Effectiveness of newer antibiotic combination named as ceftazidime avibactam for the treatment of blood infection due to Multi Drug Resistant gram negative bacteria.

Active, not recruiting

• Conditions: Certain infectious and parasitic diseases,

• Registration Number: CTRI/2023/06/054356
• Lead Sponsor: Medanta Institute of Education and Research

Brief Summary

Bacteremia is associated with increased mortality and morbidity. Early initiation of appropriate antibiotics is associated with improved outcomes. Currently there are few options for treating bacteremia due to MDR gram negative infections, one of which is Ceftazidime -avibactam. Real world evidence studies globally have shown its effectiveness in the management of MDR gram negative infections. The epidemiology of MDR gram negative infections in India differs from the epidemiology worldwide and hence demonstrating the effectiveness of ceftazidime avibactam in the Indian scenario is essential.

The present study will look at the trends in usage of ceftazidime-avibactam (including day of initiation) in bacteremia along with clinical and microbiological outcomes. This study is Single centre, retrospective, non-interventional.  The sample size of the study is 125. Adult patients, Bacteremic patients with Documented MDR GNB infection, Received ceftazidime avibactam for atleast 48 hours as per clinician’s discretion will be included in the study. The patients with documented Acinetobacter infection, Pure MBL isolated will not be included in the study. Primary outcome of the study is 1) Clinical outcomes at Day 3 and day 14/EOT from the initiation of ceftazidime avibactam  2) Mortality at day 14  and Secondary outcome is 1) All cause mortality at day 30  2) Day of ceftazidime avibactam initiation, average dose and duration 3) No of patients-initiated with  Ceftazidime avibactam within  48-72 hour after diagnosis  and outcomes correlation  4) Source of bacteremia 5) Causative organism, median time from admission to isolation of organism from culture 6) Molecular typing outcomes if available, susceptibility for ceftazidime-avibactam 7) Concomitant medications (baseline & combination) 8) Length of hospital stay. The enrollment period for collection of data retrospectively is from Jan 2020 to July 2022. The study duration is of one year.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-30
• Last Update Posted: 2024-10-02

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

Adult patients, Bacteremic patients with Documented MDR GNB infection, Received ceftazidimeavibactam for atleast 48 hours as per clinician’s discretion.

Exclusion Criteria

Documented Acinetobacter infection, Pure MBL isolated (if available).

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Clinical outcomes at Day 3 & day 14/EOT from the initiation of ceftazidime avibactam 2) Mortality at day 14	Day 3 & Day 14/ End of Treatment

Secondary Outcome Measures

Name	Time	Method
1) All cause mortality at day 30 2) Day of ceftazidime avibactam initiation, average dose and duration 3) No of patients-initiated with Ceftazidime avibactam within 48-72 hour after diagnosis and outcomes correlation 4) Source of bacteremia 5) Causative organism, median time from admission to isolation of organism from culture 6) Molecular typing outcomes if available, susceptibility for ceftazidime-avibactam 7) Concomitant medications (baseline & combination) 8) Length of hospital stay	Day 30

Trial Locations

Locations (1)

Medanta, The Medicity; 🇮🇳 Gurgaon, HARYANA, India

Medanta, The Medicity

🇮🇳Gurgaon, HARYANA, India

Dr Deepak Govil

Principal investigator

9818056688

drdeepak_govil@yahoo.co.in