CTRI

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CTRI Number

CTRI/2020/05/025440 [Registered on: 29/05/2020] Trial Registered Prospectively

Last Modified On:

11/11/2020

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Screening
Process of Care Changes

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

A study to check if C-Reactive Protein is needed before stopping antibiotics in newborn babies suspected to have bacterial infection whose blood cultures are negative

Scientific Title of Study

A randomised controlled trial comparing safety and efficacy of short course versus CRP guided antibiotic regimen for blood culture negative suspected neonatal sepsis

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Abhijit Nanda
Designation	PG Registrar Pediatrics
Affiliation	Christian Medical College Vellore
Address	Department of Neonatology CMC Hospital Vellore 632004 Tamil Nadu Vellore TAMIL NADU 632004 India
Phone	7508354748
Fax
Email	anabhijit7@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Santhanam Sridhar
Designation	Professor and Head of Department of Neonatology CMC Vellore
Affiliation	Christian Medical College Vellore
Address	Department of Neonatology CMC Hospital Vellore 632004 Tamil Nadu Vellore TAMIL NADU 632004 India
Phone
Fax
Email	santhanamsridhar@gmail.com

Details of Contact Person
Public Query

Name	Dr Santhanam Sridhar
Designation	Professor and Head of Department of Neonatology CMC Vellore
Affiliation	Christian Medical College Vellore
Address	Department of Neonatology CMC Hospital Vellore 632004 Tamil Nadu Vellore TAMIL NADU 632004 India
Phone
Fax
Email	santhanamsridhar@gmail.com

Source of Monetary or Material Support

Institutional Fluid Research Grant

Primary Sponsor

Name	CMC hospital Vellore
Address	Office of the Treasurer Accounts Department Christian Medical College Vellore 632004
Type of Sponsor	Private medical college

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Abhijit Nanda	Christian Medical College Vellore	Level 2 nursery Department of Neonatology Christian Medical College Vellore Vellore TAMIL NADU	07508354748 anabhijit7@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Review Board, Christian Medical College, Vellore	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: R688\|\|Other general symptoms and signs,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Blood culture guided antibiotics duration	The first Arm will include new born babies with suspected sepsis whose blood culture will be done and antibiotics will be given for a duration of two to three days and stopped after the blood culture is reported negative that is on day two to day three.
Comparator Agent	C reactive Protein guided antibiotic duration	The second arm will include new born babies with suspected sepsis whose blood culture will be done and started on antibiotics but on day two to day three an additional test that is C Reactive Protein will be done and antibiotics will be either continued if C Reactive Protein is more than ten milligram per litre or stopped if C Reactive Protein is less than ten milligram per litre

Inclusion Criteria

Age From	0.00 Day(s)
Age To	1.00 Month(s)
Gender	Both
Details	1 Symptoms criteria a Apnea b Hyperthermia c Respiratory distress d Poor feeding e Lethargy f Irritability g Hypothermia h Hypotension i Poor perfusion j vomiting k Feed intolerance l Diarrhea m Seizures n Cyanosis 2 Laboratory criteria a Have a total WBC count more than 5000 per cubic millimeter b Have an Absolute Neutrophil Count more than 1500 per cubic millimeter 3 Baby becomes asymptomatic and are clinically well within 24 hours of suspicion of sepsis with following criteria a Normal activity b Stable temperature c Stable hemodynamic status with no need for inotropes d No respiratory support needed like supplementary oxygen CPAP ventilation

ExclusionCriteria

Details

1 They have received antibiotics in the past 15 days
2 They have had surgery in the past 7 days
3 Total WBC count less than 5000 per cubic millimeter
4 Have an Absolute Neutrophil Count less than 1500 per cubic millimeter
5 Abnormal activity beyond 24 hours of suspicion of sepsis
6 Unstable temperature beyond 24 hours of suspicion of sepsis
7 Unstable hemodynamic status requiring inotropes
8 Respiratory support needed like supplementary oxygen CPAP ventilation

Method of Generating Random Sequence

Permuted block randomization, variable

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Not Applicable

Primary Outcome

Outcome

TimePoints

All babies will be clinically reviewed 15 days after stopping antibiotics to look for any evidence of suspected sepsis

Rates of restarting antibiotics for suspected sepsis within 15 days of stopping antibiotics in the two groups will be compared

If babies have been discharged then this will be done over the phone with parents
This will be also done in Out Patient Department for babies discharged or in the ward if still admitted

15 days after stopping antibiotics

Secondary Outcome

Outcome	TimePoints
Duration of antibiotic therapy Incidence of necrotizing enterocolitis within 28 days of stopping antibiotics Rates of restarting antibiotics for suspected sepsis within 28 days of stopping antibiotics In babies who are well and discharged then a phone call will be made at 28 days to check for any symptoms of sepsis or necrotizing enterocolitis	28 days after stopping antibiotics

Target Sample Size

Total Sample Size="220"
Sample Size from India="220"
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)

01/06/2020

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="2"
Months="0"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Open to Recruitment

Publication Details

Nil

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Brief Summary

Sepsis is a common cause of morbidity and mortality in the neonatal period. As progression from initial symptoms to complications like shock, bleeding, cardio-respiratory failure can be rapid, many neonates are started on empirical antibiotics when they have a variety of symptoms of suspected sepsis after a sepsis screen.

Stopping antibiotics if blood culture is negative and baby is well is sometimes challenging. Many clinicians do a C Reactive Protein to decide if it is safe to stop antibiotics in this setting. However as C Reactive Protein can be falsely positive, there can be prolongation of antibiotic usage. Studies have shown that longer antibiotic usage can cause complications. Retrospective studies in very-low birth babies have shown higher mortality and Necrotising Enterocolitis in babies who have received more than 5 days antibiotics.

We propose that if sepsis screen is negative and the baby is well after 24 hours, antibiotics can be stopped if blood culture is negative. Neonates with suspected sepsis will be eligible for the trial if they become asymptomatic within 24 hours of starting antibiotics and fulfill inclusion and exclusion criteria. They will be randomized to either having a C Reactive protein done or no further testing. For the group that has no further testing, antibiotics will be stopped if blood culture is negative at 72 hours. For the group that has C Reactive protein done, antibiotics will be stopped when c Reactive protein is negative. Symptoms of sepsis will be monitored at 15 and 28 days after onset of initial symptoms.