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CTRI Number  CTRI/2021/12/039035 [Registered on: 29/12/2021] Trial Registered Prospectively
Last Modified On: 28/12/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Observational 
Study Design  Other 
Public Title of Study   ANTIMICROBIAL RESISTANT DRUGS(SUPER BUGS) AND RESPONSE TO DIFFERENT ANTIBIOTICS 
Scientific Title of Study   CARBAPENEM RESISTANCE AMONG ENTEROBACTERIACEAE(CRE), PSEUDOMONAS AERUGINOSA(CRPsA) AND ACINETOBACTER BAUMANNII(CRAB) AND RESPONSES TO DIFFERENT ANTIBIOTICS 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR VIJAYA KUMAR MUTHAYALA 
Designation  DM STUDENT 
Affiliation  SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION ND RESEARCH 
Address  DEPARTMENT OF CRITICAL CARE MEDICINE, SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH, PORUR, CHENNAI, TAMIL NADU.

Chennai
TAMIL NADU
600116
India 
Phone  9642599067  
Fax    
Email  m5520002@sriramachandra.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  DR RENUKA MK 
Designation  PROFESSOR AND GUIDE 
Affiliation  SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION ND RESEARCH 
Address  DEPARTMENT OF CRITICAL CARE MEDICINE, SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH, PORUR, CHENNAI, TAMIL NADU.

Chennai
TAMIL NADU
600116
India 
Phone  8056126336  
Fax    
Email  renuramanujam@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR RENUKA MK 
Designation  PROFESSOR AND GUIDE 
Affiliation  SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION ND RESEARCH 
Address  DEPARTMENT OF CRITICAL CARE MEDICINE, SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH, PORUR, CHENNAI, TAMIL NADU.

Chennai
TAMIL NADU
600116
India 
Phone  8056126336  
Fax    
Email  renuramanujam@gmail.com  
 
Source of Monetary or Material Support  
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH, NO 1 RAMACHANDRA NAGAR,PORUR, CHENNAI 
 
Primary Sponsor  
Name  DR VIJAYA KUMAR MUTHAYALA 
Address  SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH, NO 1 RAMACHANDRA NAGAR,PORUR, CHENNAI,TAMILNADU.600116 
Type of Sponsor  Other [SELF] 
 
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 VIJAYA KUMAR MUTHAYALA  SRI RAMCHANDRA INSTITUTE OF HIGHER EDUCATION  DEPARTMENT OF CRITICAL CARE MEDICINE, NO 1RAMACHANDRA NAGAR, PORUR
Chennai
TAMIL NADU 
9642599067

m5520002@sriramachandra.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRI RAMACHANDRA INSTITUTIONAL RESEARCH ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B968||Other specified bacterial agents as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1)Age more than 18 years
2)Admitted with or later developed sepsis due carbapenem resistant organisms
3)Patients who receive 1 or more antibiotics showing invitro activity against carbapenem resistant organisms for at least 48 hours .
 
 
ExclusionCriteria 
Details  1)Age less than 18 years.
2)Polymicrobial infections comprising carbapenem-susceptible Gram-negative bacteria
3)Unable to follow up for 30 days
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
clinical response
1)Improvement in sofa score (if baseline sofa score greater than 3 decrease in score by 30%, if sofa score is less than or equal to 3 decrease by at least 1 point) and
2)Liberation from mechanical ventilation and
3)Stable hemodynamic without vasopressor support 
with in 14 days of antibiotic initiation 
 
Secondary Outcome  
Outcome  TimePoints 
Mortality  30 days 
Microbiological failure - Is defines as repeat isolation of bacteria phenotypically identical to the index isolate   on or after 7 days of antibiotic initiation 
Microbiological relapse - Repeat isolation of bacteria phenotypically identical to the index isolate after negative culture to treatment   with in 30 days 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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)   01/01/2022 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Carbapenem resistant gram-negative bacteria defined as gram negative organisms tested resistant to at least one of the carbapenem antibiotics i.e., meropenem, imipenem, doripenem or producing a carbapenemase. Infection with CR organisms Increases length of hospital stay and increases the mortality as well as higher direct and indirect healthcare costs. Carbapenemase producing bacteria is responsible for increased mortality with inappropriate antibiotic therapy. In a Prospective multi center observational study 30-day Mortality benefit ceftazidime avibactam (n=38) vs  colistin (n=99) observed as 9% vs 32%, Colistin group had more renal failure 5% vs 24% compared to ceftazidime Avibactam group. They  concluded that Ceftazidime avibactam may be reasonable alternative to colistin for KPC producing CRE infections. However, they included only KPC producing organisms, NDM and OXA 48 producing organisms are common in Indian population. Another prospective multicenter study done by Marco Falcone et al found ceftazidime avibactam and aztreonam(n=52) vs other active antibiotics combinations(n=50) had lower mortality 19.2 vs 44% for treating MBL producing Enterobacteriaceae and drug induced AKI was 1.9 in CFZ AVI AZT group vs 20% among colistin based regimens. Mortality in this group of patients may not be solely attributed to infection because of the underlying severity of primary disease. Clinical response in terms of the decreased need for vasopressors, liberation from mechanical ventilation ,renal replacement free days after initiation of antibiotic which are initiated due to sepsis could be better predictors in these circumstances.

 The present study is designed to observe clinical response as well as mortality benefit and microbiological response in patients treated with or going to treat with ceftazidime avibactam with or without aztreonam compared to other active antibiotics in carbapenem resistance gram negative bacterial infections. This study will be pure observational study, choice of antibiotic depends on treating consultant.

 
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