| CTRI Number |
CTRI/2022/09/045736 [Registered on: 21/09/2022] Trial Registered Prospectively |
| Last Modified On: |
16/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparison of newer and higher dose antibiotics combination therapy with old and standard antibiotics combination therapy in critically ill patients who are carbapenem resistant enterobacteriaceae (CRE) |
|
Scientific Title of Study
|
To compare the efficacy of two combination therapies against carbapenem resistant enterobacteriaceae
Meropenem plus colistin versus high dose tigecycline plus colistin in critically ill patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
JAHANARA |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College,Aligarh Muslim University,Aligarh |
| Address |
Department of Anaesthesiology and critical care Jawaharlal Nehru Medical College, Aligarh Muslim University
Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
08755671505 |
| Fax |
|
| Email |
jahanara627@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ABU NADEEM |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Nehru Medical College,Aligarh Muslim University,Aligarh |
| Address |
Department of Anaesthesiology and critical care Jawaharlal Nehru Medical College, Aligarh Muslim University
Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9837757772 |
| Fax |
|
| Email |
drabunadeem@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
JAHANARA |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College,Aligarh Muslim University,Aligarh |
| Address |
Department of Anaesthesiology and critical care Jawaharlal Nehru Medical College, Aligarh Muslim University
Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
08755671505 |
| Fax |
|
| Email |
jahanara627@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and Critical and Care JNMCH, AMU, Aligarh |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology and Critical and Care Jawaharlal Nehru Medical College AMU Aligarh |
| Address |
Department of Anaesthesiology and Critical and Care JNMCH, AMU, Aligarh |
| Type of Sponsor |
Government medical college |
|
|
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 |
| JAHANARA |
Jawaharlal Nehru Medical college, AMU |
Department of anaesthesia and critical Care,JNMCH,AMU Aligarh
Aligarh
UTTAR PRADESH |
08755671505
Jahanara627@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R799||Abnormal finding of blood chemistry, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
High dose Tigecycline and colistin |
GROUP B : High dose Tigecycline (200mg loading dose followed by 100mg twice daily maintenance dose) plus colistin(9MIU loading dose followed by 2-3MIU thrice daily maintenance dose) for 2 days |
| Comparator Agent |
Meropenem and colistin |
GROUP A : Meropenem (1gm thrice daily) plus
colistin (9MIU loading dose followed by 2-3MIU thrice daily maintenance dose) for 2 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient having sepsis and SOFA score of 2 or more than 2 at the time of admission in icu/ccw.
2. There should be an isolates of carbapenem resistant enterobacteriaceae (CRE) positive either from Blood, tracheal aspirates, urine or abdominal pus culture.
3. Patient on any empirical antibiotics except current combination therapy .
|
|
| ExclusionCriteria |
| Details |
1. Patient who is not having sepsis and having SOFA score of less than 2. Non Carbapenem resistant enterobacteriaceae (CRE) patients.
3. Patient who expire within 48 hours of starting the combination
therapy.
4. Patient having sensitivity to the drug use .
5. Covid -19 positive patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To see the changes in sequential organ failure assessment (SOFA) score at zero hour and after 48 hours of starting combination therapies meropenem plus colistin and high dose tigecycline plus colistin in carbapenem resistant enterobacteriaceae positive cases. |
2 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To see the microbiological eradication of carbapenem resistant enterobacteriaceae on 5th day and to report any mortality within 5 days of starting the antibiotics combination therapies . |
5 days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
26/09/2022 |
| 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
|
Carbepenem resistant enterobacteriaceae (CRE) , a major resistance concern during last decade and become the important focus of infection . New and effective therapeutic strategies developed for the treatment of CRE positive patients like to increasing the doses of anti CRE agents and to combine these anti CRE infections .
AIM OF THE STUDY : PRIMARY OBJECTIVE : see the SOFA score changes at zero hour and 48hours of starting the treatments
SECONDARY OBJECTIVE: See the microbiological eradication and mortality within 5th day starting the antibiotics.
METHODS AAND MATERIALS: Study will be conducted on 80 patients admitted in the icu/ccw of JNMCH,AMU,ALIGARH Group A will receive meropenem(1gm 3 times daily ) and colistin (9MIU loadind followed by 2-3 MIU) while group B receive high dose tigecycline (200mg loadind followed by 100mg 2 times a day) and colistin
RESULT: To see changes in SOFA SCORE AFTER 48 HOURS OF STARTING THE ANTIBIOTICS COMBINATION AND SEE THE ERADICATION AND MORTALITY WITHIN 5TH DAY . |