An open-label randomised controlled trial comparing novel combination and currently used antibiotic regimens for the empiric treatment of neonatal sepsis with a run-in confirmatory pharmacokinetic phase: NeoSep01

Global Antibiotic Research and Development Partnership GARDP0 个研究点目标入组 3,000 人开始时间: 2022年8月5日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•1. Currently admitted to hospital
•2. Aged =28 days (post-natal age)
•3. Weight =1000g
•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), adapted from the WHO PSBI based scores for the
•hospital setting and developed using baseline clinical information and subsequent mortality
•from the NeoOBS study as described in Table 5:5; specifically, a baseline assessment NeoSep
•Severity Score of 5 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 more than 24 hours 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
•administration of first-line antibiotics at no or minimal delay (see Section 4.5 for details)

•1. A known 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 (see Section 6; these will vary according to the
•antibiotics on the specific randomisation list

发起方

Global Antibiotic Research and Development Partnership GARDP