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

Trials

The NeoMero Consortium¹  Jean-Pierre Aboulker⁷  Clarissa Oeser²  Vincent Meiffredy de Cabre⁷  Susanna Esposito⁵  Joseph Standing⁶  Tuuli Metsvaht⁸  Paul T Heath²  Ursula MT Trafojer⁴  Irja Lutsar³ 

[1]Via Giustiniani 3, 35128, Padova, Italy

[2]Division of Clinical Sciences, St George's, University of London, Cranmer Terrace, Londo, SW17 0RE, UK

[3]Institute of Microbiology, University of Tartu, Ravila 19, Tartu, 50411, Estonia

[4]Neonatal Intensive Care Unit, Department of Pediatrics, Via Giustiniani 3, Padova, 35128, Italy

[5]Department of Maternal and Pediatric Sciences, Università degli Studi di Milano, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Via Commenda 9, Milano, 20122, Italy

[6]Infectious Diseases and Microbiology Unit, Institute of Child Health University College London, 30 Guilford Street, London, WC1N 1EH, UK

[7]INSERM SC10, 16, avenue Paul-Vaillant Couturier, Villejuif, 94807, France

[8]Clinic of Anaesthesiology and Intensive Care, University Clinics of Tartu, Lunini 6, Tartu, 50411, Estonia

关键词: FP7;    premature neonate;    neonate;    randomised controlled trial;   

Others  :  1095840
DOI  :  10.1186/1745-6215-12-215

 received in 2011-07-18, accepted in 2011-09-30,  发布年份 2011

【 摘 要 】

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

NeoMero-1, an open label, randomised, comparator controlled, superiority trial aims to compare the efficacy of meropenem with a predefined standard of care (ampicillin + gentamicin or cefotaxime + 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 < 44 weeks or fulfilment of criteria established by the International Pediatric Sepsis Consensus Conference in subjects with postmenstrual age ≥ 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) 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 ± 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

【 授权许可】

   
2011 Lutsar et al; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

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