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CTRI Number  CTRI/2023/10/058761 [Registered on: 17/10/2023] Trial Registered Prospectively
Last Modified On: 16/10/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Study to evaluate clinical effects of Polymyxins and Ceftazidime-Avibactum in critical patients and evaluate which group has better outcomes (CoP CAcRE) 
Scientific Title of Study   Clinical outcomes of Ceftazidime-Avibactam Versus Polymyxins in Critically ill Patients With Carbapenem Resistant Enterobacteraceae Infections in Tertiary Care Hospital 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Neha Bhardwaj 
Designation  Senior resident 
Affiliation  Army Hospital, Research and Referral 
Address  Intesive care unit, Department of Anaesthesia and critical care, second floor OPD building Army Hospital Research and referral, Delhi
Intesive care unit, Department of Anaesthesia and critical care, second floor OPD building Army Hospital Research and referral, Delhi
South
DELHI
110010
India 
Phone  09540840669  
Fax    
Email  gaurinehabhardwaj@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Gp capt Dr Manish Dhawan 
Designation  Senior advisor critical care medicine 
Affiliation  Army Hospital, Research and Referral 
Address  Intesive care unit, Department of Anaesthesia and critical care, second floor OPD building Army Hospital Research and referral, Delhi,110010
Intesive care unit, Department of Anaesthesia and critical care, second floor OPD building Army Hospital Research and referral, Delhi,110010
South
DELHI
110010
India 
Phone  9535360243  
Fax    
Email  dhawanmanish2000@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Neha Bhardwaj 
Designation  Senior resident 
Affiliation  Army Hospital, Research and Referral 
Address  Intesive care unit, Department of Anaesthesia and critical care, second floor OPD building Army Hospital Research and referral, Delhi,110010
Intesive care unit, Department of Anaesthesia and critical care, second floor OPD building Army Hospital Research and referral, Delhi,110010
South
DELHI
110010
India 
Phone  09540840669  
Fax    
Email  gaurinehabhardwaj@gmail.com  
 
Source of Monetary or Material Support  
army hospital research and referral, Delhi ,110010 
 
Primary Sponsor  
Name  Research institution  
Address  army hospital research and referral, delhi,110010 
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 
Dr Neha Bhardwaj  army hospital Research and Referral, Delhi,110010  Intesive care unit, Department of Anaesthesia and critical care, second floor OPD building Army Hospital Research and referral, Delhi,110010
South
DELHI 		 09540840669

gaurinehabhardwaj@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-H Institutional AHRR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R652||Severe sepsis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1.Critically ill patients admitted in ICU with features of Sepsis
2.Microbiological culture confirmed CRE infection (Pulmonary and Blood stream)
3.Patients who have received CAZ/AVI or Polymyxins for at least 72 hours

 
 
ExclusionCriteria 
Details  1.Polymicrobial cultures
2.Patients who have already received CAZ/AVI or Polymyxins before ICU admission
3.Patients with CKD
4.Patients with chemotherapy or immunosuppressant therapy in last three months
• Post organ transplant patients
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine and compare Clinical success rate between two groups of patients

 		 14 days

 
 
Secondary Outcome  
Outcome  TimePoints 
1.To determine & compare length of ICU stay between two groups of patients
2. To determine and compare bacteriological clearance within 72 hours of antibiotic initiation
3. Evaluation of side effects between two groups
 		 72 hours
14 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   28/10/2023 
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   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Carbapenem-resistant Enterobacteriaceae (CREs) have been regarded as one of fatal medical threats to the public health based on World Health Organization priority list of antibiotic resistant bacteria.The pharmacotherapy of carbapenem-resistant Enterobacteriaceae (CRE) infections is challenging and has typically included multiple antibiotics. Ceftazidime/avibactam is a new β-lactam/β-lactamase inhibitor combination recently approved for the treatment of CRE and has proved efficacious.Recent surge in CRE also has led re-introduction of Polymyxins as one of limited treatment options. Clinical studies about comparing clinical efficacy of CAZ/AVI and polymyxins-based therapeutic regimens in CRE infections in critically ill patients are still few. Hence, we designed a study to compare clinical outcomes of CAZ/AVI with Polymyxins in critically ill patients with CRE infections when used as monotherapy or in combination with other antibiotics depending upon the microbiological data. This prospective observational comparative study would be carried out in Critical care department of Army Hospital Research and Referral, New Delhi over a period of one and half years Total of 60 patients with age ≥18 years, with features of Sepsis  and microbiological culture confirmed CRE infection (Pulmonary and Blood stream)  and who have received CAZ/AVI or Polymyxins for at least 72 hours would be included in the study. Various demographic, clinical, lab parameters would be recorded daily  up to 72 hours of treatment cessation or duration of therapy.Primary Objective is to determine and compare Clinical success rate between two groups of patients and secondary objectives include  to determine and compare length of ICU stay between two groups of patients ,to determine and compare bacteriological clearance within 72 hours of antibiotic initiation and evaluation of side effects between two groups.Statistical tests will be applied as follows1.Quantitative variables will be compared using Unpaired t-test/Mann-Whitney Test (when the data sets were not normally distributed) between the two groups. 2.Qualitative variables will be compared using Chi-Square test /Fisher’s exact test. A p value of <0.05 will be considered statistically significant. The data will be entered in MS EXCEL spreadsheet and analysis will be done using Statistical Package for Social Sciences (SPSS) version 21.0. 
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