| CTRI Number |
CTRI/2024/05/066803 [Registered on: 06/05/2024] Trial Registered Prospectively |
| Last Modified On: |
26/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Urosepsis and Intra abdominal Sepsis |
|
Scientific Title of Study
|
Effectiveness
of Ceftazidime Avibactum for treatment of Urosepsis and Intra abdominal Sepsis due to multidrug resistant gram negative bacteria :A retrospective observational study |
| 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 Prachee Sathe |
| Designation |
Interventionalist Director ICU |
| Affiliation |
Ruby Hall Clinic Grant Medical Foundation, 40 Sasoon Road Pune 411001 |
| Address |
Ruby Hall Clinic, Grant Medical Foundation,FIRST FLOOR ICU 1, 40 Sasoon Road Pune 411001
Pune
MAHARASHTRA
411001
India |
| Phone |
09960686867 |
| Fax |
02066455628 |
| Email |
prachee.sathe@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prachee Sathe |
| Designation |
Interventionalist Director ICU |
| Affiliation |
Ruby Hall Clinic Grant Medical Foundation, 40 Sasoon Road Pune 411001 |
| Address |
Ruby Hall Clinic, Grant Medical Foundation, FIRST FLOOR ICU 1 ,
40 Sasoon Road Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
09960686867 |
| Fax |
02066455628 |
| Email |
prachee.sathe@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prachee Sathe |
| Designation |
Interventionalist Director ICU |
| Affiliation |
Ruby Hall Clinic Grant Medical Foundation, |
| Address |
Ruby Hall Clinic, Grant Medical Foundation, FIST FLOOR 40 Sasoon Road Pune 411001
40 Sasoon Road Pune 411001
Pune
MAHARASHTRA
411001
India |
| Phone |
09960686867 |
| Fax |
02066455628 |
| Email |
prachee.sathe@gmail.com |
|
|
Source of Monetary or Material Support
|
| HOSPITAL INPATIENT MEDICAL RECORDS FROM 01 APRIL 2020 TO 31 MARCH 2023 FROM RUBY HALL CLINIC GRANT MEDICAL FOUNDATION 40 SASSOON ROAD PUNE 411001(PATIENTS WHO WERE ADMITTED FOR UROSEPSIS AND INTRAABDOMINAL SEPSIS AND RECIEVED ZAVICEFTA TO TREAT THE SAME |
|
|
Primary Sponsor
|
| Name |
Pfizer PHARMACEUTICALS |
| Address |
1802/1902, The Capital, ‘G’ Block, BKC, Bandra (East), Mumbai – 400051, India |
| Type of Sponsor |
Contract research organization |
|
|
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 PRACHEE SATHE |
RUBY HALL CLINIC GRANT MEDICAL FOUNDATION ICU FIRST FLOOR MAIN BUILDING |
40 sassoon road pune 411001
Pune
MAHARASHTRA |
9960686867
02066455628
prachee.sathe@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Poona Medical Research Foundation IEC Biomedical Health Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: N37||Urethral disorders in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL As it is an Observational Study |
NIL As it is an Observational Study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
WERE CONSECUTIVELY ADMITTED TO THE HOSPITAL BETWEEN 01 APRIL 2020 AND 31 MARCH 2023
HAD SUSPECTED OR DOCUMENTED MDR GRAM NEGATIVE INTRA ABDOMINAL SEPSIS OR UROSEPSIS
SEPSIS WAS DIAGNOSED ACCORDING TO THE THIRD INTERNATIONAL CONSENSUS DEFINITION FOR SEPSIS AND SEPTIC SHOCK
RECIEVED CEFTAZIDIME AVIBACTUM FOR ATLEAST 48 HOURS AS PER CLINICIAN DISCRETION |
|
| ExclusionCriteria |
| Details |
DOCUMENTED ACINETOBACTER INFECTION
RECIEVED CEFTADIZIME AVIBACTUM LESS THAN 48 HOURS |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
IN PATIENT MORTALITY
CLINICAL OUTCOMES MEASURED ON DAY 3 AND DAY 14 /END OF TREATMENT FROM THE INITIATIONOF CEFTAZIDIME AVIBACTUM TREATMENT. |
IN PATIENT MORTALITY
CLINICAL OUTCOMES MEASURED ON DAY 3 AND DAY 14 /END OF TREATMENT FROM THE INITIATIONOF CEFTAZIDIME AVIBACTUM TREATMENT. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
14 DAYS ALL CAUSE MORTALITY
MICROBIOLOGICAL OUTCOMES
30 DAYS ALL CAUSE MORTALITY
RECURRENCE OF INFECTION
SAFETY
LENGTH OF HOSPITAL STAY
LENGTH OF ICU STAY
DY OF CEFTAZIDIME AVIBACTUM INITIATION AVERAGE DOSE AND DURATION
CLINICAL OUTCOMES IN PATIENTS INITIATED WITH CEFTAZIDIME AVIBACTUMWITHIN 48 TO 72 HOURS FROM DIAGNOSIS OF INFECTION
DISTRIBUTION OF PATHOGENS AND SUSCEPTIBILITY TO CEFTAZIDIME AVIBACTUM IF AVAILABLE
GENOTYPING RESULTS IF AVAILABLE
CONCOMITANT ANTIBIOTIC MEDICATIONS WITH CEFTAZIDIME AVIBACTUM |
14 TO 30 DAYS |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
13/05/2024 |
| 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="0"
Months="8"
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
|
INTRA ABDOMINAL INFECTION ARE SECOND COMMON CAUSE OF SEPSIS AFTER PULMONARY CAUSES WITH MORTALITY RATE AROUND 30% AND UROSEPSIS ACCOUNTS ABOUT 25%OF SEPSIS CAUSES WITH MORTALITY RATE 20% TO 40% RECENT DATA FROM INDIA (2021) SHOWS MICROBIAL SUSCEPTIBILITY TO DIFFERENT ANTIBIOTICS HAS BEEN REDUCING OVER THE YEARS THUS MAKING MULTIDRUG RESISTANT BACTERIAL INFECTIONS A PRESSING CHALLENGE. CEFTADIZIME AVIBACTUM IS APPROVED IN INDIAFOR THE TREATMENT OF BACTEREMIA SECONDARY TO COMPLICATED URINARY TRACT INFECTION AND INTRA ABDOMINAL INFECTIONS .HOWEVER THERE IS LACK OF REAL WORLD EVIDENCE DEMONSTRATING EFFE3CTIVENESS OF CEFTADIZIME AVIBACTUM IN UROSEPSISAND INTRA ABDOMINAL SEPSIS IN INDIAN SETTING. THIS STUDY AIMS TO UNDERSTAND THE EFFECTIVENESS OF CEFTADIZIME AVIBACTUM IN INDIAN SETTING AND WOULD ALSO HELPS DOCTORS UNDERSTAND EPIDEMOLOGY OG MDR GRAM NEGATIVE BACTERIA IN UROSEPSIS AND INTRA ABDOMINAL SEPSIS
|