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.
Study Type
OBSERVATIONAL
Enrollment
189
Non-Interventional Study
Fortis Hospital
Bhandup West, India
Apollo Hospital
Chennai, India
Gleneagles Global Hospitals
Chennai, India
Deenanath Mangeshkar Hospital and Research Centre
Erandwane,, PUNE, India
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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Day 7 after ceftazidime-avibactam initiation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Apollo Hospital
Hyderabad, India
Metro Hospital
Noida, India
Grant Medical Foundation Ruby Hall Clinic
Pune, India
Amri Hospital
WEST Bengal, India
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).
Time frame: 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.
Time frame: 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 Classified According to Source of Infection at Baseline for Which Ceftazidime-Avibactam Was Used
Source of infection included hospital-acquired infection, healthcare-associated infection, and community-acquired infection.
Time frame: Baseline (before initiation of initial antibiotic therapy)
Number of Participants According to Indication at Baseline for Which Ceftazidime-Avibactam Was Used
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.
Time frame: Baseline (before the initiation of initial antibiotic therapy)
Dose of Ceftazidime - Avibactam
In this outcome measure dose (median of daily dose) of ceftazidime-avibactam was reported till Day 14 or End of treatment whichever was earlier.
Time frame: Up to Day 14 or End of treatment after ceftazidime-avibactam initiation, whichever was earlier
Number of Participants According to Frequency of Administration
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.
Time frame: Up to Day 14 or End of treatment after ceftazidime-avibactam initiation, whichever was earlier
Duration of Administration of Ceftazidime - Avibactam
Time frame: Up to Day 14 or End of treatment after ceftazidime-avibactam initiation, whichever was earlier
Total Duration of Therapy of Ceftazidime-Avibactam
Time frame: 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
Time frame: Up to Day 14 or End of treatment after ceftazidime-avibactam initiation, whichever was earlier
Number of Participants With History of Antibiotic Exposure
Time frame: 90 days prior to current hospital admission
Number of Participants According to Identified Gram Negative Organisms
In this outcome measure, the gram-negative organisms identified at baseline was reported. One participant could have more than one gram-negative bacteria identified.
Time frame: Baseline (before the initiation of initial antibiotic therapy)
Number of Participants With Identified Pathogens Susceptible to Ceftazidime-Avibactam
Time frame: Baseline (before the initiation of initial antibiotic therapy)
Duration of Hospital Stay
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.
Time frame: Up to 30 days post treatment completion, death or discharge; whichever was first (Up to maximum of 49 days)
Duration of Stay in Intensive Care Unit (ICU)
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.
Time frame: Up to 30 days post treatment completion, death or discharge; whichever was first (Up to maximum of 49 days)
Number of Participants According to Healthcare Resource Utilization
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.
Time frame: 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
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.
Time frame: Up to 30 days post treatment completion with ceftazidime-avibactam, death or discharge; whichever was first (Up to maximum of 49 days)