| CTRI Number |
CTRI/2024/08/071992 [Registered on: 06/08/2024] Trial Registered Prospectively |
| Last Modified On: |
06/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treatment of carbapenem resistant acinetobacter baumanni pneumoniae |
|
Scientific Title of Study
|
Polymyxin B combined with sulbactam versus Polymyxin B combined with tigecycline in the treatment of carbapenem resistant acinetobacter baumanni pneumoniae |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anthur Ajay Nair |
| Designation |
Junior Consultant |
| Affiliation |
PSG Hospitals |
| Address |
Department of Critical Care Medicine
PSG Hospitals
Coimbatore
TAMIL NADU
641004
India |
| Phone |
|
| Fax |
|
| Email |
nairajay574@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sruthi Menon |
| Designation |
Clinical Pharmacist |
| Affiliation |
PSG Hospitals |
| Address |
Department of Critical Care Medicine
PSG Hospitals
Coimbatore
TAMIL NADU
641004
India |
| Phone |
9500899503 |
| Fax |
|
| Email |
sruthikwt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sruthi Menon |
| Designation |
Clinical Pharmacist |
| Affiliation |
PSG Hospitals |
| Address |
Department of Critical Care Medicine
PSG Hospitals
Coimbatore
TAMIL NADU
641004
India |
| Phone |
9500899503 |
| Fax |
|
| Email |
sruthikwt@gmail.com |
|
|
Source of Monetary or Material Support
|
| PSG Hospitals
Peelamedu
Coimbatore
Tamil Nadu
641004 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 Anthur Ajay Nair |
PSG Hospitals |
Department of Critical Care Medicine
Coimbatore
TAMIL NADU |
9741140246
nairajay574@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE PSG HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B998||Other infectious disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
POLYMIXIN-B plus SALBACTAM |
POLYMYXIN-B- 20.000U/kg-25,000U/kg loading dose given in 100ml NS over 30 minutes; followed by 12,500-15,000U/kg q12h maintenence dose given in 100ml NS over 2hours
SULBACTAM- 3g loading dose(given in 100ml NS over 30 minutes);3g Q8h(given in 100ml NS over 2h
Duration: 7-14 days depending on clinical improvement as per physician choice |
| Comparator Agent |
POLYMYXIN-B plus TIGECYCLINE |
POLYMYXIN-B- 20.000U/kg-25,000U/kg loading dose given in 100ml NS over 30 minutes; followed by 12,500-15,000U/kg q12h maintenence dose given in 100ml NS over 2hours
SULBACTAM- POLYMYXIN-B- 20.000U/kg-25,000U/kg loading dose given in 100ml NS over 30 minutes; followed by 12,500-15,000U/kg q12h maintenence dose given in 100ml NS over 2hours
TIGECYCLINE- 200mg loading(given in 100ml NS over 30minutes); 100mg q12h(given in 100ml NS over 2h)
Duration: 7-14 days depending on clinical improvement as per physician choice |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosis of HAP or VAP |
|
| ExclusionCriteria |
| Details |
Isolation of more than one organism in respiratory specimens
CRAB resistant to tigecycline and colistin
Pregnant patients
Patients not willing to participate in the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ICU MORTALITY |
At baseline, week 7, week 10 and week 14. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Length of hospital stay
Length of ICU stay
Number of ventilator days
|
DAY 7
DAY 10
DAY 14 |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
22/08/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
There is no clear “standard of care†antibiotic regimen for CRAB infections. The current preferred approach for treating CRAB pneumonia in our intensive care unit is a combination of polymixin B with tigecycline or salbactam, depending on the physician choice. There is no data comparing the effectiveness of combination of Poymyxin B with sulbactam and Polymyxin B with Tigecyclline for CRAB pneumonia. Hence the need to conduct the study. |