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CTRI Number  CTRI/2025/10/096008 [Registered on: 13/10/2025] Trial Registered Prospectively
Last Modified On: 13/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Checking the difference in usefulness and cost of two ways of giving meropenem medicine to cancer child patients with fever and low immunity 
Scientific Title of Study   Therapeutic and pharmacoeconomic comparison of 24-hours continuous infusion versus 2-hours intermittent infusion of meropenem in paediatric febrile neutropenia patients: 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  Prof Dr M S Ganachari 
Designation  Head of the Department, Department of Pharmacy Practice, KLE College of Pharmacy, Belagavi 
Affiliation  KLE College of Pharmacy Belagavi 
Address  KLE Academy of Higher Education and Research Nehru Nagar Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9448634457  
Fax    
Email  msganachari@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Abhilasha S 
Designation  Professor 
Affiliation  KLE Academy of Higher Education and Research Nehru Nagar Belagavi-590010 
Address  KLE Academy of Higher Education and Research Nehru Nagar Belagavi

Belgaum
KARNATAKA
590010
India 
Phone    
Fax    
Email  abhilasha.pedia@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ashwini Doddannavar 
Designation  Assistant Professor 
Affiliation  KLE Academy of Higher Education and Research Nehru Nagar Belagavi-590010 
Address  KLE Academy of Higher Education and Research Nehru Nagar Belagavi

Belgaum
KARNATAKA
590010
India 
Phone    
Fax    
Email  ashwinidoddannavar4@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr M S Ganachari 
Address  KLE College of Pharmacy Belagavi 
Type of Sponsor  Research institution and hospital 
 
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 
Prof Dr M S Ganachari  KLE Cancer Hospital, KLEs Dr Prabhakar Kore Hospital & Medical Research Centre Belagavi  Department of Pharmacy Practice, division of pediatric Oncology.
Belgaum
KARNATAKA 		 9448634457

msganachari@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KLECOPBGM ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms, (2) ICD-10 Condition: D50-D89||Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Continuous infusion  Group A (Continuous Infusion Group): Patients will receive meropenem at 60–120 mg/kg/day (up to a maximum of 3 g/day) as a 24-hour continuous infusion. The duration of therapy will range from 7 to 14 days.  
Comparator Agent  Intermittent infusion  Group B (Intermittent Infusion Group): Patients will receive meropenem at 120 mg/kg/day (up to a maximum of 3 g/day), administered as 2-hour infusions of 3 doses every 8 hours, and will be administered for 7 to 14 days. 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1. All paediatric patients aged below 18 years, diagnosed with any type of cancer.
2. Patients undergoing chemotherapy for both haematological malignancies and solid
tumours.
3. Absolute neutrophil count (ANC) less than 500 cells per microlitre.
4. Patients who have a documented fever of more than or equal to 38.3°C (101°F) or more than or equal to 38°C (100.4°F) for
more than one hour, unrelated to administration of blood products or pyrogenic
substances.
5. Informed consent obtained from parents or guardians.
6. Prescribed meropenem administered either as a 24-hour continuous infusion or as a 2
hour intermittent infusion.  
 
ExclusionCriteria 
Details  1. Patients who refuse to provide informed consent by parent or legal guardian.
2. Prior or ongoing treatment with carbapenems or multiple broad-spectrum antibiotics
before enrolment.
3. Known hypersensitivity or allergic reaction to meropenem or other carbapenem-class
antibiotics.
4. Presence of severe renal or hepatic dysfunction, as determined by the treating
physician.
5. Patients undergoing chemo-radiotherapy with bone marrow or peripheral stem cell
transplantation. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The primary outcome would be to monitor the duration of fever resolution and also the duration of neutropenia.  Within 7 days of starting therapy 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcome would be to assess the duration of hospitalization & to evaluate the mortality & survival rates.  During treatment period from day 0 to day 30 
To record any adverse effects associated with the use of antibiotics & to track the development of any resistant bacterial strains in the study population.   During treatment period till day 30 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   25/10/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
Febrile neutropenia (FN) is a frequent and serious complication in paediatric cancer patients receiving chemotherapy. Prompt administration of broad-spectrum antibiotics such as meropenem is critical to reduce morbidity and mortality. Emerging pharmacodynamic evidence indicates that extended or continuous infusion of meropenem may improve drug exposure (time above MIC), optimise clinical outcomes and limit resistance compared to standard intermittent infusion. However, current literature on paediatric data in resource-limited settings is inadequate to guide robust conclusions.

This single-centre, randomised controlled trial will compare 24-hour continuous infusion with 2-hour intermittent infusion of meropenem in paediatric patients with FN. Eligible participants will be randomised in a 1:1 ratio to either intervention arm. The primary endpoint is time to fever resolution. Secondary outcomes include duration of hospitalisation, clinical success rate, all-cause mortality, emergence of resistance, and cost of therapy. Microbiological evaluation will include culture and sensitivity testing with determination of minimum inhibitory concentration (MIC) for meropenem within 48 hours and on Day 5 of therapy to monitor susceptibility trends.

The findings of this trial are expected to provide evidence on the comparative effectiveness and cost-efficiency of meropenem infusion strategies in paediatric FN, support rational antibiotic use and contribute to antimicrobial stewardship practices in paediatric oncology settings.
 
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