| CTRI Number |
CTRI/2024/08/072739 [Registered on: 20/08/2024] Trial Registered Prospectively |
| Last Modified On: |
15/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Shorter symptom based antibiotic course for early onset neonatal sepsis |
|
Scientific Title of Study
|
Fixed versus symptom based duration of antibiotics in probable Early onset neonatal sepsis An open label Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shiwani Thakur |
| Designation |
Senior Resident |
| Affiliation |
Government Medical College and Hospital |
| Address |
Department of Neonatology
Government Medical College and Hospital
Sector 32A, Chandigarh
PIN:160030
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9418669352 |
| Fax |
|
| Email |
shiwanithakur92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Supreet Khurana |
| Designation |
Assisstant Professor |
| Affiliation |
Government Medical College and Hospital |
| Address |
Department of Neonatology
Government Medical College and Hospital
Sector 32A, Chandigarh
PIN-160030
Chandigarh
CHANDIGARH
160030
India |
| Phone |
7087612359 |
| Fax |
|
| Email |
supreetkhurana85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shiwani Thakur |
| Designation |
Senior Resident |
| Affiliation |
Government Medical College and Hospital |
| Address |
Department of Neonatology
Government Medical College and Hospital
Sector 32A, Chandigarh
PIN:160030
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9418669352 |
| Fax |
|
| Email |
shiwanithakur92@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Hospital, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital |
| Address |
Department of Neonatology
Government Medical College and Hospital
Sector 32A, Chandigarh
PIN:160030
PIN:160030 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Shiwani Thakur |
DM senior resident, GMCH, Sec 32-A, Chandigarh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shiwani Thakur |
Government Medical College and Hospital |
Department of Neonatology
Sector 32A, Chandigarh
PIN:160030
Chandigarh
CHANDIGARH |
9418669352
shiwanithakur92@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE (GMCH, Chandigarh) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P369||Bacterial sepsis of newborn, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Drugs:
Ciprofloxacin or Ampicillin-Sulbactum and Amikacin |
Route,Dose and frequency:
1.Ciprofloxacin (Intravenous)- 15mg/kg/dose 12 hourly
2.Ampicillin/sulbactum (Intravenous)-50mg/kg/dose 8-12 hourly as per gestational age less than equal to or more than 34 weeks at births
3.Amikacin(Intravenous)-15mg/kg/dose 24 hourly
Duration- Till clinical resolution of symptoms has occured for atleast 24 hours. |
| Comparator Agent |
Drugs:
Ciprofloxacin or
Ampicillin-sulbactum and
Amikacin |
Dose,frequency and route:
1.Ciprofloxacin (Intravenous)-15mg/kg/dose 12 hourly
2.Ampicillin/sulbactum (Intravenous)-50mg/kg/dose, 8-12 hourly as per gestational age less than equal to or more than 34 weeks at births
3.Amikacin(Intravenous)-15mg/kg/dose ,24 hourly.
Duration:Antibiotics will be given for 5-7 days as per clinicians discretion. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Day(s) |
| Age To |
5.00 Day(s) |
| Gender |
Both |
| Details |
Inborn neonates with gestational age ≥ 32 week and birth weight ≥1500gm with maternal and neonatal factors at birth will be assessed for eligibility for persistence of symptoms at 48-72 hours and negative blood culture.
|
|
| ExclusionCriteria |
| Details |
Severe birth asphyxia, IVH, PICC/UVC,bleeding, meningitis, other sepsis trial |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Antibiotic utilization ratio for early onset sepsis |
At end of first week of life |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Clinical deterioration during
intervention period of 7 days
2.Total antibiotic utilization
ratio
3. Total sepsis episodes |
1.within 1 week of intervention
2.at the end of hospital stay (34-40 weeks corrected gestational age depending upon birth sickness & gestational age) |
|
|
Target Sample Size
|
Total Sample Size="156"
Sample Size from India="156"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Our study is planning to address this knowledge gap by comparing the symptom based course of antibiotics based upon symptom resolution in cases being managed as clinically suspected early onset sepsis in neonates versus fixed course of a minimum of 5-7 days. We shall be both looking at clinically relevant outcomes and comparing adverse events in both the groups.Among neonates with completed gestational age at birth ≥32 weeks and birth weight ≥1500gm with early onset neonatal sepsis (P), does symptom based course of antibiotics (I) in comparison to fixed course(C), reduces the antibiotic utilization ratio (O) in clinically suspected early onset sepsis during hospital stay. |