Retrospective Analysis of Real World Use of Ceftazidime-avibactam in the Management of Gram Negative Infections

Sponsor

Pfizer (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04628572

Collaborator

(none)

500

Enrollment

Locations

17.9

Anticipated Duration (Months)

100

Patients Per Site

5.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main objective of this non-interventional (retrospective) study is to describe the general treatment patterns, effectiveness, and safety of ceftazidime-avibactam in real-world settings in India. Eligible patients would be adults who have been treated with ≥ 48 hours of ceftazidime-avibactam in routine practice from 01 June 2019 to 01 April 2020. Data of 500 patients will be collected through the abstraction of hospital medical records (electronic) if available or through the individual patient medical record in case electronic records are not available.

Condition or Disease	Intervention/Treatment	Phase
Gram Negative Infections	Drug: Ceftazidime-avibactam

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

Retrospective Analysis to Characterize the Real World Use Patterns, Efficacy and Safety of Ceftazidime-avibactam in the Management of Gram Negative Infections

Actual Study Start Date :

Feb 1, 2021

Anticipated Primary Completion Date :

Jul 31, 2022

Anticipated Study Completion Date :

Jul 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Cohort 1 Eligible adults who have been treated with ≥ 48 hours of ceftazidime-avibactam in routine practice	Drug: Ceftazidime-avibactam Non-Interventional Study

Arm

Intervention/Treatment

Cohort 1

Eligible adults who have been treated with ≥ 48 hours of ceftazidime-avibactam in routine practice

Drug: Ceftazidime-avibactam

Non-Interventional Study

Outcome Measures

Primary Outcome Measures

Percent treatment success of patients treated with ceftazidime-avibactam [At Day 7 from ceftazidime avibactam initiation]
Percent treatment success of patients treated with ceftazidime-avibactam [At day 14/ End of treatment from Ceftazidime-avibactam initiation, whichever is earlier]
Percent microbiological success among patients treated with ceftazidime-avibactam [At Day 7 from ceftazidime-avibactam initiation]
Percent microbiological success among patients treated with ceftazidime-avibactam [At day 14/ end of the treatment from Ceftazidime- avibactam initiation, whichever is earlier]
Number of patients with serious and non-serious AEs with explicit attribution to Ceftazidime avibactam [Upto 30 days post treatment completion with Ceftazidime- Avibactam, death or discharge; whatever is first]

Secondary Outcome Measures

Percentage of patients with different sources of infection for which ceftazidime-avibactam was used. [At baseline]
Percentage of patients given ceftazidime avibactam for different indications [At baseline]
Describe the dose of ceftazidime avibactam in mg [Till 14 days/ End of the treatment with Ceftazidime-avibactam , whichever is earlier]
Describe the frequency of dosing for ceftazidime- avibactam in hours [Till 14 days/ End of the treatment with ceftazidime- avibactam, whichever is earlier]
Describe the duration of treatment with Ceftazidime avibactam in days [Till 14 Days/ End of the treatment with Ceftazidime-Avibactam, whichever is earlier]
Percentage of patients who have been administered various combination antibiotic regimens along with ceftazidime avibactam [Till 14 days/ end of treatment with Ceftazidime-avibactam, whichever is earlier]
Describe any prior antimicrobial therapy administered in the 90 days prior to current admission [At baseline]
Describe the gram negative organisms identified and the susceptibility to ceftazidime -avibactam along with molecular typing [At baseline]
Describe the in-hospital length of stay (LOS) in days in patients with infections treated by ceftazidime-avibactam [Up to 30 days post treatment completion with Ceftazidime- Avibactam death or discharge; whatever is first]
Describe the length of stay in ICU in days in patients with infections treated by ceftazidime-avibactam [Up to 30 days post treatment completion with Ceftazidime- Avibactam death or discharge; whatever is first.]
Percentage of various healthcare resource utilization in patients with infections treated by ceftazidime-avibactam [Up to 30 days post treatment completion with Ceftazidime- Avibactam death or discharge; whatever is first.]
Determine the incidence of recurrent infections during the hospital stay, including re-infection and relapse [Up to 30 days post treatment completion with Ceftazidime- Avibactam, death or discharge; whatever is first.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

more than or equal to 18 years of age
Admitted to hospital with documented gram negative infection
Has received treatment for atleast 48 hours (complete) with Ceftazidime-Avibactam as a part of his routine clinical management

Exclusion Criteria:

The patient is enrolled in any clinical trial of an investigational product
Age <18 years
Received Ceftazidime avibactam for less than 48 hours.
Patient with documented Acinetobacter infection.
Patient was a part of named access program or any other interventional study

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Apollo Hospital	Chennai	India	600006
2	Gleneagles Global Hospitals	Chennai	India	600100
3	Metro Hospital	Noida	India	201301
4	Grant Medical Foundation Ruby Hall Clinic	Pune	India	411001
5	Amri Hospital	WEST Bengal	India	700098