An open-label randomised controlled trial comparing novel combination and existing antibiotic regimens for the empiric treatment of neonatal sepsis with a run-in confirmatory pharmacokinetic phase (NeoSep1)

Global Antibiotic Research & Development Partnership0 个研究点目标入组 3,060 人开始时间: 2022年2月24日最近更新: 2024年6月24日

适应症

试验速览

2024 Poster results see attached file ISRCTN48721236 NeoSEP Part1 results ESPID poster_30Apr24.pdf Part 1 results (added 10/06/2024)

•1. Currently admitted to hospital
•2. Aged =28 days (post-natal age)
•3. Weight >1000 g
•4. Clinical diagnosis of a new episode of sepsis together with planned treatment with IV antibiotics
•5. At moderate to high risk of death from this episode of sepsis, based on a neonatal sepsis severity score (NeoSep Severity Score) developed using baseline clinical information and subsequent mortality from the NeoOBS study; specifically, a baseline assessment NeoSep Severity Score of 4 or higher
•6. Can receive at least 2 of the potential treatment options, ensuring randomisation is possible (Part 2 only)
•7. IV antibiotics about to be started or not received >24 h of IV antibiotics for this episode of neonatal sepsis at the point of randomisation
•8. Parent/guardian willing and able to provide consent (written or, if their baby is severely ill, verbal consent confirmed by written consent as soon as possible). Verbal consent allows for the administration of first-line antibiotics at no or minimal delay.

•1. A serious, non-infective co-morbidity including major congenital abnormalities (other than prematurity), anticipated to cause death within this admission
•2. Previously enrolled in this trial
•3. Current participation in any other clinical study of an Investigational Medicinal Product (IMP) that is a systemic drug, unless it has received prior approval by the NeoSep1 Trial Management Group (TMG)
•4. Known contraindication to any of the trial antibiotics on the randomisation list for the relevant neonatal sub-population in that site

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