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CTRI Number  CTRI/2014/12/005297 [Registered on: 15/12/2014] Trial Registered Retrospectively
Last Modified On: 20/12/2017
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Antibacterial utilization study in patients admitted to medical intensive care unit of major hospital of india 
Scientific Title of Study   A multicentric, observational, prospective drug utilization study of antibacterial agents with special focus on vancomycin and colistin in patients admitted to the Medicine Intensive Care Units (MICU) of major hospitals 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Antibact_DUR_01_2013 version 2 dated 3 Feb 2014  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Urmila Thatte 
Designation  Professor and Head 
Affiliation  Seth GS Medical College and KEM Hospital 
Address  Department of Clinical Pharmacology 1st Floor 13th Floor Building Seth GS Medical College and KEM Hospital Mumbai
Department of Clinical Pharmacology 1st Floor 13th Floor Building Seth GS Medical College and KEM Hospital Mumbai
Mumbai
MAHARASHTRA
400012
India 
Phone  02224133767  
Fax  02224112871  
Email  urmilathatte@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Nitin Mali 
Designation  PhD Scholar 
Affiliation  Seth GS Medical College and KEM Hospital 
Address  Department of Clinical Pharmacology 1st Floor 13th Floor Building Seth GS Medical College and KEM Hospital Mumbai
Department of Clinical Pharmacology 1st Floor 13th Floor Building Seth GS Medical College and KEM Hospital Mumbai
Mumbai
MAHARASHTRA
400012
India 
Phone  02224133767  
Fax  02224112871  
Email  nitinbmali85@gmail.com  
 
Details of Contact Person
Public Query  
Name  Nitin Mali 
Designation  PhD Scholar 
Affiliation  Seth GS Medical College and KEM Hospital 
Address  Department of Clinical Pharmacology 1st Floor 13th Floor Building Seth GS Medical College and KEM Hospital Mumbai
Department of Clinical Pharmacology 1st Floor 13th Floor Building Seth GS Medical College and KEM Hospital Mumbai
Mumbai
MAHARASHTRA
400012
India 
Phone  02224133767  
Fax  02224112871  
Email  nitinbmali85@gmail.com  
 
Source of Monetary or Material Support  
Seth GS Medical College and KEM Hospital 
 
Primary Sponsor  
Name  Seth GS Medical College and KEM Hospital 
Address  Seth GS Medical College and KEM Hospital Dr Borges Road Near Tata Hospital Parel Mumbai 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sanjay Wagle  Bombay Hospital and Medical Research Centre  Department of Medicine Bombay Hospital and Medical Research Centre 12 New Marine Lines Mumbai 400020
Mumbai
MAHARASHTRA 		 02222091325

scwagle@gmail.com 
Dr Urmila Thatte  Seth GS Medical College and KEM Hospital  Department of Clinical Pharmacology Seth GSMC and KEM Hospital parel Mumbai
Mumbai
MAHARASHTRA 		 02224133767

urmilathatte@gmail.com 
Dr Kannan Sridharan  Subharti Medical College and Hospital  Department of Pharmacology Subharti Medical College and Hospital Subharti puram NH58 Delhi Haridwar Bypass Road Meerut
Meerut
UTTAR PRADESH 		 8192902803

skannandr@gmail.com 
Dr Renuka Munshi  T N Medical college and BYL Nair Charitable Hospital Mumbai Central Mumbai  Department of Clinical Pharmacology T N Medical college and BYL Nair Charitable Hospital Mumbai Central Mumbai
Mumbai
MAHARASHTRA 		 02223014713
02223050347
renuka.munshi@gmail.com 
Dr J V Divatia  Tata Memorial Hospital  Department of Anaesthesia Tata Memorial Hospital Dr.E Borges Marg Parel Mumbai 400012
Mumbai
MAHARASHTRA 		 02226231974
02224146937
jdivatia@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Bombay Hospital Ethics Committee  Approved 
Ethics Committee for Academic Research Project PG Academic Committee TN Medical College and BYL Nair Hospital  Approved 
Institutional Ethics Committee I Seth GS Medical College and KEM Hospital  Approved 
Institutional Ethics Committee Subharti Medical College and Hospital  Approved 
Institutional Ethics Committee Tata Memorial Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients admitted to Medicine Intensive Care Unit ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patients either gender of above 14 years old admitted to Medicine Intensive Care Unit  
 
ExclusionCriteria 
Details  Not willing to participate in the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Proportion of patients receiving either vancomycin or colistin or both
2. Prescribed daily dose (PDD) of antibacterial agents
3. Defined daily doses (DDDs) per 100 bed-days for individual antibacterial agents  		 All the outcomes will be assessed at the end of the study 
 
Secondary Outcome  
Outcome  TimePoints 
1. Proportion of antibacterial agents prescribed over the study period
2. To assess the proportion of antibacterials prescribed on the basis of culture and sensitivity report
3. To calculate the cost of antibacterial drug treatment 		 The secondary outcomes will be assessed after completion of the study 
 
Target Sample Size   Total Sample Size="700"
Sample Size from India="700" 
Final Enrollment numbers achieved (Total)= "700"
Final Enrollment numbers achieved (India)="700" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   25/05/2014 
Date of Study Completion (India) 01/07/2015 
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)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

Demographics:

A total of 700 participants were recruited across the five centers (140 per centers). The median age across centers was 48 (13, 92). There were 424 (60.57%) male and 276 (39.43%) female.

Indicators:

In public (KEM and Nair) and government-Tata  (autonomous) hospitals, the average number of drugs were significantly higher compared to private (Bombay and Subharti ) hospitals; however, average number of antibacterials in government hospital were significantly higher compared to public and private hospitals. The average number of antibacterials prescribed in KEM Hospital (2.93 ± 2.12) were significantly higher than the Nair Hospital (1.28 ±0.53); although both the hospitals are public hospitals. Percentage of antibacterials prescribed at public hospitals were not significantly higher than the government hospital and private hospitals (p=0.2009); however, the percentage of antibacterials prescribed at Nair hospital were significantly lower than the other centers (p<0.0001).  Percentage of patients received antibacterials were significantly different between public, government and private hospitals (p=0.0014) and between the individual centers (p=0.0003).  Private hospitals had lower percentage of antibacterial agents prescribed by generic name (P< 0.0001). There was no significant difference in intravenous use (p=0.2586) of antibacterials and the fixed dose combinations (p=0.91).  At government and private hospitals, none of the patient received antibacterial from hospital pharmacy.
Nair Hospital had significantly lower percentage of patients in whom antibacterial agent was changes over the course of MICU admission as well as had very low percentage of antibacterial treatment as per sensitivity pattern (p< 0.0001). Subharti Hospital had least percentage of patients who received antibacterial treatment as per sensitivity pattern and is statistically significant (< 0.0001). KEM Hospital had longer average length of antibacterial treatment and longer length of empirical use of antibacterials as well as longer length of MICU stay compared to all other centers. Bombay Hospital and Tata hospital had highest per patient cost of antibacterial treatment. Public hospital had significantly lower per patient cost of antibacterial treatment (<0.0001). Significantly higher mortality was observed in public and government hospitals compared to private hospitals (< 0.0001). Penicillins, glycopeptides, Beta-Lactams and Polymyxin-E were comparatively largely prescribed at KEM and Tata hospitals. Cephalosporin’s use was high at public hospitals. At Bombay hospital flouroquinolones was largely prescribed. Prescription of Vancomycin and Colistin was found to be higher at KEM and Tata hospital.

Pooled data:

Patients in MICU received as many as 10.90 (± 6.83) drugs, of which only 1.98 ± 1.36 (16.11 %) were the antibacterials. Over the study period, 92.42 % patients received antibacterials of which 41.00% antibacterials were prescribed by generic name. A total of 93.89 % antibacterials prescribed intravenously. Only 28% antibacterials were prescribed from hospital pharmacy. Change of antibacterial agent was required in 31.75 % patients and only 3.54 % were prescribed as FDCs. The average length of MICU stay was 6.33 (±7.31), average length of antibacterial treatment was 6.38 (±7.54) and average duration of empirical treatment was 5.94 (±5.35). Across the centers average antibacterial cost per patient was 7781.58 (± 4636.054). A total of 88 culture tests were positive amongst 212 patients, from which 71 (80.68%) patients received antibacterials as per sensitivity pattern.
A total of 293.41 DDDs/100 bed days’ antibacterials consumed over the study period.  Large amount of antibacterials consumed at KEM (91.93 DDDs/100 bed days), Tata (94.60 DDDs/100 bed days) and Bombay (75.87 DDDs/100 bed days) hospitals compared to Nair (16.90 DDDs/100 bed days) and Subharti (14.11 DDDs/100 bed days) hospitals. Penicillins (KEM-18.79 DDDs/100 bed days, Bombay-23.48 DDDs/100 bed days) and cephalosporins (KEM=23.67 DDDs/100 bed days, Bombay=22.28 DDDs/100 bed days) were largely consumed at KEM and Bombay, while the glycopeptides (Tata-8.73 DDDs/100 bed days and KEM-7.08 DDDs/100 bed days) and B-lactams (Tata-32.6 DDDs/100 bed days and KEM-14.14 DDDs/100 bed days)  were highly consumed at Tata  and KEM Hospital.  
 
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