CTRI/2026/01/101199尚未招募Phase 3 4
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: NeoSep1
Global Antibiotic Research and Development Partnership (GARDP)3 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2026年1月27日最近更新:
适应症
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 3,000
- 试验地点
- 3
- 主要终点
- 28-day mortality
研究概览
简要总结
The NeoSep1 study is investigating new antibiotic combinations to treat newborns (28 days old or younger) hospitalized with severe sepsis. Due to rising antibiotic resistance, current treatments are becoming less effective. The study will compare three two-drug combinations—fosfomycin plus amikacin, flomoxef plus amikacin, and fosfomycin plus flomoxef against standard treatments used globally. These combinations were selected based on earlier research that determined safe and effective doses for newborns. The goal is to find better treatment options while minimizing the risk of increasing antibiotic resistance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Day(s) 至 28.00 Day(s)（—）
- 性别
- All
入选标准
- •Currently admitted to hospital
- •Aged less than or equal to 28 days (post-natal age)
- •Weight greater than or equal to 1000gram
- •Clinical diagnosis of a new episode of sepsis with two or more of the following clinical signs together with planned treatment with IV antibiotics a.
- •Abnormal temperature (less than 35.5 degree Celsius Or greater than or equal to 38degree celsius) b.
- •Chest indrawing or increase in oxygen requirement or increase of respiratory support c.
- •Abdominal distension d.
- •Difficulty in feeding or feeding intolerance e.
- •Lethargy, or reduced or no spontaneous movement g.
- •Cyanosis h.
- •Abnormal heart rate (bradycardia less than 80 Beats Per Minute; tachycardia greater than 80 Beats Per Minute) i.
- •Convulsions j.
- •Irritability For making the diagnosis of significant sepsis, the neonate should have no alternative primary explanation for these criteria (such as Hypoxic Ischaemic Encephalopathy, hypothermia, hypoglycemia, prematurity etc)
- •At moderate to high risk of death from this episode of sepsis, based on a neonatal sepsis severity score (NeoSep Severity Score).
- •This was adapted from the WHO Possible serious bacterial infection based scores for the hospital setting and developed using baseline clinical information and subsequent mortality from the Neonatal observational study study; specifically, a NeoSep Severity Score of 5 or higher at presentation for this episode of sepsis (which may be before formal screening)
- •Can receive all potential treatment options on the relevant randomisation list for this neonate at their site, ensuring randomisation is possible see country-specific appendices
- •Intravenous antibiotics about to be started OR not received more than 24 hours of Intravenous antibiotics for this episode of neonatal sepsis at the point of randomisation
- •Parent or guardian willing and able to provide consent (written or, if their neonate is severely ill, verbal consent which must be confirmed by written consent as soon as possible and wherever possible within 48 hours after the first trial specific procedure).
- •Verbal consent allows for administration of first-line antibiotics at no or minimal delay.
排除标准
- •A known serious, non-infective co-morbidity anticipated to cause death within this admission (including major congenital abnormalities anticipated to cause death within this admission other than prematurity, e.g. known large ventricular septal defect)
- •Previously enrolled in this trial
- •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)
- •Known contraindication to any of the trial antibiotics on the randomisation list for the relevant neonatal sub-population in that site.
结局指标
主要结局
28-day mortality
时间窗: Baseline to Day 28
次要结局
- Clinical status, assessed daily after randomisation through to the earlier of discharge from a trial site or Day 28 using a clinical recovery score based on data from the NeoOBS observational study(Baseline to Day 28)
- Additional systemic antibiotics beyond the first randomised treatment through Day 28(Baseline to Day 28)
- Additional systemic antibiotics beyond the first randomised and second (for failure) treatment through Day 28(Baseline to Day 28)
- Length of stay during the index hospitalisation(Baseline to Day 28)
- Systemic antibiotic exposure (days on antibiotics) during the index hospitalisation(Baseline to Day 28)
- 90-day mortality(Day 29 to Day 90)
- Change in C-reactive protein to Day 3 and 7 from baseline(Baseline to Day 3 and day 7)
- Grade 3/4 adverse events (AEs) graded using a combined low and middle income country (LMIC) relevant adapted Division of AIDS (DAIDS) and International Neonatal Consortium Neonatal Adverse Event Severity Scale (NAESS) through Day 28(Baseline to Day 28)
- Adverse events of any grade related to antibiotics through Day 28(Baseline to Day 28)
- Modification (including discontinuation) of antibiotics for adverse reactions through Day 28(Baseline to Day 28)
- Neurodevelopment as assessed by the WHO Global Scale for Early Development (GSED) package at Day 28 and Day 90(Day 28 and Day 90)
- Re-admission by Day 90 (all-cause)(Discharge to Day 90)
研究者
研究点 (3)
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