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CTRI Number  CTRI/2013/07/003850 [Registered on: 29/07/2013] Trial Registered Retrospectively
Last Modified On: 29/12/2017
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Study of blood level of lifesaving antibiotic meropenum in serious ICU patients in relation to blood level that kills bacteria.  
Scientific Title of Study   A prospective pharmacokinetics and dose optimization study of extended infusion of Meropenem in adult critically ill cancer patients” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr J V Divatia 
Designation  Professor and Head 
Affiliation  Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital 
Address  Dr. E. Borges Marg
Parel
Mumbai
MAHARASHTRA
400012
India 
Phone  02224177041  
Fax  02224146937  
Email  jdivatia@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr J V Divatia 
Designation  Professor and Head 
Affiliation  Department of Anesthesia, Critical Care and Pain, Tata Memorial Centre  
Address  Dr. E. Borges Marg
Parel
Mumbai
MAHARASHTRA
400012
India 
Phone  02224177041  
Fax  02224146937  
Email  jdivatia@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr J V Divatia 
Designation  Professor and Head 
Affiliation  Department of Anesthesia, Critical Care and Pain, Tata Memorial Centre 
Address  Dr. E. Borges Marg
Parel
Mumbai
MAHARASHTRA
400012
India 
Phone  02224177041  
Fax  02224146937  
Email  jdivatia@yahoo.com  
 
Source of Monetary or Material Support  
Tata memorial Hospital 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Tata Memorial Centre Dr. E. Borges Marg Parel Mumbai 400012 Maharashtra, India 
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 = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vikram Gota  Dr. Gota Laboratory, Clinical Pharmacology, ACTREC  Advanced Centre for Training, Research and Education in Cancer, Tata Memorial Centre, Kharghar, Navi Mumbai Pin 410210
Raigarh
MAHARASHTRA 		 02227405130

vgota@actrec.gov.in 
Dr Amol Kothekar  Intensive Care Unit, Tata Memorial Hospital  Department of Anaesthesia, Critical Care and Pain Dr. E. borges Marg Parel Mumbai 400012
Mumbai
MAHARASHTRA 		 9323932058

amolkothekar@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
irb tmc  Approved 
irb tmc  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  critically ill patients in ICU,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Inclusion criteria
• Adult critically ill patients
• Age 18 yr to 70 yrs
• Known or suspected sepsis.
• Baseline plasma creatinine concentration within upper limit of normal
• Meropenem (MEROMER®) therapy initiated in ICU and expected to be continued for at least 3 days
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
T1. Peak plasma meropenem level
1. fT (Time duration for which plasma concentration is above MIC)
2. Proportion of patients with fT 40% of dosing interval.
3. Pharmacokinetics parameters including AUC, Cmax, Tmax, Volume of Distribution (Vd), Half-life (T1/2), Clearance (Cl) and elimination rate constant (Kel)
4. Time to MIC after first dose
 		 time zero, 5 min, 15 min, 30 min, and 1, 1.5, 2, 3, 4, 5, 6 and 8 h after the first dose of meropenum 
 
Secondary Outcome  
Outcome  TimePoints 
1. Pharmacokinetics parameters including AUC, Cmax, Tmax, Volume of Distribution (Vd), Half-life (T1/2), Clearance (Cl) and elimination rate constant (Kel)
2. Time to MIC after first dose
 		 time zero, 5 min, 15 min, 30 min, and 1, 1.5, 2, 3, 4, 5, 6 and 8 h after the first dose of meropenum 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
Final Enrollment numbers achieved (Total)= "25"
Final Enrollment numbers achieved (India)="25" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/06/2013 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not applicable 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Meropenem is a broad spectrum antibiotic belonging to carbapenem group. Meropenem is used as empirical therapy in severe sepsis to cover gram negative bacilli. Meropenem is a time-dependent antibiotic, whose antibacterial activity is related to the ‘time for which the free concentration is maintained above the MIC during a dosing interval’ (f T >MIC).  The f T>MIC required for optimal bactericidal activity for carbapenems has been reported to be 40% . Presently in TMH ICU Meropenem is routinely given as an infusion over 3 hours. However plasma meropenem levels achieved in critically ill septic patients might be variable due to pharmacokinetic changes in sepsis.

This study is designed to determine whether  the current dosing strategy of Meropenem is achieving

·         Meropenem plasma level > MIC (2 microgram/ ml) for intermediate Enterobacteriaceae GNB’s

·         Meropenem concentration above MIC for more than 40% of times between two doses. (fT>MIC of 40%)

We will also determine whether the levels achieved with this strategy will inhibit sensitive and intermediate strains of non lactose fermenter GNB’s like acinetobacter and pseudomonas.

25 consecutive patients meeting inclusion and exclusion criteria will be enrolled. Plasma Meropenem concentration will be determined using a validated reverse phase  HPLC assay.

 
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