| CTRI Number |
CTRI/2026/01/101199 [Registered on: 15/01/2026] Trial Registered Prospectively |
| Last Modified On: |
19/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
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Type of Study
|
Drug |
| Study Design |
Other |
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Public Title of Study
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A trial comparing novel combination and currently used antibiotic regimens for the treatment of clinically diagnosed neonatal sepsis |
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Scientific Title of Study
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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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 48721236 |
ISRCTN |
| NeoSep1 Version 3.0 dated 03 Oct 2024 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Kanhaiya Choudhary |
| Designation |
Senior Director Clinical Services |
| Affiliation |
Novotech India Private Limited |
| Address |
Ground Floor, Unit 1, Block E, Helios Business Park, Kadubeesanahalli, Bangalore 560103 India
Bangalore
KARNATAKA
560103
India |
| Phone |
08045514402 |
| Fax |
08045514402 |
| Email |
kanhaiya.choudhary@novotech-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Kanhaiya Choudhary |
| Designation |
Senior Director Clinical Services |
| Affiliation |
Novotech India Private Limited |
| Address |
Ground Floor, Unit 1, Block E, Helios Business Park, Kadubeesanahalli, Bangalore 560103 India
Bangalore
KARNATAKA
560103
India |
| Phone |
08045514402 |
| Fax |
08045514402 |
| Email |
kanhaiya.choudhary@novotech-cro.com |
|
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Source of Monetary or Material Support
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| Global Antibiotic Research and Development Partnership (GARDP)
15 Chemin Camille-Vidart
1202 Geneva, Switzerland |
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Primary Sponsor
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| Name |
Global Antibiotic Research and Development Partnership (GARDP) |
| Address |
15 Chemin Camille-Vidart
1202 Geneva, Switzerland
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| Type of Sponsor |
Other [Not-for-profit research and development organization] |
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Details of Secondary Sponsor
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| Name |
Address |
| Novotech Clinical Research India Private Limited |
408, Level 4 East Patel Nagar, New Delhi,
New Delhi (India) - 110008 |
|
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Countries of Recruitment
|
Bangladesh
Ghana
India
Kenya
Pakistan
South Africa
Uganda
Viet Nam |
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Sites of Study
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| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nishad Plakkal |
Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER) |
Additional Professor and Head
Department of Neonatology
Room No. 5, 1st Floor, Women and Childrens Hospital
Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry 605006, India
Pondicherry
PONDICHERRY |
7708577133
plakkal@gmail.com |
| Dr Swati Manerkar |
Lokmanya Tilak Municipal College and General Hospital, |
Room No. 123, Department of Neonatology,
1st floor, College Building, LTMMC & GH, Sion, Mumbai - 400022
Mumbai
MAHARASHTRA |
97699 97968
ltmmcneo@gmail.com |
| DrJagjit Dalal |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS) |
Professor & Head of Department of Neonatology, Room no. 225 MCH building near labor, Pt B.D Sharma, PGIMS Rohtak Haryana - 124001
Rohtak
HARYANA |
99689 68980
jagjit.dr@gmail.com |
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Details of Ethics Committee
Modification(s)
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| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| IEC Intervention Studies (Human), JIPMER |
Approved |
| Institutional Ethics Committee Pt. B.D. Sharma Post Graduate Institute of Medical Sciences, UHS, Rohtak |
Approved |
| Institutional Ethics Committee, Lokmanya Tilak |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P369||Bacterial sepsis of newborn, unspecified, (2) ICD-10 Condition: A418||Other specified sepsis, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
Amikacin solution for Injection or Infusion
Flomoxef powder for Intravenous Injection
Fosfomycin: powder for solution for infusion
Ampicillin powder for solution for injection
Amoxicillin powder for solution for injection
Benzylpenicillin Sodium powder for solution for injection/infusion
Cefotaxime powder for solution for injection
Ceftazidime Powder for Solution for Injection or Infusion
Ceftriaxone Powder for Solution for Injection or Infusion
Cloxacillin Powder for Solution for Injection
Gentamicin Solution for Injection or Infusion
Meropenem Powder for Solution for Injection or Infusion
Piperacillin/Tazobactam powder for solution for infusion
All trial IMP except flomoxef and fosfomycin will be hospital stock and will be sourced locally by sites |
Flomoxef: Powder for solution for infusion(1g) in 10ml glass vial Fosfomycin:40 mg/ml powder for solution for infusion(2g) in 50 ml bottle. Neonate’s planned participation will be 90 days from randomisation |
| Comparator Agent |
NA |
NA |
|
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Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
1. Currently admitted to hospital
2. Aged less than or equal to 28 days (post-natal age)
3. Weight greater than or equal to 1000gram
4. 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. Evidence of shock including cold peripheries
f. 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)
5. 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)
6. 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
7. 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
8. 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.
|
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| ExclusionCriteria |
| Details |
1. 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)
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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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Centralized |
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Blinding/Masking
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Not Applicable |
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Primary Outcome
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| Outcome |
TimePoints |
| 28-day mortality |
Baseline to Day 28 |
|
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Secondary Outcome
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| Outcome |
TimePoints |
| 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 |
|
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Target Sample Size
|
Total Sample Size="3000"
Sample Size from India="600"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
27/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
06/06/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
|
Years="4"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
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. |