Meropenem vs standard of care for treatment of late onset sepsis in children of less than 90 days of age: study protocol for a randomised controlled trial

Autor: Lutsar, I, Trafojer, Um, Heath, Pt, Metsvaht, T, Standing, J, Esposito, S, de Cabre VM, Oeser, C, Aboulker, Jp, Giaquinto, Carlo, the NeoMero Consortium
Přispěvatelé: Giaquinto, Carlo, Rossi, Paolo, Sharland, Mike, Heininger, Ulrich, Roilides, Emmanuel, Warris, Adilia, Usonis, Vytautas, Omeñaca Terés, Félix, Ceci, Adriana, Institute of Microbiology, University of Tartu, Neonatal Intensive Care Unit, Department of pediatrics, Division of Clinical Sciences, Queen Mary University of London (QMUL)-St George's, Clinic of Anaesthesiology and Intensive Care, University Clinics of Tartu, Infectious Diseases and Microbiology Unit, University College of London [London] (UCL), Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico, Essais Therapeutiques et Infection Par Le Vih, Université Paris-Sud - Paris 11 (UP11)-Institut National de la Santé et de la Recherche Médicale (INSERM), JFS is supported by a Methodology Fellowship G1002305 from the UK Medical Research Council. IL and TM are partly supported by the grants of Estonian Science Foundation (8799) and Estonian Target Financing (SF0182726s06) and from the European Union through the European Regional Development Fund and the Archimedes Foundation, NeoMero Consortium, European Project: 242146,EC:FP7:HEALTH,FP7-HEALTH-2009-single-stage,NEOMERO(2010), Institute of Child Health University College London, BMC, Ed., European multicenter network to evaluate pharmacokinetics, safety and efficacy of Meropenem in neonatal sepsis and meningitis - NEOMERO - - EC:FP7:HEALTH2010-01-01 - 2015-06-30 - 242146 - VALID
Jazyk: angličtina
Rok vydání: 2011
Předmět:
Pediatrics
medicine.medical_specialty
Neonatal intensive care unit
Population
Medicine (miscellaneous)
Meropenem
law.invention
Sepsis
Study Protocol
03 medical and health sciences
premature neonate
0302 clinical medicine
Clinical Protocols
Randomized controlled trial
law
030225 pediatrics
medicine
Clinical endpoint
Humans
Pharmacology (medical)
education
FP7
0303 health sciences
education.field_of_study
lcsh:R5-920
Neonatal sepsis
030306 microbiology
business.industry
Infant
Newborn
Postmenstrual Age
Infant
Length of Stay
medicine.disease
Anti-Bacterial Agents
3. Good health
[SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie
Thienamycins
[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie
neonate
business
lcsh:Medicine (General)
randomised controlled trial
medicine.drug
neonatal
sepsis
therapy
Zdroj: Trials, Vol 12, Iss 1, p 215 (2011)
Trials, London : BioMed Central Ltd, 2011, Vol. 12, art. no. 215, [9 p.]
Trials; Vol 12
Trials
Trials, 2011, 12 (1), pp.215. ⟨10.1186/1745-6215-12-215⟩
Trials, BioMed Central, 2011, 12 (1), pp.215. ⟨10.1186/1745-6215-12-215⟩
ISSN: 1745-6215
Popis: International audience; ABSTRACT: BACKGROUND: Late onset neonatal sepsis (LOS) with the mortality of 17 to 27% is still a serious disease. Meropenem is an antibiotic with wide antibacterial coverage. The advantage of it over standard of care could be its wider antibacterial coverage and thus the use of mono- instead of combination therapy. METHODS: NeoMero1, an open label, randomised, comparator controlled, superiority trial aims to compare the efficacy of meropenem with a predefined standard of care (ampicillin plus gentamicin or cefotaxime plus gentamicin) in the treatment of LOS in neonates and infants aged less than 90 days admitted to a neonatal intensive care unit. A total of 550 subjects will be recruited following a 1:1 randomisation scheme. The trial includes patients with culture confirmed (at least one positive culture from normally sterile site except coagulase negative staphylococci in addition to one clinical or laboratory criterion) or clinical sepsis (at least two laboratory and two clinical criteria suggestive of LOS in subjects with postmenstrual age less than 44 weeks or fulfilment of criteria established by the International Pediatric Sepsis Consensus Conference in subjects with postmenstrual age [greater than or equal to] 44 weeks). Meropenem will be given at a dose of 20 mg/kg q12h or q8h depending on the gestational- and postnatal age. Comparator agents are administered as indicated in British National Formulary for Children. The primary endpoint measured at the test of cure visit (2 days after end of study therapy) and is graded to success (all baseline symptoms and laboratory parameters are resolved or improved with no need to continue antibiotics and the baseline microorganisms are eradicated and no new microorganisms are identified and the patient has received allocated treatment for 11 plus/minus 3 days with no modification) or a failure (all remaining cases). Secondary outcome measures include comparison of survival, relapse rates or new infections by Day 28, clinical response at Day 3 and end of therapy, duration of hospitalisation, population pharmacokinetic analysis of meropenem and effect of antibiotics on mucosal colonisation and development of antibacterial resistance. The study will start recruitment in September 2011; the total duration is of 24 months. Trial registration: EudraCT 2011-001515-31.
Databáze: OpenAIRE
Externí odkaz: