Urosepsis and Intra abdominal Sepsis

Not yet recruiting

Conditions: Urethral disorders in diseases classified elsewhere,

Registration Number: CTRI/2024/05/066803

Lead Sponsor: Pfizer PHARMACEUTICALS

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

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

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.

Exclusion Criteria

DOCUMENTED ACINETOBACTER INFECTION RECIEVED CEFTADIZIME AVIBACTUM LESS THAN 48 HOURS.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
IN PATIENT MORTALITY	IN PATIENT MORTALITY \| CLINICAL OUTCOMES MEASURED ON DAY 3 AND DAY 14 /END OF TREATMENT FROM THE INITIATIONOF CEFTAZIDIME AVIBACTUM TREATMENT.

Secondary Outcome Measures

Name	Time	Method
14 DAYS ALL CAUSE MORTALITY	MICROBIOLOGICAL OUTCOMES

Trial Locations

Locations (1): RUBY HALL CLINIC GRANT MEDICAL FOUNDATION ICU FIRST FLOOR MAIN BUILDING
🇮🇳
Pune, MAHARASHTRA, India
RUBY HALL CLINIC GRANT MEDICAL FOUNDATION ICU FIRST FLOOR MAIN BUILDING
🇮🇳Pune, MAHARASHTRA, India
DR PRACHEE SATHE
Principal investigator
9960686867
prachee.sathe@gmail.com