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

Gram Negative Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04628572
• Other study ID #: X9001260
• Status: Completed
• Start date: January 29, 2021
• Est. completion date: March 11, 2022

Study information

• Verified date: January 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: March 11, 2022
• Est. primary completion date: March 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. more than or equal to 18 years of age

2. Admitted to hospital with documented gram negative infection

3. Has received treatment for atleast 48 hours (complete) with Ceftazidime-Avibactam as a part of his routine clinical management

Exclusion Criteria:

1. The patient is enrolled in any clinical trial of an investigational product

2. Age <18 years

3. Received Ceftazidime avibactam for less than 48 hours.

4. Patient with documented Acinetobacter infection.

5. Patient was a part of named access program or any other interventional study

Related Conditions & MeSH terms

• Communicable Diseases
• Gram Negative Infections
• Infections

Intervention

Drug:
• Ceftazidime-avibactam
Non-Interventional Study

Locations

Country	Name	City	State
India	Fortis Hospital	Bhandup West
India	Apollo Hospital	Chennai
India	Gleneagles Global Hospitals	Chennai
India	Deenanath Mangeshkar Hospital and Research Centre	Erandwane,, PUNE
India	Apollo Hospital	Hyderabad
India	Metro Hospital	Noida
India	Grant Medical Foundation Ruby Hall Clinic	Pune
India	Amri Hospital	WEST Bengal

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent treatment success of patients treated with ceftazidime-avibactam		At Day 7 from ceftazidime avibactam initiation
Primary	Percent treatment success of patients treated with ceftazidime-avibactam		At day 14/ End of treatment from Ceftazidime-avibactam initiation, whichever is earlier
Primary	Percent microbiological success among patients treated with ceftazidime-avibactam		At Day 7 from ceftazidime-avibactam initiation
Primary	Percent microbiological success among patients treated with ceftazidime-avibactam		At day 14/ end of the treatment from Ceftazidime- avibactam initiation, whichever is earlier
Primary	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	Percentage of patients with different sources of infection for which ceftazidime-avibactam was used.		At baseline
Secondary	Percentage of patients given ceftazidime avibactam for different indications		At baseline
Secondary	Describe the dose of ceftazidime avibactam in mg		Till 14 days/ End of the treatment with Ceftazidime-avibactam , whichever is earlier
Secondary	Describe the frequency of dosing for ceftazidime- avibactam in hours		Till 14 days/ End of the treatment with ceftazidime- avibactam, whichever is earlier
Secondary	Describe the duration of treatment with Ceftazidime avibactam in days		Till 14 Days/ End of the treatment with Ceftazidime-Avibactam, whichever is earlier
Secondary	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
Secondary	Describe any prior antimicrobial therapy administered in the 90 days prior to current admission		At baseline
Secondary	Describe the gram negative organisms identified and the susceptibility to ceftazidime -avibactam along with molecular typing		At baseline
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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.

External Links

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