health care economics and organizations, Cancer, MESH: Treatment Outcome, Aged, 80 and over, MESH: Aged, education.field_of_study, MESH: Middle Aged, Framingham Risk Score, Rehabilitation, nephrotic syndrome, MESH: Polymorphism, Single Nucleotide, Hazard ratio, Score, genetic renal disease, General Medicine, Middle Aged, MESH: Recovery of Function, 3. Good health, In-hospital mortality, Treatment Outcome, Stratification risque athérothrombotique, cardiovascular system, Female, France, Cardiology and Cardiovascular Medicine, medicine.medical_specialty, pediatrics, education, Population, Infarctus du myocarde, Acute myocardial infarction, Mortalité, MESH: Phenotype, Risk Assessment, 03 medical and health sciences, Intensive care, Internal medicine, MESH: Spain, Humans, cardiovascular diseases, Mortality, Réadaptation cardiaque, MESH: ST Elevation Myocardial Infarction, Medical prescription, Aged, focal segmental glomerulosclerosis, genome-wide association study, MESH: Humans, business.industry, MESH: Time Factors, MESH: Italy, Recovery of Function, medicine.disease, MESH: Male, MESH: Quantitative Trait Loci, MESH: Steroids, Confidence interval, MESH: France, MESH: Non-ST Elevated Myocardial Infarction, gene expression, Mortalité hospitalière, ST Elevation Myocardial Infarction, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, MESH: Nephrotic Syndrome, business, MESH: Female
Abstract

Cardiac rehabilitation is strongly recommended in patients after acute myocardial infarction.To assess cardiac rehabilitation prescription after acute myocardial infarction according to predicted risk, and its association with 1-year mortality, using the FAST-MI registries.We used data from three 1-month French nationwide registries, conducted 5 years apart from 2005 to 2015, including 13130 patients with acute myocardial infarction admitted to coronary or intensive care units. Atherothrombotic risk stratification was performed using the Thrombolysis In Myocardial Infarction Risk Score for Secondary Prevention (TRS-2P). Patients were classified into three categories: Group 1 (low risk; no or one risk indicator; score of 0 or 1); Group 2 (intermediate risk; two risk indicators; score of 2); and Group 3 (high risk; at least three risk indicators; score of≥3).Among the 12291 patients, cardiac rehabilitation prescription was 43.6% (49.9% in Group 1; 43.0% in Group 2; 35.2% in Group 3). Using Cox multivariable analysis, cardiac rehabilitation prescription was associated with lower mortality at 1 year in the overall population (3.8% vs. 8.2%; hazard ratio [HR] 0.72, 95% confidence interval [CI] 0.61-0.85; P0.001). Cardiac rehabilitation was associated with improved 1-year mortality, with homogeneous relative risk reductions in low- and intermediate-risk categories (HR 0.70, 95% CI 0.51-0.94) compared with high-risk patients (HR 0.72, 95% CI 0.59-0.88). In absolute terms, however, mortality decrease associated with cardiac rehabilitation was positively correlated with risk level (Group 1, 0.9% vs. 2.4%; Group 2, 3.0% vs. 4.2%; Group 3, 10.5% vs. 17.3%).Cardiac rehabilitation prescription was inversely correlated with patient risk. A positive association between cardiac rehabilitation and 1-year survival after acute myocardial infarction was present whatever the risk level, but the greatest mortality reduction was observed in high-risk patients.

Published
2019

32. 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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34. 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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37. 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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39. 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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40. 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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43. 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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44. Predicting CYP3A-mediated midazolam metabolism in critically ill neonates, infants, children and adults with inflammation and organ failure

Author

Brussee, J.M., Vet, N.J., Krekels, Elke H.J., Valkenburg, Abraham J., Jacqz-Aigrain, Evelyne, Gerven, Joop M.A. van, Wildt, S.N. de, Knibbe, C.A., Brussee, J.M., Vet, N.J., Krekels, Elke H.J., Valkenburg, Abraham J., Jacqz-Aigrain, Evelyne, Gerven, Joop M.A. van, Wildt, S.N. de, and Knibbe, C.A.

Abstract

Contains fulltext : 190055.pdf (publisher's version ) (Open Access)

Published
2018

46. 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

47. 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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48. 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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49. 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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