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CTRI Number  CTRI/2023/08/056272 [Registered on: 08/08/2023] Trial Registered Prospectively
Last Modified On: 04/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Choice of antibiotics for the treatment of infection in newborn babies 
Scientific Title of Study   Comparision of Levofloxacin and Amikacin versus Piperacillin-tazobactam and Amikacin for the Treatment of Neonatal Sepsis: A 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  Ashok Kumar 
Designation  Professor 
Affiliation  Banaras Hindu University 
Address  Department of Pediatrics, Institute of Medical Sciences, Banaras Hindu University, Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  09415300370  
Fax    
Email  ashokkumar_bhu@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ashok Kumar 
Designation  Professor 
Affiliation  Banaras Hindu University 
Address  Department of Pediatrics, Institute of Medical Sciences, Banaras Hindu University, Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  09415300370  
Fax    
Email  ashokkumar_bhu@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Ayush Yadav 
Designation  Postgraduate Student 
Affiliation  Banaras Hindu University 
Address  Department of Pediatrics, Institute of Medical Sciences, Banaras Hindu University, Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  9415232932  
Fax    
Email  krishan154deo@gmail.com  
 
Source of Monetary or Material Support  
SS Hospital, Banaras Hindu University, Varanasi 
 
Primary Sponsor  
Name  Banaras Hindu University 
Address  Department of Pediatrics, Institute of Medical Sciences, Banaras Hindu University, Varanasi 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Prof Ashok Kumar  SS Hospital  Neonatology Unit, Third Floor, MCH Building, Department of Pediatrics
Varanasi
UTTAR PRADESH 		 09415300370

ashokkumar_bhu@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ECR/526/Inst/UP/2014/RR-2020  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  Injection Levofloxacin and Amikacin  Injection Levofloxacin and Amikacin will be administered to newborns with suspected or confirmed sepsis using standard doses adjusted to gestational age, birth weight, kidney function and postnatal age.Total duration of intervention will be 5-7 days for clinical sepsis , 10-14 days for culture positive sepsis and 21 days for meningitis 
Comparator Agent  Injection Piperacillin-Tazobactam and Amikacin  Injection Piperacillin-tazobactam and Amikacin will be administered to newborns with suspected or confirmed sepsis using standard doses adjusted to gestational age, birth weight, kidney function and postnatal age. Total duration of intervention will be 5-7 days for clinical sepsis , 10-14 days for culture positive sepsis and 21 days for meningitis 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  The diagnosis of neonatal sepsis will be based on the presence of the following criteria, as defined by the European Medicines Agency (2010). Per EMA criteria there should be at least 2 clinical and 2 laboratory signs for making a diagnosis of suspected or confirmed neonatal sepsis. These criteria are as follows:
Clinical symptoms (2 or more)
1. If core body temperature >38.5°C or <36°C or temperature instability.
2. Cardiovascular instability: Bradycardia, (heart rate <80/min), Tachycardia (heart rate >180/min), Rhythm instability, Reduced urine output (<1ml/kg/hour), Hypotension requiring volume or inotropic support, Mottled skin, Capillary refilling time >3 seconds
3. Respiratory instability: Apnea (cessation of breathing for >20 seconds), Tachypnea (respiratory rate >60/min, Increased oxygen requirement >10%, Requirement of ventilatory support
4. Petechial rash or sclerema.
5. Feed intolerance or poor sucking or abdominal distension.
6. Central nervous system: Irritability, Lethargy, Hypotonia, Seizure
7. Cellulitis or skin ulceration.
8. Non-specific: irritability or lethargy or hypotonia
Laboratory signs (2 or more)
1. White blood cells (WBC) count <4,000/cubic mm or >20,000/cubic mm.
2. Platelet count <100,000/cubic mm
3. Immature to total neutrophil ratio >0.2
4. C-reactive protein >10 mg/L
5. Glucose intolerance confirmed at least 2 times: hyperglycemia (blood glucose >180 mg/dL or 10mmol/L) or hypoglycemia (blood glucose <45mg/dL or 2.5 mmol/L).
6. Metabolic acidosis: Base excess (BE) below -10 mEq/L or Serum lactate >2 mmol/L.
7. Chest X-ray suggestive of bronchopneumonia
8. Cerebrosinal fluid changes suggestive of septic meningitis.
 
 
ExclusionCriteria 
Details  1. Newborns receiving prophylactic antibiotics
2. Surgical conditions and life threatening congenital malformations
3. Failure to obtain consent
4. Prior exposure of antibiotics

 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Treatment failure defined as a need for changing initial antibiotics regimen within 72
hours or earlier if treating physician considers it
necessary in view of rapidly deteriorating clinical
condition of newborn or patient not cured by 7 days after enrollment. 		 7 days 
 
Secondary Outcome  
Outcome  TimePoints 
1. Mortality during hospitalization
2. Adverse effects of therapy
3. Duration of hospitalization 		 During hospitalization 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
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)   15/08/2023 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ashokkumar_bhu@hotmail.com].

  6. For how long will this data be available start date provided 24-06-2025 and end date provided 24-06-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Generally, ampicillin and gentamicin are recommended as initial antibiotic regimen to treat neonatal sepsis. However, due to emerging antimicrobial resistance, it is becoming increasingly difficult to treat neonatal sepsis. This has led to the search for alternative antibiotics which are effective.  It is common practice to use piperacillin-tazobactam and amikacin combination to treat neonatal sepsis. However, resistance has also been reported to this combination of antibiotics. In our unit many bacterial isolates are sensitive to levofloxacin. However, no study has been done on the comparative effectiveness and safety of piperacillin-tazobactam and amikacin versus levofloxacin and amikacin. The diagnosis pf neonatal sepsis will be considered as per EMA 2010 criteria. Sepsis work-up will include CBC, CRP, blood culture and culture from other sterile body sites whenever indicated and feasible.Other relevant investigations such as chest x-ray, ABG, renal and liver function tests, coagulogram, cranial sonography, echocardiography will be done as per need. Lumbar puncture will be done if there is strong suspicion of septic meningitis such as seizures, bulging anterior fontanelle. and altered sensorium. We generally perform LP in late onset sepsis and those with positive blood culture unless baby is otherwise well and showing good recovery. LP will delayed for 24-48 hours in hemodynamically unstable neonates. Detailed clinical and laboratory data will be recorded on a predesigned proforma. Complications will be managed as per our unit protocol. The duration of antibiotics will be 5-7 days for clinical sepsis, 10-14 days for culture positive sepsis and 21 days in case of meningitis. We generally do not repeat LP at the completion of therapy.  
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