Clinical trial NCT04628572: Retrospective Analysis of Real World Use of Ceftazidime-avibactam in the Management of Gram Negative Infections
Official title: Retrospective Analysis to Characterize the Real World Use Patterns, Efficacy and Safety of Ceftazidime-avibactam in the Management of Gram Negative Infections.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gram Negative Infections
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-11-13
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients with documented gram negative infection and treated with Ceftazidime-avibactam for atleast 48 hours.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Clinical Symptom Improvement at Day 3
timeFrame: Day 3 after ceftazidime-avibactam initiation
measure: Number of Participants With Treatment Success at Day 7
timeFrame: Day 7 after ceftazidime-avibactam initiation
measure: Number of Participants With Treatment Success at Day 14 or End of Treatment
timeFrame: Day 14 or End of Treatment after ceftazidime-avibactam initiation, whichever was earlier
measure: Number of Participants With Microbiological Success at Day 7
timeFrame: Day 7 after ceftazidime-avibactam initiation
measure: Number of Participants With Microbiological Success at Day 14 or End of Treatment
timeFrame: Day 14 or End of Treatment after ceftazidime-avibactam initiation, whichever was earlier
measure: Number of Participants With Serious Adverse Events and Non-Serious Adverse Events With Explicit Attribution to Ceftazidime-Avibactam
timeFrame: Up to 30 days post treatment completion with ceftazidime-avibactam, death or discharge; whichever was first (Up to maximum of 49 days)
Secondary outcomes:
measure: Number of Participants Classified According to Source of Infection at Baseline for Which Ceftazidime-Avibactam Was Used
timeFrame: Baseline (before initiation of initial antibiotic therapy)
measure: Number of Participants According to Indication at Baseline for Which Ceftazidime-Avibactam Was Used
timeFrame: Baseline (before the initiation of initial antibiotic therapy)
measure: Dose of Ceftazidime - Avibactam
timeFrame: Up to Day 14 or End of treatment after ceftazidime-avibactam initiation, whichever was earlier
measure: Number of Participants According to Frequency of Administration
timeFrame: Up to Day 14 or End of treatment after ceftazidime-avibactam initiation, whichever was earlier
measure: Duration of Administration of Ceftazidime - Avibactam
timeFrame: Up to Day 14 or End of treatment after ceftazidime-avibactam initiation, whichever was earlier
measure: Total Duration of Therapy of Ceftazidime-Avibactam
timeFrame: Up to Day 14 or End of treatment after ceftazidime-avibactam initiation, whichever was earlier
measure: Number of Participants Who Received Concomitant Antibiotics With Ceftazidime-Avibactam
timeFrame: Up to Day 14 or End of treatment after ceftazidime-avibactam initiation, whichever was earlier
measure: Number of Participants With History of Antibiotic Exposure
timeFrame: 90 days prior to current hospital admission
measure: Number of Participants According to Identified Gram Negative Organisms
timeFrame: Baseline (before the initiation of initial antibiotic therapy)
measure: Number of Participants With Identified Pathogens Susceptible to Ceftazidime-Avibactam
timeFrame: Baseline (before the initiation of initial antibiotic therapy)
measure: Duration of Hospital Stay
timeFrame: Up to 30 days post treatment completion, death or discharge; whichever was first (Up to maximum of 49 days)
measure: Duration of Stay in Intensive Care Unit (ICU)
timeFrame: Up to 30 days post treatment completion, death or discharge; whichever was first (Up to maximum of 49 days)
measure: Number of Participants According to Healthcare Resource Utilization
timeFrame: Up to 30 days post treatment completion with ceftazidime-avibactam death or discharge; whichever was first (Up to maximum of 49 days)
measure: Number of Participants With Recurrence of Infection
timeFrame: Up to 30 days post treatment completion with ceftazidime-avibactam, death or discharge; whichever was first (Up to maximum of 49 days)
Other outcomes:
Locations:
city: Bhandup West
country: India
facility: Fortis Hospital
city: Chennai
country: India
facility: Apollo Hospital
city: Chennai
country: India
facility: Gleneagles Global Hospitals
city: Erandwane,, PUNE
country: India
facility: Deenanath Mangeshkar Hospital and Research Centre
city: Hyderabad
country: India
facility: Apollo Hospital
city: Noida
country: India
facility: Metro Hospital
city: Pune
country: India
facility: Grant Medical Foundation Ruby Hall Clinic
city: WEST Bengal
country: India
facility: Amri Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: