| 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
|
|
|
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
|
|
|
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. |