Gram Negative Infections
Conditions
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.
Interventions
Non-Interventional Study
Sponsors
Pfizer
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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). |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 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. |
| 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 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. |
| 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. |
| 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. |
| 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. |
| 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 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 | — |
Countries
India
Participant flow
Recruitment details
Participants who were hospitalized with Gram negative infections and received ceftazidime-avibactam for at least 48 hours in routine clinical practice were included in this retrospective study. Data was collected from electronic health records or participant's medical records. Data was collected for the period from 01-Jun-2019 to 01-Apr-2020 (approximately 10 months).
Participants by arm
| Arm | Count |
|---|---|
| Ceftazidime-Avibactam Eligible participants who were hospitalized with Gram negative infections and received ceftazidime-avibactam for at least 48 hours in routine clinical practice were included. | 189 |
| Total | 189 |
Baseline characteristics
| Characteristic | Ceftazidime-Avibactam | — |
|---|---|---|
| Age, Continuous | 55.6 Years STANDARD_DEVIATION 17.8 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 66 Participants | — |
| Sex: Female, Male Male | 123 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 189 |
| other Total, other adverse events | 0 / 189 |
| serious Total, serious adverse events | 0 / 189 |
Outcome results
Primary
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
Population: Analysis population included all participants who received ceftazidime-avibactam for at least 48 hours. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ceftazidime-Avibactam | Number of Participants With Clinical Symptom Improvement at Day 3 | Symptom Worsened | 21 Participants |
| Ceftazidime-Avibactam | Number of Participants With Clinical Symptom Improvement at Day 3 | Symptom Improved | 82 Participants |
Primary
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
Population: Analysis population included all participants who received ceftazidime-avibactam for at least 48 hours. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ceftazidime-Avibactam | Number of Participants With Microbiological Success at Day 14 or End of Treatment | Eradication | 24 Participants |
| Ceftazidime-Avibactam | Number of Participants With Microbiological Success at Day 14 or End of Treatment | Presumed Eradication | 17 Participants |
Primary
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
Population: Analysis population included all participants who received ceftazidime-avibactam for at least 48 hours. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ceftazidime-Avibactam | Number of Participants With Microbiological Success at Day 7 | Eradication | 31 Participants |
| Ceftazidime-Avibactam | Number of Participants With Microbiological Success at Day 7 | Presumed Eradication | 7 Participants |
Primary
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)
Population: Analysis population included all participants who received ceftazidime-avibactam for at least 48 hours.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ceftazidime-Avibactam | Number of Participants With Serious Adverse Events and Non-Serious Adverse Events With Explicit Attribution to Ceftazidime-Avibactam | Serious adverse events | 0 Participants |
| Ceftazidime-Avibactam | Number of Participants With Serious Adverse Events and Non-Serious Adverse Events With Explicit Attribution to Ceftazidime-Avibactam | Non-serious adverse events | 0 Participants |
Primary
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
Population: Analysis population included all participants who received ceftazidime-avibactam for at least 48 hours. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ceftazidime-Avibactam | Number of Participants With Treatment Success at Day 14 or End of Treatment | Clinical Success | 45 Participants |
| Ceftazidime-Avibactam | Number of Participants With Treatment Success at Day 14 or End of Treatment | Clinical Failure | 13 Participants |
| Ceftazidime-Avibactam | Number of Participants With Treatment Success at Day 14 or End of Treatment | Clinical Indeterminate | 1 Participants |
Primary
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
Population: Analysis population included all participants who received ceftazidime-avibactam for at least 48 hours. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ceftazidime-Avibactam | Number of Participants With Treatment Success at Day 7 | Clinical Success | 66 Participants |
| Ceftazidime-Avibactam | Number of Participants With Treatment Success at Day 7 | Clinical Failure | 12 Participants |
| Ceftazidime-Avibactam | Number of Participants With Treatment Success at Day 7 | Clinical Indeterminate | 5 Participants |
Secondary
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
Population: Analysis population included all participants who received ceftazidime-avibactam for at least 48 hours.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ceftazidime-Avibactam | Dose of Ceftazidime - Avibactam | 2500 Milligrams |
Secondary
Duration of Administration of Ceftazidime - Avibactam
Time frame: Up to Day 14 or End of treatment after ceftazidime-avibactam initiation, whichever was earlier
Population: Analysis population included all participants who received ceftazidime-avibactam for at least 48 hours.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ceftazidime-Avibactam | Duration of Administration of Ceftazidime - Avibactam | 2.1 Hours | Standard Deviation 0.8 |
Secondary
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)
Population: Analysis population included all participants who received ceftazidime-avibactam for at least 48 hours.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ceftazidime-Avibactam | Duration of Hospital Stay | 23.1 Days | Standard Deviation 15.1 |
Secondary
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)
Population: Analysis population included all participants who received ceftazidime-avibactam for at least 48 hours. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ceftazidime-Avibactam | Duration of Stay in Intensive Care Unit (ICU) | 15.7 Days | Standard Deviation 14.3 |
Secondary
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
Population: Analysis population included all participants who received ceftazidime-avibactam for at least 48 hours.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ceftazidime-Avibactam | Number of Participants According to Frequency of Administration | BID | 71 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Frequency of Administration | OD | 22 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Frequency of Administration | TID | 96 Participants |
Secondary
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)
Population: Analysis population included all participants who received ceftazidime-avibactam for at least 48 hours. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ceftazidime-Avibactam | Number of Participants According to Healthcare Resource Utilization | Mechanical ventilation | 82 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Healthcare Resource Utilization | CT/MRI imaging | 59 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Healthcare Resource Utilization | Tracheostomy | 36 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Healthcare Resource Utilization | Surgical intervention | 16 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Healthcare Resource Utilization | Percutaneous procedures | 5 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Healthcare Resource Utilization | Other procedure (Other healthcare resources utilized) | 22 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Healthcare Resource Utilization | Hemodialysis | 25 Participants |
Secondary
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)
Population: Analysis population included all participants who received ceftazidime-avibactam for at least 48 hours. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ceftazidime-Avibactam | Number of Participants According to Identified Gram Negative Organisms | Klebsiella pneumoniae | 57 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Identified Gram Negative Organisms | Escherichia Coli | 15 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Identified Gram Negative Organisms | Pseudomonas aeruginosa | 11 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Identified Gram Negative Organisms | Klebsiella species | 4 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Identified Gram Negative Organisms | Enterobacter cloacae | 1 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Identified Gram Negative Organisms | Proteus mirabilis | 1 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Identified Gram Negative Organisms | Pseudomonas species | 1 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Identified Gram Negative Organisms | Other | 1 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Identified Gram Negative Organisms | Enterobacter species | 1 Participants |
Secondary
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)
Population: Analysis population included all participants who received ceftazidime-avibactam for at least 48 hours.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ceftazidime-Avibactam | Number of Participants According to Indication at Baseline for Which Ceftazidime-Avibactam Was Used | Urinary Tract Infection | 55 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Indication at Baseline for Which Ceftazidime-Avibactam Was Used | Intra-abdominal Infection | 30 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Indication at Baseline for Which Ceftazidime-Avibactam Was Used | Nosocomial Infection | 55 Participants |
| Ceftazidime-Avibactam | Number of Participants According to Indication at Baseline for Which Ceftazidime-Avibactam Was Used | Others | 49 Participants |
Secondary
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)
Population: Analysis population included all participants who received ceftazidime-avibactam for at least 48 hours.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ceftazidime-Avibactam | Number of Participants Classified According to Source of Infection at Baseline for Which Ceftazidime-Avibactam Was Used | Hospital-Acquired Infection | 72 Participants |
| Ceftazidime-Avibactam | Number of Participants Classified According to Source of Infection at Baseline for Which Ceftazidime-Avibactam Was Used | Healthcare Associated Infection | 65 Participants |
| Ceftazidime-Avibactam | Number of Participants Classified According to Source of Infection at Baseline for Which Ceftazidime-Avibactam Was Used | Community-Acquired Infection | 52 Participants |
Secondary
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
Population: Analysis population included all participants who received ceftazidime-avibactam for at least 48 hours.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ceftazidime-Avibactam | Number of Participants Who Received Concomitant Antibiotics With Ceftazidime-Avibactam | 156 Participants |
Secondary
Number of Participants With History of Antibiotic Exposure
Time frame: 90 days prior to current hospital admission
Population: Analysis population included all participants who received ceftazidime-avibactam for at least 48 hours.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ceftazidime-Avibactam | Number of Participants With History of Antibiotic Exposure | 126 Participants |
Secondary
Number of Participants With Identified Pathogens Susceptible to Ceftazidime-Avibactam
Time frame: Baseline (before the initiation of initial antibiotic therapy)
Population: Analysis population included all participants who received ceftazidime-avibactam for at least 48 hours. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ceftazidime-Avibactam | Number of Participants With Identified Pathogens Susceptible to Ceftazidime-Avibactam | 34 Participants |
Secondary
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)
Population: Analysis population included all participants who received ceftazidime-avibactam for at least 48 hours.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ceftazidime-Avibactam | Number of Participants With Recurrence of Infection | 8 Participants |
Secondary
Total Duration of Therapy of Ceftazidime-Avibactam
Time frame: Up to Day 14 or End of treatment after ceftazidime-avibactam initiation, whichever was earlier
Population: Analysis population included all participants who received ceftazidime-avibactam for at least 48 hours.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ceftazidime-Avibactam | Total Duration of Therapy of Ceftazidime-Avibactam | 6.92 Days | Standard Deviation 4.1 |