Retrospective Analysis of Real World Use of Ceftazidime-avibactam in the Management of Gram Negative Infections
- Conditions
- Gram Negative Infections
- Interventions
- Drug: Ceftazidime-avibactam
- Registration Number
- NCT04628572
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 189
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort 1 Ceftazidime-avibactam Eligible adults who have been treated with ≥ 48 hours of ceftazidime-avibactam in routine practice
- Primary Outcome Measures
Name Time Method Number of Participants With Clinical Symptom Improvement at Day 3 Day 3 after ceftazidime-avibactam initiation The clinical symptom improvement was assessed as per the clinical judgement of the physician and reported as symptom improved and symptom worsened.
Number of Participants With Microbiological Success at Day 14 or End of Treatment Day 14 or End of Treatment after ceftazidime-avibactam initiation, whichever was earlier 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).
Number of Participants With Serious Adverse Events and Non-Serious Adverse Events With Explicit Attribution to Ceftazidime-Avibactam Up to 30 days post treatment completion with ceftazidime-avibactam, death or discharge; whichever was first (Up to maximum of 49 days) 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.
Number of Participants With Treatment Success at Day 7 Day 7 after ceftazidime-avibactam initiation 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).
Number of Participants With Treatment Success at Day 14 or End of Treatment Day 14 or End of Treatment after ceftazidime-avibactam initiation, whichever was earlier 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).
Number of Participants With Microbiological Success at Day 7 Day 7 after ceftazidime-avibactam initiation 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).
- Secondary Outcome Measures
Name Time Method Number of Participants Classified According to Source of Infection at Baseline for Which Ceftazidime-Avibactam Was Used Baseline (before initiation of initial antibiotic therapy) Source of infection included hospital-acquired infection, healthcare-associated infection, and community-acquired infection.
Number of Participants With History of Antibiotic Exposure 90 days prior to current hospital admission Number of Participants According to Identified Gram Negative Organisms Baseline (before the initiation of initial antibiotic therapy) In this outcome measure, the gram-negative organisms identified at baseline was reported. One participant could have more than one gram-negative bacteria identified.
Number of Participants With Identified Pathogens Susceptible to Ceftazidime-Avibactam Baseline (before the 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) The indications for use of ceftazidime-avibactam at baseline including urinary tract infection, intra-abdominal infection and nosocomial pneumonia and any other indication were reported.
Duration of Administration of Ceftazidime - Avibactam Up to Day 14 or End of treatment after ceftazidime-avibactam initiation, whichever was earlier Total Duration of Therapy of Ceftazidime-Avibactam Up to Day 14 or End of treatment after ceftazidime-avibactam initiation, whichever was earlier Number of Participants Who Received Concomitant Antibiotics With Ceftazidime-Avibactam Up to Day 14 or End of treatment after ceftazidime-avibactam initiation, whichever was earlier Dose of Ceftazidime - Avibactam Up to Day 14 or End of treatment after ceftazidime-avibactam initiation, whichever was earlier In this outcome measure dose (median of daily dose) of ceftazidime-avibactam was reported till Day 14 or End of treatment 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 Number of participants according to frequency of administration (twice daily \[BID\], once daily \[OD\] and thrice daily \[TID\]) of ceftazidime-avibactam is reported in this outcome measure.
Duration of Hospital Stay Up to 30 days post treatment completion, death or discharge; whichever was first (Up to maximum of 49 days) Duration of hospital stay was calculated based on 1) total number of consecutive days the participant was treated in the hospital from admission to discharge during their initial hospitalization; 2) the total number of days of hospitalization between diagnosis of infection and discharge; 3) the total number of days the participant was treated in the hospital after ceftazidime-avibactam initiation up to hospital discharge, including the first day of treatment.
Duration of Stay in Intensive Care Unit (ICU) Up to 30 days post treatment completion, death or discharge; whichever was first (Up to maximum of 49 days) Intensive care unit length of stay was calculated based on 1) the total number of consecutive or non-consecutive days the participant was treated in the ICU during their initial hospitalization; and 2) the total number of days the participant was treated in the ICU after ceftazidime-avibactam initiation, including the first day of treatment.
Number of Participants With Recurrence of Infection Up to 30 days post treatment completion with ceftazidime-avibactam, death or discharge; whichever was first (Up to maximum of 49 days) Number of participants with recurrence of infection during hospital stay, including re-infection and relapse up to 30 days post treatment completion with ceftazidime-avibactam, death or discharge; whichever occurred first was summarized in this outcome measure.
Number of Participants According to Healthcare Resource Utilization Up to 30 days post treatment completion with ceftazidime-avibactam death or discharge; whichever was first (Up to maximum of 49 days) In this outcome measure number of participants were reported as per their healthcare resource utilization data, abstracted from the participant medical records. Healthcare resources included: mechanical ventilation, computed tomography (CT)/magnetic resonance imaging (MRI), tracheostomy, hemodialysis, surgical intervention, percutaneous procedures and other procedures.
Trial Locations
- Locations (7)
Fortis Hospital
🇮🇳Bhandup West, India
Metro Hospital
🇮🇳Noida, India
Grant Medical Foundation Ruby Hall Clinic
🇮🇳Pune, India
Deenanath Mangeshkar Hospital and Research Centre
🇮🇳Erandwane,, PUNE, India
Apollo Hospital
🇮🇳Hyderabad, India
Gleneagles Global Hospitals
🇮🇳Chennai, India
Amri Hospital
🇮🇳WEST Bengal, India