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

NCT04628572 | Completed Results FDA Drug

• 1 other identifier: X9001260
• Study Type: observational
• Target: 189
• Locations: 1 country
• Sites: 8

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.

Conditions

Gram Negative Infections

Outcome Measures

Primary Outcomes (6)

• Number of Participants With Clinical Symptom Improvement at Day 3

  The clinical symptom improvement was assessed as per the clinical judgement of the physician and reported as symptom improved and symptom worsened.

  Day 3 after ceftazidime-avibactam initiation

• Number of Participants With Treatment Success at Day 7

  The treatment success was defined as resolution of all signs and symptoms of the infection based on the clinician's judgment and the treatment protocol/algorithm followed at the respective centers. The treatment success in terms of clinical outcome was classified as clinical success (resolution of all signs and symptoms of the infection), clinical failure (persistence of signs and symptoms from baseline) and indeterminate (there is not enough information to conclude whether the antibiotic regimen containing ceftazidime-avibactam was a clinical failure or a success).

  Day 7 after ceftazidime-avibactam initiation

• Number of Participants With Treatment Success at Day 14 or End of Treatment

  The treatment success was defined as resolution of all signs and symptoms of the infection based on the clinician's judgment and the treatment protocol/algorithm followed at the respective centers. The treatment success in terms of clinical outcome was classified as clinical success (resolution of all signs and symptoms of the infection), clinical failure (persistence of signs and symptoms from baseline) and indeterminate (there is not enough information to conclude whether the antibiotic regimen containing ceftazidime-avibactam was a clinical failure or a success).

  Day 14 or End of Treatment after ceftazidime-avibactam initiation, whichever was earlier

• Number of Participants With Microbiological Success at Day 7

  Microbiological success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication) and repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication).

  Day 7 after ceftazidime-avibactam initiation

• Number of Participants With Microbiological Success at Day 14 or End of Treatment

  Microbiological success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication) and repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication).

  Day 14 or End of Treatment after ceftazidime-avibactam initiation, whichever was earlier

• Number of Participants With Serious Adverse Events and Non-Serious Adverse Events With Explicit Attribution to Ceftazidime-Avibactam

  An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. All AEs that did not meet the criteria for "serious" were considered as non-serious. Adverse events with explicit attribution to any Pfizer drug that appeared in the reviewed information (defined per the participant population and study period specified in the protocol) were reported. Explicit attribution was not inferred by temporal relationship between drug administration and an AE, but was based on a causality assessed by a healthcare provider linking drug administration and AE.

  Up to 30 days post treatment completion with ceftazidime-avibactam, death or discharge; whichever was first (Up to maximum of 49 days)

Secondary Outcomes (14)

• Number of Participants Classified According to Source of Infection at Baseline for Which Ceftazidime-Avibactam Was Used

  Baseline (before initiation of initial antibiotic therapy)

• Number of Participants According to Indication at Baseline for Which Ceftazidime-Avibactam Was Used

  Baseline (before the initiation of initial antibiotic therapy)

• Dose of Ceftazidime - Avibactam

  Up to Day 14 or End of treatment after ceftazidime-avibactam initiation, whichever was earlier

• Number of Participants According to Frequency of Administration

  Up to Day 14 or End of treatment after ceftazidime-avibactam initiation, whichever was earlier

• Duration of Administration of Ceftazidime - Avibactam

  Up to Day 14 or End of treatment after ceftazidime-avibactam initiation, whichever was earlier

Study Arms (1)

Cohort 1

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

Drug: Ceftazidime-avibactam

Interventions

Ceftazidime-avibactam DRUG

Non-Interventional Study

Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized patients with documented gram negative infection and treated with Ceftazidime-avibactam for atleast 48 hours.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (8)

Fortis Hospital

Bhandup West, 400078, India

Location

Apollo Hospital

Chennai, 600006, India

Location

Gleneagles Global Hospitals

Chennai, 600100, India

Location

Deenanath Mangeshkar Hospital and Research Centre

Erandwane,, PUNE, 411004, India

Location

Apollo Hospital

Hyderabad, HYDERABAD, India

Location

Metro Hospital

Noida, 201301, India

Location

Grant Medical Foundation Ruby Hall Clinic

Pune, 411001, India

Location

Amri Hospital

WEST Bengal, 700098, India

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

avibactam, ceftazidime drug combination

Results Point of Contact

• Title: Pfizer Clinical Trials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: November 13, 2020
• Study Start: January 29, 2021
• Primary Completion: March 11, 2022
• Study Completion: March 11, 2022
• Last Updated: August 14, 2024
• Results First Posted: August 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (8)