Trial Outcomes & Findings for Real-World Observational Study Of Zavicefta to Characterize Use Patterns (NCT NCT03923426)

NCT ID: NCT03923426

Last Updated: 2024-06-21

Results Overview

The number of participants classified according to reason for discontinuing for prior antibiotic therapy were reported in this outcome measure. One participant could have more than 1 reason of discontinuation for prior antibiotic therapy.

Recruitment status

COMPLETED

Target enrollment

572 participants

Primary outcome timeframe

Up to 90 days prior to index date (from the data evaluated in approximately 40 months of this study)

Results posted on

2024-06-21

Participant Flow

Participants who were hospitalized with gram-negative infection and received at least one dose of ceftazidime-avibactam in routine clinical practice since 01-Jan-2018 were included in this chart review study. Participants were recruited across Europe and Latin America and were followed from ceftazidime-avibactam initiation until 60 days post hospital discharge, mortality, withdrawal from the study, or loss-to-follow-up, whichever occurred first.

Data was abstracted from medical records and evaluated over approximately 40 months of this study.

Participant milestones

Participant milestones
Measure
Ceftazidime-avibactam
Eligible participants who were hospitalized with gram negative infections and received at least one dose of ceftazidime-avibactam in routine clinical practice since 01-Jan-2018 were included in this chart review study.
Overall Study
STARTED
572
Overall Study
Full Analysis Set
569
Overall Study
COMPLETED
417
Overall Study
NOT COMPLETED
155

Reasons for withdrawal

Reasons for withdrawal
Measure
Ceftazidime-avibactam
Eligible participants who were hospitalized with gram negative infections and received at least one dose of ceftazidime-avibactam in routine clinical practice since 01-Jan-2018 were included in this chart review study.
Overall Study
Other
19
Overall Study
Lost to Follow-up
16
Overall Study
Death
107
Overall Study
Incomplete response to question
13

Baseline Characteristics

Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Ceftazidime-avibactam
n=569 Participants
Eligible participants who were hospitalized with gram negative infections and received at least one dose of ceftazidime-avibactam in routine clinical practice since 01-Jan-2018 were included in this chart review study.
Age, Continuous
FAS72+
58.3 Years
STANDARD_DEVIATION 18.37 • n=516 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Age, Continuous
FAS72-
59.7 Years
STANDARD_DEVIATION 17.99 • n=53 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Sex: Female, Male
FAS72+ · Female
164 Participants
n=516 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Sex: Female, Male
FAS72+ · Male
352 Participants
n=516 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Sex: Female, Male
FAS72- · Female
20 Participants
n=53 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Sex: Female, Male
FAS72- · Male
33 Participants
n=53 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Participants According to Their Employment Status
Full Time
78 Participants
n=516 Participants • Data is presented for FAS72+ analysis set.
Number of Participants According to Their Employment Status
Part Time
5 Participants
n=516 Participants • Data is presented for FAS72+ analysis set.
Number of Participants According to Their Employment Status
Unemployed
67 Participants
n=516 Participants • Data is presented for FAS72+ analysis set.
Number of Participants According to Their Employment Status
Retired
159 Participants
n=516 Participants • Data is presented for FAS72+ analysis set.
Number of Participants According to Their Employment Status
Not Available
207 Participants
n=516 Participants • Data is presented for FAS72+ analysis set.
Height: FAS72+ Analysis set
169.9 Centimeter (cm)
STANDARD_DEVIATION 9.35 • n=358 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the baseline characteristic.
Weight: FAS72+ Analysis set
76.0 Kilogram (kg)
STANDARD_DEVIATION 19.15 • n=368 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the baseline characteristic.
Number of Participants With Prior Hospitalizations Within 90 days Prior to Current Hospitalization
253 Participants
n=511 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the baseline characteristic.
Number of Participants With Antibiotic Exposure Within 90 Days Prior to Index Hospitalization
260 Participants
n=511 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the baseline characteristic.
Number of Participants With any Healthcare Procedure Within 30 Days Prior to Index Date
311 Participants
n=512 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the baseline characteristic.
Number of Participants According to Antibiotic Class Used Prior to Ceftazidime-Avibactam Initiation
Aminoglycosides
49 Participants
n=259 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the baseline characteristic.
Number of Participants According to Antibiotic Class Used Prior to Ceftazidime-Avibactam Initiation
Carbapenems
118 Participants
n=259 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the baseline characteristic.
Number of Participants According to Antibiotic Class Used Prior to Ceftazidime-Avibactam Initiation
Cephalosporins
73 Participants
n=259 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the baseline characteristic.
Number of Participants According to Antibiotic Class Used Prior to Ceftazidime-Avibactam Initiation
Fluoroquinolones
65 Participants
n=259 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the baseline characteristic.
Number of Participants According to Antibiotic Class Used Prior to Ceftazidime-Avibactam Initiation
Glycopeptides
81 Participants
n=259 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the baseline characteristic.
Number of Participants According to Antibiotic Class Used Prior to Ceftazidime-Avibactam Initiation
Glycylcycline
17 Participants
n=259 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the baseline characteristic.
Number of Participants According to Antibiotic Class Used Prior to Ceftazidime-Avibactam Initiation
Lipopeptides
17 Participants
n=259 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the baseline characteristic.
Number of Participants According to Antibiotic Class Used Prior to Ceftazidime-Avibactam Initiation
Macrolides
24 Participants
n=259 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the baseline characteristic.
Number of Participants According to Antibiotic Class Used Prior to Ceftazidime-Avibactam Initiation
Monobactam
5 Participants
n=259 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the baseline characteristic.
Number of Participants According to Antibiotic Class Used Prior to Ceftazidime-Avibactam Initiation
Nitroimidazole
26 Participants
n=259 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the baseline characteristic.
Number of Participants According to Antibiotic Class Used Prior to Ceftazidime-Avibactam Initiation
Other agents
65 Participants
n=259 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the baseline characteristic.
Number of Participants According to Antibiotic Class Used Prior to Ceftazidime-Avibactam Initiation
Oxazolidinones
27 Participants
n=259 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the baseline characteristic.
Number of Participants According to Antibiotic Class Used Prior to Ceftazidime-Avibactam Initiation
Penicillins
18 Participants
n=259 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the baseline characteristic.
Number of Participants According to Antibiotic Class Used Prior to Ceftazidime-Avibactam Initiation
Penicillins and beta-lactamase inhibitors
110 Participants
n=259 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the baseline characteristic.
Number of Participants According to Antibiotic Class Used Prior to Ceftazidime-Avibactam Initiation
Tetracycline
9 Participants
n=259 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the baseline characteristic.
Number of Participants According to Antibiotic Class Used Prior to Ceftazidime-Avibactam Initiation
Uncoded
48 Participants
n=259 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the baseline characteristic.
Number of Participants According to Country Travelled Within the Past 3 Months
Egypt
1 Participants
n=8 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for this baseline characteristic who travelled to other countries.
Number of Participants According to Country Travelled Within the Past 3 Months
Germany
1 Participants
n=8 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for this baseline characteristic who travelled to other countries.
Number of Participants According to Country Travelled Within the Past 3 Months
Italy
1 Participants
n=8 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for this baseline characteristic who travelled to other countries.
Number of Participants According to Country Travelled Within the Past 3 Months
Netherlands
1 Participants
n=8 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for this baseline characteristic who travelled to other countries.
Number of Participants According to Country Travelled Within the Past 3 Months
Pakistan
1 Participants
n=8 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for this baseline characteristic who travelled to other countries.
Number of Participants According to Country Travelled Within the Past 3 Months
Spain
2 Participants
n=8 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for this baseline characteristic who travelled to other countries.
Number of Participants According to Country Travelled Within the Past 3 Months
Turkey
1 Participants
n=8 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for this baseline characteristic who travelled to other countries.
Number of Participants With Reported Pregnancy
3 Participants
n=516 Participants • Data is presented for FAS72+ analysis set.
Number of Weeks of Gestation Since Last Menstrual Period
29.7 Weeks
STANDARD_DEVIATION 8.39 • n=3 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Participants With Alcohol use
41 Participants
n=516 Participants • Data is presented for FAS72+ analysis set.
Number of Alcoholic Drinks per Week: FAS72+ Analysis set
15.4 Drinks per week
STANDARD_DEVIATION 17.36 • n=31 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the baseline characteristic.
Number of Participants According to Tobacco use
Current Smoker
38 Participants
n=516 Participants • Data is presented for FAS72+ analysis set.
Number of Participants According to Tobacco use
Previous Smoker
88 Participants
n=516 Participants • Data is presented for FAS72+ analysis set.
Number of Participants According to Tobacco use
Never Smoked
165 Participants
n=516 Participants • Data is presented for FAS72+ analysis set.
Number of Participants According to Tobacco use
Unknown
225 Participants
n=516 Participants • Data is presented for FAS72+ analysis set.
Number of Cigarettes per day
For current smokers
20.4 Cigarettes per day
STANDARD_DEVIATION 8.76 • n=32 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Cigarettes per day
For previous smokers
19.6 Cigarettes per day
STANDARD_DEVIATION 13.27 • n=58 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Participants According to Source of Infection
Hospital-acquired infections (HAI)
354 Participants
n=516 Participants • Data is presented for FAS72+ analysis set.
Number of Participants According to Source of Infection
Healthcare-associated infections (HCAI)
116 Participants
n=516 Participants • Data is presented for FAS72+ analysis set.
Number of Participants According to Source of Infection
Community-acquired infection (CAI)
46 Participants
n=516 Participants • Data is presented for FAS72+ analysis set.
Number of Participants According to Other Indication for Ceftazidime-Avibactam
Surgical site infection (SSI)
15 Participants
n=209 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Participants According to Other Indication for Ceftazidime-Avibactam
Central line associated blood stream infection (CLABSI)
15 Participants
n=209 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Participants According to Other Indication for Ceftazidime-Avibactam
Bloodstream infection (BSI)/ Sepsis
97 Participants
n=209 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Participants According to Other Indication for Ceftazidime-Avibactam
Meningitis
0 Participants
n=209 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Participants According to Other Indication for Ceftazidime-Avibactam
Endocarditis
0 Participants
n=209 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Participants According to Other Indication for Ceftazidime-Avibactam
Osteomyelitis
7 Participants
n=209 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Participants According to Other Indication for Ceftazidime-Avibactam
Febrile neutropenia
24 Participants
n=209 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Participants According to Other Indication for Ceftazidime-Avibactam
Other
51 Participants
n=209 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Participants According to Initial Site of Infection
Bladder
2 Participants
n=163 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Participants According to Initial Site of Infection
Kidney
2 Participants
n=163 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Participants According to Initial Site of Infection
Large Intestine
5 Participants
n=163 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Participants According to Initial Site of Infection
Lungs
29 Participants
n=163 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Participants According to Initial Site of Infection
Liver
2 Participants
n=163 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Participants According to Initial Site of Infection
Gall Bladder
2 Participants
n=163 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Participants According to Initial Site of Infection
Pancreas
1 Participants
n=163 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Participants According to Initial Site of Infection
Peritoneum
4 Participants
n=163 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Participants According to Initial Site of Infection
Small Intestine
2 Participants
n=163 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Participants According to Initial Site of Infection
Urethra
11 Participants
n=163 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Participants According to Initial Site of Infection
Other
103 Participants
n=163 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Participants With Microbiological Cultures Performed for Current Infection Before Therapy
239 Participants
n=239 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the baseline characteristic.
Number of Pathogens Identified Before Ceftazidime-Avibactam Therapy
Gram-negative: Escherichia coli
21 Pathogens
n=239 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Pathogens Identified Before Ceftazidime-Avibactam Therapy
Gram-negative: Klebsiella pneumoniae
140 Pathogens
n=239 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Pathogens Identified Before Ceftazidime-Avibactam Therapy
Gram-negative: Klebsiella species (spp)
25 Pathogens
n=239 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Pathogens Identified Before Ceftazidime-Avibactam Therapy
Gram-negative: Proteus mirabilis
6 Pathogens
n=239 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Pathogens Identified Before Ceftazidime-Avibactam Therapy
Gram-negative: Proteus spp
1 Pathogens
n=239 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Pathogens Identified Before Ceftazidime-Avibactam Therapy
Gram-negative: Acinetobacter baumannii
16 Pathogens
n=239 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Pathogens Identified Before Ceftazidime-Avibactam Therapy
Gram-negative: Acinetobacter spp
1 Pathogens
n=239 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Pathogens Identified Before Ceftazidime-Avibactam Therapy
Gram-negative: Enterobacter cloacae
17 Pathogens
n=239 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Pathogens Identified Before Ceftazidime-Avibactam Therapy
Gram-negative: Enterobacter spp
5 Pathogens
n=239 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Pathogens Identified Before Ceftazidime-Avibactam Therapy
Gram-negative: Citrobacter spp
1 Pathogens
n=239 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Pathogens Identified Before Ceftazidime-Avibactam Therapy
Gram-negative: Serratia spp
3 Pathogens
n=239 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Pathogens Identified Before Ceftazidime-Avibactam Therapy
Gram-negative: Morganella morganii
2 Pathogens
n=239 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Pathogens Identified Before Ceftazidime-Avibactam Therapy
Gram-negative: Pseudomonas aeruginosa
30 Pathogens
n=239 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Pathogens Identified Before Ceftazidime-Avibactam Therapy
Gram-negative: Pseudomonas spp
3 Pathogens
n=239 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Pathogens Identified Before Ceftazidime-Avibactam Therapy
Gram-negative: Haemophilus spp
1 Pathogens
n=239 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Pathogens Identified Before Ceftazidime-Avibactam Therapy
Gram-negative: Other
9 Pathogens
n=239 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Pathogens Identified Before Ceftazidime-Avibactam Therapy
Gram-positive: Staphylococcus aureus
7 Pathogens
n=239 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Pathogens Identified Before Ceftazidime-Avibactam Therapy
Gram-positive: Staphylococcus spp
5 Pathogens
n=239 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Pathogens Identified Before Ceftazidime-Avibactam Therapy
Gram-positive: Enterococcus spp
23 Pathogens
n=239 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Pathogens Identified Before Ceftazidime-Avibactam Therapy
Gram-positive: Streptococcus spp
5 Pathogens
n=239 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Pathogens Identified Before Ceftazidime-Avibactam Therapy
Gram-positive: Other
10 Pathogens
n=239 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Pathogens Identified Before Ceftazidime-Avibactam Therapy
Anaerobes: Bacteroides spp
1 Pathogens
n=239 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Pathogens Identified Before Ceftazidime-Avibactam Therapy
Other Bacterial Agent
3 Pathogens
n=239 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Acute Physiology and Chronic Health Evaluation (APACHE) II Score
19.5 Scores on a scale
STANDARD_DEVIATION 7.93 • n=46 Participants • Data is presented for FAS72+ analysis set. Here, 'Number Analyzed' signifies number of participants evaluable for the baseline characteristic.
Number of Participants According to Indication for Ceftazidime-Avibactam
FAS72+ · Complicated Urinary Tract Infection (cUTI)
103 Participants
n=516 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Participants According to Indication for Ceftazidime-Avibactam
FAS72+ · Complicated Intra-Abdominal Infection (cIAI)
90 Participants
n=516 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Participants According to Indication for Ceftazidime-Avibactam
FAS72+ · Hospital-Acquired Pneumonia/Ventilator-Associated Pneumonia (HAP/VAP)
114 Participants
n=516 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Participants According to Indication for Ceftazidime-Avibactam
FAS72+ · Other
209 Participants
n=516 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Participants According to Indication for Ceftazidime-Avibactam
FAS72- · Complicated Urinary Tract Infection (cUTI)
7 Participants
n=53 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Participants According to Indication for Ceftazidime-Avibactam
FAS72- · Complicated Intra-Abdominal Infection (cIAI)
12 Participants
n=53 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Participants According to Indication for Ceftazidime-Avibactam
FAS72- · Hospital-Acquired Pneumonia/Ventilator-Associated Pneumonia (HAP/VAP)
10 Participants
n=53 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Participants According to Indication for Ceftazidime-Avibactam
FAS72- · Other
24 Participants
n=53 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of Participants With Comorbidities
Any comorbidities
479 Participants
n=516 Participants • Data is presented for FAS72+ analysis set.
Number of Participants With Comorbidities
No comorbidities
37 Participants
n=516 Participants • Data is presented for FAS72+ analysis set.

PRIMARY outcome

Timeframe: From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)

Population: FAS72+ population included all participants with at least 72 hours of exposure to ceftazidime-avibactam.

Number of participants who received at least one dose of ceftazidime-avibactam according to type of use as monotherapy or combination therapy was reported in this outcome measure. Index date was start date of ceftazidime-avibactam.

Outcome measures

Outcome measures
Measure
Ceftazidime-avibactam
n=516 Participants
Eligible participants who were hospitalized with gram negative infections and received at least one dose of ceftazidime-avibactam in routine clinical practice since 01-Jan-2018 were included in this chart review study.
Number of Participants Who Received at Least One Dose of Ceftazidime-Avibactam Classified According to Type of Usage as Monotherapy or Combination Therapy: FAS 72+ Population
Combination therapy
358 Participants
Number of Participants Who Received at Least One Dose of Ceftazidime-Avibactam Classified According to Type of Usage as Monotherapy or Combination Therapy: FAS 72+ Population
Monotherapy
158 Participants

PRIMARY outcome

Timeframe: From start of index treatment to end of index treatment (maximum 3 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)

Population: FAS72- population included all participants with \< 72 hours exposure to ceftazidime-avibactam. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Number of participants who received at least one dose of ceftazidime-avibactam according to type of use as monotherapy or combination therapy was reported in this outcome measure.

Outcome measures

Outcome measures
Measure
Ceftazidime-avibactam
n=10 Participants
Eligible participants who were hospitalized with gram negative infections and received at least one dose of ceftazidime-avibactam in routine clinical practice since 01-Jan-2018 were included in this chart review study.
Number of Participants Who Received at Least One Dose of Ceftazidime-Avibactam Classified According to Type of Usage as Monotherapy or Combination Therapy: FAS72- Population
Monotherapy
3 Participants
Number of Participants Who Received at Least One Dose of Ceftazidime-Avibactam Classified According to Type of Usage as Monotherapy or Combination Therapy: FAS72- Population
Combination therapy
7 Participants

PRIMARY outcome

Timeframe: From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)

Population: FAS72+ population included all participants with at least 72 hours of exposure to ceftazidime-avibactam.

The total cumulative dose and daily dose of ceftazidime-avibactam was reported in this outcome measure. Total cumulative dose was defined as the sum of all doses received.

Outcome measures

Outcome measures
Measure
Ceftazidime-avibactam
n=516 Participants
Eligible participants who were hospitalized with gram negative infections and received at least one dose of ceftazidime-avibactam in routine clinical practice since 01-Jan-2018 were included in this chart review study.
Total and Daily Dose of Ceftazidime-Avibactam: FAS72+ Population
Total dose
62.2 Milligram (mg)
Standard Deviation 55.82
Total and Daily Dose of Ceftazidime-Avibactam: FAS72+ Population
Daily dose
5.2 Milligram (mg)
Standard Deviation 1.52

PRIMARY outcome

Timeframe: From start of index treatment to end of index treatment (maximum 3 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)

Population: FAS72- population included all participants with \< 72 hours exposure to ceftazidime-avibactam.

The total cumulative dose and daily dose of ceftazidime-avibactam was reported in this outcome measure. Total cumulative dose was defined as the sum of all doses received.

Outcome measures

Outcome measures
Measure
Ceftazidime-avibactam
n=53 Participants
Eligible participants who were hospitalized with gram negative infections and received at least one dose of ceftazidime-avibactam in routine clinical practice since 01-Jan-2018 were included in this chart review study.
Total and Daily Dose of Ceftazidime-Avibactam: FAS72- Population
Total dose
6.3 Milligrams
Standard Deviation 3.65
Total and Daily Dose of Ceftazidime-Avibactam: FAS72- Population
Daily dose
4.8 Milligrams
Standard Deviation 1.96

PRIMARY outcome

Timeframe: From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)

Population: FAS72+ population included all participants with at least 72 hours of exposure to ceftazidime-avibactam.

Number of participants classified according to frequency of dose (once daily \[OD\], every other day \[QOD\], post-dialysis, each 48 hours \[h\], three times daily \[TID\], twice daily \[BD\], four times daily \[QID\], once loading dose \[an initial higher dose of a drug that may be given at the beginning of a course of treatment before dropping down to a lower maintenance dose\], every three days, once, etc.,) for ceftazidime-avibactam were reported in this outcome measure.

Outcome measures

Outcome measures
Measure
Ceftazidime-avibactam
n=516 Participants
Eligible participants who were hospitalized with gram negative infections and received at least one dose of ceftazidime-avibactam in routine clinical practice since 01-Jan-2018 were included in this chart review study.
Number of Participants Classified According to Frequency of Dosing: FAS72+ Population
0.75 grams (g)*OD
4 Participants
Number of Participants Classified According to Frequency of Dosing: FAS72+ Population
0.75 g*QOD
4 Participants
Number of Participants Classified According to Frequency of Dosing: FAS72+ Population
0.75 g*Other: Post dialysis
1 Participants
Number of Participants Classified According to Frequency of Dosing: FAS72+ Population
0.75 g*Other: each 48 h
1 Participants
Number of Participants Classified According to Frequency of Dosing: FAS72+ Population
0.75 g*TID
1 Participants
Number of Participants Classified According to Frequency of Dosing: FAS72+ Population
0.75 g*BD
13 Participants
Number of Participants Classified According to Frequency of Dosing: FAS72+ Population
0.80 g*BD
2 Participants
Number of Participants Classified According to Frequency of Dosing: FAS72+ Population
0.94 g*BD
1 Participants
Number of Participants Classified According to Frequency of Dosing: FAS72+ Population
1.00 g*OD
6 Participants
Number of Participants Classified According to Frequency of Dosing: FAS72+ Population
1.00 g*QOD
2 Participants
Number of Participants Classified According to Frequency of Dosing: FAS72+ Population
1.00 g*QID
2 Participants
Number of Participants Classified According to Frequency of Dosing: FAS72+ Population
1.00 g*Other: Post dialysis
1 Participants
Number of Participants Classified According to Frequency of Dosing: FAS72+ Population
1.00 g*TID
51 Participants
Number of Participants Classified According to Frequency of Dosing: FAS72+ Population
1.00 g*BD
19 Participants
Number of Participants Classified According to Frequency of Dosing: FAS72+ Population
1.20 g*TID
1 Participants
Number of Participants Classified According to Frequency of Dosing: FAS72+ Population
1.25 g*TID
1 Participants
Number of Participants Classified According to Frequency of Dosing: FAS72+ Population
1.50 g*OD
1 Participants
Number of Participants Classified According to Frequency of Dosing: FAS72+ Population
2.00 g*OD
7 Participants
Number of Participants Classified According to Frequency of Dosing: FAS72+ Population
2.00 g*QOD
2 Participants
Number of Participants Classified According to Frequency of Dosing: FAS72+ Population
2.00 g*QID
5 Participants
Number of Participants Classified According to Frequency of Dosing: FAS72+ Population
2.00 g*Other: Once, loading dose
2 Participants
Number of Participants Classified According to Frequency of Dosing: FAS72+ Population
2.00 g*Other: every 3 days
1 Participants
Number of Participants Classified According to Frequency of Dosing: FAS72+ Population
2.00 g*Other: once
1 Participants
Number of Participants Classified According to Frequency of Dosing: FAS72+ Population
2.00 g*TID
400 Participants
Number of Participants Classified According to Frequency of Dosing: FAS72+ Population
2.00 g*BD
29 Participants
Number of Participants Classified According to Frequency of Dosing: FAS72+ Population
2.50 g*OD
1 Participants

PRIMARY outcome

Timeframe: From start of index treatment to end of index treatment (maximum 3 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)

Population: FAS72- population included all participants with \< 72 hours exposure to ceftazidime-avibactam.

Number of participants classified according to frequency of dose (once daily \[OD\], every other day \[QOD\], each 48 hours \[h\], continuous infusion per 48 hours \[c/48 h\], three times daily \[TID\], twice daily \[BD\], four times daily \[QID\], one dose, loading dose \[an initial higher dose of a drug that may be given at the beginning of a course of treatment before dropping down to a lower maintenance dose\] etc.,) for ceftazidime-avibactam were reported in this outcome measure.

Outcome measures

Outcome measures
Measure
Ceftazidime-avibactam
n=53 Participants
Eligible participants who were hospitalized with gram negative infections and received at least one dose of ceftazidime-avibactam in routine clinical practice since 01-Jan-2018 were included in this chart review study.
Number of Participants Classified According to Frequency of Dosing: FAS72- Population
0.75 g*Other: 48 h
1 Participants
Number of Participants Classified According to Frequency of Dosing: FAS72- Population
0.94 g*QOD
1 Participants
Number of Participants Classified According to Frequency of Dosing: FAS72- Population
1.00 g*OD
2 Participants
Number of Participants Classified According to Frequency of Dosing: FAS72- Population
1.00 g*QOD
1 Participants
Number of Participants Classified According to Frequency of Dosing: FAS72- Population
1.00 g*Other: 48 h
1 Participants
Number of Participants Classified According to Frequency of Dosing: FAS72- Population
1.00 g*Other: c/48h
1 Participants
Number of Participants Classified According to Frequency of Dosing: FAS72- Population
1.00 g*TID
3 Participants
Number of Participants Classified According to Frequency of Dosing: FAS72- Population
1.87 g*BD
1 Participants
Number of Participants Classified According to Frequency of Dosing: FAS72- Population
2.00 g*OD
3 Participants
Number of Participants Classified According to Frequency of Dosing: FAS72- Population
2.00 g*QID
1 Participants
Number of Participants Classified According to Frequency of Dosing: FAS72- Population
2.00 g*Other: Loading dose
1 Participants
Number of Participants Classified According to Frequency of Dosing: FAS72- Population
2.00 g*Other: one dose
1 Participants
Number of Participants Classified According to Frequency of Dosing: FAS72- Population
2.00 g*TID
34 Participants
Number of Participants Classified According to Frequency of Dosing: FAS72- Population
2.00 g*BD
4 Participants
Number of Participants Classified According to Frequency of Dosing: FAS72- Population
3.00 g*BD
1 Participants

PRIMARY outcome

Timeframe: From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)

Population: FAS72+ population included all participants with at least 72 hours of exposure to ceftazidime-avibactam.

Total duration of administration was calculated as stop date of administration of ceftazidime-avibactam minus start date of ceftazidime-avibactam administration plus 1.

Outcome measures

Outcome measures
Measure
Ceftazidime-avibactam
n=516 Participants
Eligible participants who were hospitalized with gram negative infections and received at least one dose of ceftazidime-avibactam in routine clinical practice since 01-Jan-2018 were included in this chart review study.
Total Duration of Administration of Ceftazidime-Avibactam: FAS72+ Population
9.0 Days
Interval 2.0 to 179.0

PRIMARY outcome

Timeframe: From start of index treatment to end of index treatment (maximum 3 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)

Population: FAS72- population included all participants with \< 72 hours exposure to ceftazidime-avibactam.

Total duration of administration was calculated as stop date of administration of ceftazidime-avibactam minus start date of ceftazidime-avibactam administration plus 1.

Outcome measures

Outcome measures
Measure
Ceftazidime-avibactam
n=53 Participants
Eligible participants who were hospitalized with gram negative infections and received at least one dose of ceftazidime-avibactam in routine clinical practice since 01-Jan-2018 were included in this chart review study.
Total Duration of Administration of Ceftazidime-Avibactam: FAS72- Population
1.0 Days
Interval 1.0 to 3.0

PRIMARY outcome

Timeframe: From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)

Population: FAS72+ population included all participants with at least 72 hours of exposure to ceftazidime-avibactam. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Number of participants according to the reasons for discontinuation of ceftazidime-avibactam were reported in this outcome measure.

Outcome measures

Outcome measures
Measure
Ceftazidime-avibactam
n=506 Participants
Eligible participants who were hospitalized with gram negative infections and received at least one dose of ceftazidime-avibactam in routine clinical practice since 01-Jan-2018 were included in this chart review study.
Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72+ Population
Adverse events (AEs)
3 Participants
Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72+ Population
Perceived clinical failure/disease progression
10 Participants
Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72+ Population
Isolation of a resistant pathogen
9 Participants
Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72+ Population
Preference for empiric coverage
2 Participants
Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72+ Population
Secondary infection requiring regimen change
11 Participants
Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72+ Population
Switch to oral therapy
5 Participants
Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72+ Population
De-escalation
59 Participants
Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72+ Population
Cure
329 Participants
Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72+ Population
Death
50 Participants
Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72+ Population
Other
28 Participants

PRIMARY outcome

Timeframe: From start of index treatment to end of index treatment (maximum 3 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)

Population: FAS72- population included all participants with \< 72 hours exposure to ceftazidime-avibactam. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Number of participants according to the reasons for discontinuation of ceftazidime-avibactam were reported in this outcome measure.

Outcome measures

Outcome measures
Measure
Ceftazidime-avibactam
n=52 Participants
Eligible participants who were hospitalized with gram negative infections and received at least one dose of ceftazidime-avibactam in routine clinical practice since 01-Jan-2018 were included in this chart review study.
Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72- Population
Adverse events (AEs)
0 Participants
Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72- Population
Perceived clinical failure/disease progression
1 Participants
Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72- Population
Isolation of a resistant pathogen
6 Participants
Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72- Population
Preference for empiric coverage
1 Participants
Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72- Population
Secondary infection requiring regimen change
2 Participants
Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72- Population
Switch to oral therapy
0 Participants
Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72- Population
De-escalation
23 Participants
Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72- Population
Cure
1 Participants
Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72- Population
Death
14 Participants
Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72- Population
Other
4 Participants

PRIMARY outcome

Timeframe: From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)

Population: FAS72+ population included all participants with at least 72 hours of exposure to Ceftazidime-avibactam.

The number of participants classified according to antibiotics used concurrently with ceftazidime-avibactam were reported in this outcome measure. Participants could have received more than 1 antibiotic.

Outcome measures

Outcome measures
Measure
Ceftazidime-avibactam
n=516 Participants
Eligible participants who were hospitalized with gram negative infections and received at least one dose of ceftazidime-avibactam in routine clinical practice since 01-Jan-2018 were included in this chart review study.
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
Fluoroquinolones: Ofloxacin ear drops
1 Participants
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
Aminoglycoside: Amikacin
58 Participants
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
Aminoglycoside: Gentamicin
19 Participants
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
Aminoglycoside: Tobramycin
6 Participants
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
Amphenicol: Chloramphenicol
1 Participants
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
Carbapenems: Doripenem
1 Participants
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
Carbapenems: Ertapenem
1 Participants
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
Carbapenems: Imipenem
1 Participants
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
Carbapenems: Meropenem
28 Participants
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
Cephalosporins: Ceftazidime
4 Participants
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
Glycopeptides: Teicoplanin
18 Participants
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
Glycopeptides: Telavancin
1 Participants
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
Glycopeptides: Vancomycin
65 Participants
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
Glycylcycline: Tigecycline
49 Participants
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
Lipopeptides: Daptomycin
21 Participants
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
Macrolides: Azithromycin
4 Participants
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
Macrolides: Clarithromycin
2 Participants
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
Macrolides: Clindamycin
1 Participants
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
Macrolides: Erythromycin
6 Participants
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
Macrolides: Fidaxomicin
1 Participants
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
Monobactam: Aztreonam
104 Participants
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
Nitroimidazole: Metronidazole
60 Participants
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
Oxazolidinones: Linezolid
37 Participants
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
Oxazolidinones: Tedizolid
4 Participants
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
Penicillins: Amoxicillin
1 Participants
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
Penicillins: Ampicillin
8 Participants
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
Penicillins: Benzylpenicillin
1 Participants
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
Penicillins: Flucloxacillin
1 Participants
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
Penicillins: Ticarcillin
1 Participants
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
Penicillins and beta-lactamase inhibitors: Amoxicillin-clavulanate
1 Participants
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
Penicillins and beta-lactamase inhibitors: Ampicillin-sulbactam
1 Participants
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
Penicillins and beta-lactamase inhibitors: Piperacillin-tazobactam
5 Participants
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
Fluoroquinolones: Ciprofloxacin
15 Participants
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
Fluoroquinolones: Levofloxacin
5 Participants
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
Fluoroquinolones: Moxifloxacin
3 Participants
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
Tetracycline: Doxycycline
1 Participants
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
Other agents
123 Participants
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
Polymyxins: Colistin
60 Participants
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
Polymyxins: Polymyxin B
15 Participants
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
Sulfonamides and Trimethoprim: Trimethoprim-sulfamethoxazole
21 Participants
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
Other antibiotics: Clofazimine
1 Participants
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
Other antibiotics: Ethambutol
1 Participants
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
Other antibiotics: Fosfomycin
12 Participants
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
Other antibiotics: Isoniazid
2 Participants
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
Other antibiotics: Rifampicin
1 Participants
Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
Other antibiotics: Rifaximin
1 Participants

PRIMARY outcome

Timeframe: From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)

Population: FAS72+ population included all participants with at least 72 hours of exposure to ceftazidime-avibactam. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.

The number of participants classified according to reason for initiating specific antibiotics combined with ceftazidime-avibactam were reported in this outcome measure. One participant could have received more than 1 antibiotics and there could be more than 1 reason for initiating antibiotics.

Outcome measures

Outcome measures
Measure
Ceftazidime-avibactam
n=516 Participants
Eligible participants who were hospitalized with gram negative infections and received at least one dose of ceftazidime-avibactam in routine clinical practice since 01-Jan-2018 were included in this chart review study.
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Amikacin: Empiric treatment
7 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Amikacin: Failure of antimicrobial treatment
2 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Amikacin: Infection
30 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Amikacin: Microbiology
18 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Amikacin: Prophylaxis
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Amikacin: Other
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Amoxicillin: Microbiology
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Amoxicillin-clavulanate: Microbiology
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Ampicillin: Infection
3 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Ampicillin: Microbiology
4 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Ampicillin: Other
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Ampicillin-sulbactam: Infection
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Aztreonam: Disease progression
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Aztreonam: Empiric treatment
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Aztreonam: Failure of antimicrobial treatment
4 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Aztreonam: Infection
23 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Aztreonam: Microbiology
73 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Aztreonam: Other
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Ceftazidime: Infection
2 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Ceftazidime: Microbiology
2 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Chloramphenicol: Infection
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Ciprofloxacin: Infection
8 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Ciprofloxacin: Microbiology
6 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Ciprofloxacin: Prophylaxis
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Doripenem: Infection
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Ertapenem: Microbiology
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Gentamicin: Empiric treatment
2 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Gentamicin: Infection
5 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Gentamicin: Microbiology
13 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Imipenem: Empiric treatment
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Levofloxacin: Infection
3 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Levofloxacin: Microbiology
2 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Meropenem: Empiric treatment
3 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Meropenem: Infection
14 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Meropenem: Microbiology
9 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Meropenem: Prophylaxis
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Meropenem: Other
2 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Moxifloxacin: Infection
2 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Moxifloxacin: Microbiology
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Piperacillin-tazobactam: Empiric treatment
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Piperacillin-tazobactam: Infection
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Piperacillin-tazobactam: Microbiology
2 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Ticarcillin: Infection
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Tigecycline: Disease progression
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Tigecycline: Empiric treatment
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Tigecycline: Failure of antimicrobial treatment
2 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Tigecycline: Infection
21 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Tigecycline: Microbiology
20 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Tigecycline: Other
3 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Tobramycin: Infection
5 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Tobramycin: Other
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Polymyxins: Colistin: Disease progression
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Polymyxins: Colistin: Empiric treatment
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Polymyxins: Colistin: Infection
30 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Polymyxins: Colistin: Microbiology
27 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Polymyxins: Colistin: Other
2 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Polymyxins: Polymyxin B: Infection
6 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Polymyxins: Polymyxin B: Microbiology
9 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Sulfonamides and Trimethoprim: Trimethoprim-sulfamethoxazole: Disease progression
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Sulfonamides and Trimethoprim: Trimethoprim-sulfamethoxazole: Empiric treatment
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Sulfonamides and Trimethoprim: Trimethoprim-sulfamethoxazole: Failure of antimicrobial treatment
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Sulfonamides and Trimethoprim: Trimethoprim-sulfamethoxazole: Infection
5 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Sulfonamides and Trimethoprim: Trimethoprim-sulfamethoxazole: Microbiology
8 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Sulfonamides and Trimethoprim: Trimethoprim-sulfamethoxazole: Prophylaxis
5 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Other antibiotics: Fosfomycin: Disease progression
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Other antibiotics: Fosfomycin: Infection
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Other antibiotics: Fosfomycin: Microbiology
8 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Other antibiotics: Fosfomycin: Other
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Other antibiotics: Rifampicin: Microbiology
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Azithromycin: Infection
2 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Azithromycin: Microbiology
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Azithromycin: Other
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Benzylpenicillin: Microbiology
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Clarithromycin: Microbiology
2 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Clindamycin: Empiric treatment
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Daptomycin: Empiric treatment
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Daptomycin: Infection
16 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Daptomycin: Microbiology
2 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Daptomycin: Other
2 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Doxycycline: Infection
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Erythromycin: Infection
2 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Erythromycin: Other
4 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Fidaxomicin: Clostridium difficile
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Flucloxacillin: Infection
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Linezolid: Disease progression
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Linezolid: Empiric treatment
6 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Linezolid: Failure of antimicrobial treatment
2 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Linezolid: Infection
15 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Linezolid: Microbiology
13 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Tedizolid: Infection
2 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Tedizolid: Microbiology
2 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Teicoplanin: Clostridium difficile
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Teicoplanin: Disease progression
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Teicoplanin: Empiric treatment
2 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Teicoplanin: Infection
4 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Teicoplanin: Microbiology
7 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Teicoplanin: Prophylaxis
2 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Telavancin: Disease progression
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Vancomycin: Clostridium difficile
6 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Vancomycin: Empiric treatment
2 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Vancomycin: Infection
40 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Vancomycin: Microbiology
14 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Vancomycin: Prophylaxis
3 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Vancomycin: Other
2 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Other antibiotics: Rifaximin: Infection
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Metronidazole: Clostridium difficile
9 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Metronidazole: Empiric treatment
2 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Metronidazole: Failure of antimicrobial treatment
2 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Metronidazole: Infection
28 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Metronidazole: Microbiology
18 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Metronidazole: Prophylaxis
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Metronidazole: Other
3 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Ofloxacin ear drops: Infection
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Other antibiotics: Clofazimine: Infection
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Ethambutol: Microbiology
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Isoniazid: Microbiology
1 Participants
Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
Isoniazid: Prophylaxis
1 Participants

PRIMARY outcome

Timeframe: From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)

Population: FAS72+ population included all participants with at least 72 hours of exposure to Ceftazidime-avibactam. Here, "Number Analyzed" signifies number of participants evaluable for the specified rows.

The number of participants classified according to reason for discontinuing specific antibiotics combined with ceftazidime-avibactam were reported in this outcome measure. One participant could have received more than 1 antibiotics and there could be more than 1 reason for discontinuing antibiotics.

Outcome measures

Outcome measures
Measure
Ceftazidime-avibactam
n=516 Participants
Eligible participants who were hospitalized with gram negative infections and received at least one dose of ceftazidime-avibactam in routine clinical practice since 01-Jan-2018 were included in this chart review study.
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Amikacin: Perceived clinical failure/disease progression
4 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Amikacin: Isolation of a resistant pathogen
5 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Amikacin: Preference for empiric coverage
6 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Amikacin: Secondary infection requiring regimen change
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Amikacin: De-escalation
13 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Amikacin: Cure
15 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Amikacin: Death
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Amikacin: Other
15 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Amoxicillin: Cure
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Amoxicillin-clavulanate: Cure
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Ampicillin: Switch to oral therapy
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Ampicillin: Cure
6 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Ampicillin: Other
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Ampicillin-sulbactam: De-escalation
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Aztreonam: Perceived clinical failure/disease progression
3 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Aztreonam: Isolation of a resistant pathogen
3 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Aztreonam: Preference for empiric coverage
2 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Aztreonam: Secondary infection requiring regimen change
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Aztreonam: Switch to oral therapy
2 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Aztreonam: De-escalation
11 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Aztreonam: Cure
66 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Aztreonam: Death
11 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Aztreonam: Other
2 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Ceftazidime: De-escalation
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Ceftazidime: Cure
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Ceftazidime: Death
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Ceftazidime: Other
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Chloramphenicol: Cure
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Ciprofloxacin: Perceived clinical failure/disease progression
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Ciprofloxacin: Isolation of a resistant pathogen
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Ciprofloxacin: Preference for empiric coverage
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Ciprofloxacin: Switch to oral therapy
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Ciprofloxacin: De-escalation
3 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Ciprofloxacin: Cure
4 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Ciprofloxacin: Death
2 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Ciprofloxacin: Other
3 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Doripenem: Cure
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Ertapenem: Cure
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Gentamicin: Isolation of a resistant pathogen
4 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Gentamicin: Preference for empiric coverage
3 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Gentamicin: De-escalation
4 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Gentamicin: Cure
5 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Gentamicin: Other
4 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Imipenem: Secondary infection requiring regimen change
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Levofloxacin: Perceived clinical failure/disease progression
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Levofloxacin: Secondary infection requiring regimen change
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Levofloxacin: De-escalation
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Levofloxacin: Death
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Levofloxacin: Other
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Meropenem: AE
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Meropenem: Perceived clinical failure/disease progression
3 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Meropenem: Isolation of a resistant pathogen
5 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Meropenem: Preference for empiric coverage
3 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Meropenem: Secondary infection requiring regimen change
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Meropenem: Switch to oral therapy
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Meropenem: De-escalation
6 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Meropenem: Cure
5 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Meropenem: Death
2 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Meropenem: Other
3 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Moxifloxacin: Switch to oral therapy
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Moxifloxacin: Cure
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Moxifloxacin: Other
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Piperacillin-tazobactam: Preference for empiric coverage
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Piperacillin-tazobactam: Secondary infection requiring regimen change
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Piperacillin-tazobactam: De-escalation
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Piperacillin-tazobactam: Cure
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Ticarcillin: Cure
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Tigecycline: AE
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Tigecycline: Perceived clinical failure/disease progression
4 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Tigecycline: Isolation of a resistant pathogen
3 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Tigecycline: De-escalation
8 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Tigecycline: Cure
23 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Tigecycline: Death
9 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Tigecycline: Other
5 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Tobramycin: Preference for empiric coverage
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Tobramycin: Secondary infection requiring regimen change
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Tobramycin: Cure
3 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Tobramycin: Other
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Polymyxins: Colistin: AE
3 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Polymyxins: Colistin: Perceived clinical failure/disease progression
2 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Polymyxins: Colistin: Isolation of a resistant pathogen
6 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Polymyxins: Colistin: Preference for empiric coverage
2 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Polymyxins: Colistin: De-escalation
15 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Polymyxins: Colistin: Cure
19 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Polymyxins: Colistin: Death
11 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Polymyxins: Colistin: Other
5 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Polymyxins: Polymyxin B: Perceived clinical failure/disease progression
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Polymyxins: Polymyxin B: Isolation of a resistant pathogen
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Polymyxins: Polymyxin B: De-escalation
6 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Polymyxins: Polymyxin B: Cure
4 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Polymyxins: Polymyxin B: Death
2 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Polymyxins: Polymyxin B: Other
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Sulfonamides and Trimethoprim: Trimethoprim-sulfamethoxazole (sulfa) : AE
3 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Sulfonamides and Trimethoprim: Trimethoprim-sulfa: Perceived clinical failure/disease progression
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Sulfonamides and Trimethoprim: Trimethoprim-sulfamethoxazole: Preference for empiric coverage
2 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Sulfonamides and Trimethoprim: Trimethoprim-sulfa: Secondary infection requiring regimen change
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Sulfonamides and Trimethoprim: Trimethoprim-sulfamethoxazole: De-escalation
2 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Sulfonamides and Trimethoprim: Trimethoprim-sulfamethoxazole: Cure
7 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Sulfonamides and Trimethoprim: Trimethoprim-sulfamethoxazole: Death
2 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Sulfonamides and Trimethoprim: Trimethoprim-sulfamethoxazole: Other
3 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Fosfomycin: Perceived clinical failure/disease progression
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Fosfomycin: Isolation of a resistant pathogen
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Fosfomycin: De-escalation
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Fosfomycin: Cure
5 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Fosfomycin: Death
2 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Rifampicin: Other
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Azithromycin: Perceived clinical failure/disease progression
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Azithromycin: Preference for empiric coverage
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Azithromycin: Other
2 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Benzylpenicillin: Cure
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Clarithromycin: De-escalation
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Clarithromycin: Cure
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Clindamycin: Preference for empiric coverage
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Daptomycin: AE
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Daptomycin: Perceived clinical failure/disease progression
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Daptomycin: Isolation of a resistant pathogen
4 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Daptomycin: Switch to oral therapy
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Daptomycin: De-escalation
5 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Daptomycin: Cure
5 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Daptomycin: Death
2 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Daptomycin: Other
3 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Doxycycline: Other
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Erythromycin: De-escalation
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Erythromycin: Cure
2 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Erythromycin: Death
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Erythromycin: Other
2 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Fidaxomicin: Cure
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Flucloxacillin: Preference for empiric coverage
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Linezolid: AE
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Linezolid: Perceived clinical failure/disease progression
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Linezolid: Isolation of a resistant pathogen
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Linezolid: Preference for empiric coverage
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Linezolid: Secondary infection requiring regimen change
2 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Linezolid: Switch to oral therapy
2 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Linezolid: De-escalation
4 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Linezolid: Cure
18 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Linezolid: Death
8 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Tedizolid: Perceived clinical failure/disease progression
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Tedizolid: Cure
3 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Teicoplanin: Secondary infection requiring regimen change
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Teicoplanin: De-escalation
2 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Teicoplanin: Cure
7 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Teicoplanin: Death
2 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Teicoplanin: Other
6 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Telavancin: Cure
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Vancomycin: AE
3 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Vancomycin: Perceived clinical failure/disease progression
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Vancomycin: Isolation of a resistant pathogen
5 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Vancomycin: Preference for empiric coverage
6 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Vancomycin: Secondary infection requiring regimen change
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Vancomycin: Switch to oral therapy
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Vancomycin: De-escalation
10 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Vancomycin: Cure
30 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Vancomycin: Death
2 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Vancomycin: Other
8 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Rifaximin: Cure
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Metronidazole: Perceived clinical failure/disease progression
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Metronidazole: Preference for empiric coverage
4 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Metronidazole: De-escalation
8 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Metronidazole: Cure
32 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Metronidazole: Death
7 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Metronidazole: Other
11 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Ofloxacin ear drops: Cure
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Clofazimine: Other
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Ethambutol: Other
1 Participants
Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
Isoniazid: Other
2 Participants

PRIMARY outcome

Timeframe: From end of index therapy up to 60 days after hospital discharge, in-hospital death, withdrawal from study, or lost to follow-up, whichever occurred first maximum of 464 days (from the data evaluated in approximately 40 months of the study)

Population: MOD population included all participants with at least 72 hours exposure to ceftazidime-avibactam, identification of one or more pathogens before the start of ceftazidime-avibactam treatment, and at least one non-missing microbiological outcome. Not all participants of MOD population had data collected after end of ceftazidime-avibactam therapy. Hence, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

The number of participants whose samples were taken for clinical microbiological evaluation after end of ceftazidime-avibactam therapy were reported in this outcome measure.

Outcome measures

Outcome measures
Measure
Ceftazidime-avibactam
n=20 Participants
Eligible participants who were hospitalized with gram negative infections and received at least one dose of ceftazidime-avibactam in routine clinical practice since 01-Jan-2018 were included in this chart review study.
Number of Participants Whose Samples Were Taken for Clinical Microbiological Evaluation After End of Ceftazidime-Avibactam Therapy: Microbiology Outcomes Dataset (MOD) Population
20 Participants

PRIMARY outcome

Timeframe: From end of index therapy up to 60 days after hospital discharge, in-hospital death, withdrawal from study, or lost to follow-up, whichever occurred first maximum of 464 days (from the data evaluated in approximately 40 months of the study)

Population: MOD population included all participants with at least 72 hours exposure to ceftazidime-avibactam, identification of one or more pathogens before the start of ceftazidime-avibactam treatment, and at least one non-missing microbiological outcome. Not all participants of MOD population had data collected after end of ceftazidime-avibactam therapy. Hence, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

The number of participants classified according to the type of specimen taken for clinical microbiological evaluation after end of ceftazidime-avibactam therapy were reported in this outcome measure. More than 1 type of specimen could have been taken from 1 participant.

Outcome measures

Outcome measures
Measure
Ceftazidime-avibactam
n=20 Participants
Eligible participants who were hospitalized with gram negative infections and received at least one dose of ceftazidime-avibactam in routine clinical practice since 01-Jan-2018 were included in this chart review study.
Number of Participants Classified According to Type of Specimen Taken for Clinical Microbiological Evaluation After End of Ceftazidime-Avibactam Therapy: MOD Population
Blood
10 Participants
Number of Participants Classified According to Type of Specimen Taken for Clinical Microbiological Evaluation After End of Ceftazidime-Avibactam Therapy: MOD Population
Urine
4 Participants
Number of Participants Classified According to Type of Specimen Taken for Clinical Microbiological Evaluation After End of Ceftazidime-Avibactam Therapy: MOD Population
Bronchoalveolar lavage
4 Participants
Number of Participants Classified According to Type of Specimen Taken for Clinical Microbiological Evaluation After End of Ceftazidime-Avibactam Therapy: MOD Population
Sputum
5 Participants
Number of Participants Classified According to Type of Specimen Taken for Clinical Microbiological Evaluation After End of Ceftazidime-Avibactam Therapy: MOD Population
Abscess drainage
1 Participants
Number of Participants Classified According to Type of Specimen Taken for Clinical Microbiological Evaluation After End of Ceftazidime-Avibactam Therapy: MOD Population
Swab
3 Participants
Number of Participants Classified According to Type of Specimen Taken for Clinical Microbiological Evaluation After End of Ceftazidime-Avibactam Therapy: MOD Population
Surgical/biopsy specimen
1 Participants
Number of Participants Classified According to Type of Specimen Taken for Clinical Microbiological Evaluation After End of Ceftazidime-Avibactam Therapy: MOD Population
Other
5 Participants

PRIMARY outcome

Timeframe: After treatment initiation up to 60 days post hospital discharge, in-hospital death, withdrawal from the study, or lost to follow-up, whichever occurred first maximum of 464 days (from the data evaluated in approximately 40 months of the study)

Population: MOD population included all participants with at least 72 hours exposure to ceftazidime-avibactam, identification of one or more pathogens before the start of ceftazidime-avibactam treatment, and at least one non-missing microbiological outcome. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

The number of participants classified according to the pathogens identified from the microbiological culture after treatment initiation were reported in this outcome measure.

Outcome measures

Outcome measures
Measure
Ceftazidime-avibactam
n=69 Participants
Eligible participants who were hospitalized with gram negative infections and received at least one dose of ceftazidime-avibactam in routine clinical practice since 01-Jan-2018 were included in this chart review study.
Number of Participants Classified According to the Pathogens Identified From the Microbiological Culture After Treatment Initiation: MOD Population
Gram-negative: Escherichia coli
4 Participants
Number of Participants Classified According to the Pathogens Identified From the Microbiological Culture After Treatment Initiation: MOD Population
Gram-negative: Klebsiella pneumoniae
15 Participants
Number of Participants Classified According to the Pathogens Identified From the Microbiological Culture After Treatment Initiation: MOD Population
Gram-negative: Proteus mirabilis
1 Participants
Number of Participants Classified According to the Pathogens Identified From the Microbiological Culture After Treatment Initiation: MOD Population
Gram-negative: Acinetobacter baumannii
6 Participants
Number of Participants Classified According to the Pathogens Identified From the Microbiological Culture After Treatment Initiation: MOD Population
Gram-negative: Enterobacter cloacae
2 Participants
Number of Participants Classified According to the Pathogens Identified From the Microbiological Culture After Treatment Initiation: MOD Population
Gram-negative: Enterobacter species (spp)
1 Participants
Number of Participants Classified According to the Pathogens Identified From the Microbiological Culture After Treatment Initiation: MOD Population
Gram-negative: Serratia spp
2 Participants
Number of Participants Classified According to the Pathogens Identified From the Microbiological Culture After Treatment Initiation: MOD Population
Gram-negative: Morganella morganii
1 Participants
Number of Participants Classified According to the Pathogens Identified From the Microbiological Culture After Treatment Initiation: MOD Population
Gram-negative: Pseudomonas aeruginosa
8 Participants
Number of Participants Classified According to the Pathogens Identified From the Microbiological Culture After Treatment Initiation: MOD Population
Gram-negative: Pseudomonas spp
2 Participants
Number of Participants Classified According to the Pathogens Identified From the Microbiological Culture After Treatment Initiation: MOD Population
Gram-negative: Other
8 Participants
Number of Participants Classified According to the Pathogens Identified From the Microbiological Culture After Treatment Initiation: MOD Population
Gram-positive: Staphylococcus spp
6 Participants
Number of Participants Classified According to the Pathogens Identified From the Microbiological Culture After Treatment Initiation: MOD Population
Gram-positive: Enterococcus spp
14 Participants
Number of Participants Classified According to the Pathogens Identified From the Microbiological Culture After Treatment Initiation: MOD Population
Gram-positive: Other
3 Participants
Number of Participants Classified According to the Pathogens Identified From the Microbiological Culture After Treatment Initiation: MOD Population
Anaerobes: Clostridium spp
1 Participants
Number of Participants Classified According to the Pathogens Identified From the Microbiological Culture After Treatment Initiation: MOD Population
Other Bacterial Agent
1 Participants

PRIMARY outcome

Timeframe: After treatment initiation up to 60 days post hospital discharge, in-hospital death, withdrawal from the study, or lost to follow-up, whichever occurred first maximum of 464 days (from the data evaluated in approximately 40 months of the study)

Population: FAS72+ population included all participants with at least 72 hours of exposure to Ceftazidime-avibactam. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

The number of gram-negative pathogens according to the susceptibility to specific antibiotics after treatment initiation were reported in this outcome measure.

Outcome measures

Outcome measures
Measure
Ceftazidime-avibactam
n=52 Pathogens
Eligible participants who were hospitalized with gram negative infections and received at least one dose of ceftazidime-avibactam in routine clinical practice since 01-Jan-2018 were included in this chart review study.
Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
Penicillins and beta-lactamase inhibitors
30 Pathogens
Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
Aminoglycosides
39 Pathogens
Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
Amphenicol
2 Pathogens
Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
Carbapenems
39 Pathogens
Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
Carbapenems: Doripenem
13 Pathogens
Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
Carbapenems: Ertapenem
17 Pathogens
Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
Carbapenems: Imipenem
31 Pathogens
Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
Carbapenems: Meropenem
36 Pathogens
Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
Cephalosporins
35 Pathogens
Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
Cephalosporins: Cefalexin
0 Pathogens
Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
Cephalosporins: Cefazolin
0 Pathogens
Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
Cephalosporins: Cefepime
12 Pathogens
Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
Cephalosporins: Cefixime
1 Pathogens
Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
Cephalosporins: Cefotaxime
13 Pathogens
Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
Cephalosporins: Cefoxitin
1 Pathogens
Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
Cephalosporins: Cefpodoxime
0 Pathogens
Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
Cephalosporins: Ceftaroline
0 Pathogens
Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
Cephalosporins: Ceftazidime
27 Pathogens
Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
Cephalosporins: Ceftriaxone
7 Pathogens
Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
Cephalosporins: Cefuroxime
2 Pathogens
Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
Cephalosporin/beta-lactamase inhibitor
6 Pathogens
Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
Cephalosporin/beta-lactamase inhibitor: Ceftazidime/avibactam
5 Pathogens
Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
Cephalosporin/beta-lactamase inhibitor: Cefoperazone/sulbactam
0 Pathogens
Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
Cephalosporin/beta-lactamase inhibitor: Ceftolozane/tazobactam
1 Pathogens
Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
Glycopeptides
0 Pathogens
Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
Glycylcycline
4 Pathogens
Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
Lipopeptides
0 Pathogens
Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
Macrolides
0 Pathogens
Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
Monobactam
9 Pathogens
Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
Nitroimidazole
0 Pathogens
Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
Oxazolidinones
0 Pathogens
Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
Penicillins
2 Pathogens
Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
Penicillins and beta-lactamase inhibitors: Ampicillin-sulbactam
3 Pathogens
Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
Penicillins and beta-lactamase inhibitors: Amoxicillin-clavulanate
15 Pathogens
Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
Penicillins and beta-lactamase inhibitors: Piperacillin-tazobactam
14 Pathogens
Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
Penicillins and beta-lactamase inhibitors: Ticarcillin-clavulanate
3 Pathogens
Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
Fluoroquinolones
40 Pathogens
Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
Streptogramins
0 Pathogens
Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
Tetracycline
0 Pathogens
Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
Other Agents
13 Pathogens
Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
Other Agents: Colistin
7 Pathogens
Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
Other Agents: Trimethoprim
0 Pathogens
Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
Other Agents: Trimethoprim-sulfamethoxazole
6 Pathogens
Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
Other Agents: Fosfomycin
1 Pathogens
Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
Other Agents: Nitrofurantoin
0 Pathogens

PRIMARY outcome

Timeframe: After treatment initiation up to 60 days post hospital discharge, in-hospital death, withdrawal from the study, or lost to follow-up, whichever occurred first maximum of 464 days (from the data evaluated in approximately 40 months of the study)

Population: FAS72+ population included all participants with at least 72 hours of exposure to Ceftazidime-avibactam. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Multi-drug resistance was defined as the isolate being non-susceptible to at least one agent in more than or equal to (\>=) 3 antimicrobial categories, excluding the therapeutic classes to which the pathogen was intrinsically resistant. The number of gram-negative pathogens classified according to the antibiotic resistance to specified antibiotics after treatment initiation were reported in this outcome measure.

Outcome measures

Outcome measures
Measure
Ceftazidime-avibactam
n=26 Pathogens
Eligible participants who were hospitalized with gram negative infections and received at least one dose of ceftazidime-avibactam in routine clinical practice since 01-Jan-2018 were included in this chart review study.
Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
Aminoglycosides
21 Pathogens
Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
Amphenicol
2 Pathogens
Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
Carbapenems
25 Pathogens
Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
Carbapenems: Doripenem
13 Pathogens
Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
Carbapenems: Ertapenem
12 Pathogens
Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
Carbapenems: Imipenem
20 Pathogens
Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
Carbapenems: Meropenem
25 Pathogens
Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
Cephalosporins
24 Pathogens
Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
Cephalosporins: Cefalexin
0 Pathogens
Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
Cephalosporins: Cefazolin
0 Pathogens
Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
Cephalosporins: Cefepime
6 Pathogens
Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
Cephalosporins: Cefixime
1 Pathogens
Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
Cephalosporins: Cefotaxime
9 Pathogens
Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
Cephalosporins: Cefoxitin
1 Pathogens
Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
Cephalosporins: Cefpodoxime
0 Pathogens
Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
Cephalosporins: Ceftaroline
0 Pathogens
Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
Cephalosporins: Ceftazidime
24 Pathogens
Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
Cephalosporins: Ceftriaxone
6 Pathogens
Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
Cephalosporins: Cefuroxime
1 Pathogens
Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
Cephalosporin/beta-lactamase inhibitor
4 Pathogens
Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
Cephalosporin/beta-lactamase inhibitor: Ceftazidime/avibactam
4 Pathogens
Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
Cephalosporin/beta-lactamase inhibitor: Cefoperazone/sulbactam
0 Pathogens
Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
Cephalosporin/beta-lactamase inhibitor: Ceftolozane/tazobactam
0 Pathogens
Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
Cephalosporin/beta-lactamase inhibitor: Glycopeptides
0 Pathogens
Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
Glycylcycline
2 Pathogens
Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
Lipopeptides
0 Pathogens
Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
Macrolides
0 Pathogens
Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
Monobactam
9 Pathogens
Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
Nitroimidazole
0 Pathogens
Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
Oxazolidinones
0 Pathogens
Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
Penicillins
1 Pathogens
Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
Penicillins and beta-lactamase inhibitors
21 Pathogens
Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
Penicillins and beta-lactamase inhibitors: Ampicillin-sulbactam
1 Pathogens
Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
Penicillins and beta-lactamase inhibitors: Amoxicillin-clavulanate
12 Pathogens
Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
Penicillins and beta-lactamase inhibitors: Piperacillin-tazobactam
8 Pathogens
Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
Penicillins and beta-lactamase inhibitors: Ticarcillin-clavulanate
3 Pathogens
Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
Fluoroquinolones
24 Pathogens
Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
Streptogramins
0 Pathogens
Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
Tetracycline
0 Pathogens
Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
Other Agents
5 Pathogens
Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
Other Agents: Colistin
4 Pathogens
Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
Other Agents: Trimethoprim
0 Pathogens
Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
Other Agents: Trimethoprim-sulfamethoxazole
1 Pathogens
Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
Other Agents: Fosfomycin
0 Pathogens
Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
Other Agents: Nitrofurantoin
0 Pathogens

PRIMARY outcome

Timeframe: At initial hospitalization (from the data evaluated in approximately 40 months of this study)

Population: COD population included all participants with at least 72 hours exposure to ceftazidime-avibactam and at least one non-missing clinical outcome.

The number of participants classified according to type of clinical evaluation outcome as success, failure or indeterminate. Success: resolution of all signs and symptoms of infection with no need for escalation of antimicrobials for gram-negative coverage. Failure: inadequate response to ceftazidime-avibactam therapy or resistant, worsening, or new recurrent signs and symptoms at the end of ceftazidime-avibactam therapy. Indeterminate: there was not enough information to conclude whether the antibiotic regimen containing ceftazidime-avibactam was a clinical failure or a success.

Outcome measures

Outcome measures
Measure
Ceftazidime-avibactam
n=516 Participants
Eligible participants who were hospitalized with gram negative infections and received at least one dose of ceftazidime-avibactam in routine clinical practice since 01-Jan-2018 were included in this chart review study.
Number of Participants Classified According to Type of Clinical Evaluation Outcome at Initial Hospitalization: Clinical Outcomes Dataset (COD) Population
Success
399 Participants
Number of Participants Classified According to Type of Clinical Evaluation Outcome at Initial Hospitalization: Clinical Outcomes Dataset (COD) Population
Failure
60 Participants
Number of Participants Classified According to Type of Clinical Evaluation Outcome at Initial Hospitalization: Clinical Outcomes Dataset (COD) Population
Indeterminate
57 Participants

PRIMARY outcome

Timeframe: 60 days after hospital discharge (from the data evaluated in approximately 40 months of this study)

Population: COD population included all participants with at least 72 hours exposure to ceftazidime-avibactam and at least one non-missing clinical outcome. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

The number of participants classified according to type of clinical evaluation outcome as success, failure or indeterminate. Success: resolution of all signs and symptoms of infection with no need for escalation of antimicrobials for gram-negative coverage. Failure: inadequate response to ceftazidime-avibactam therapy or resistant, worsening, or new recurrent signs and symptoms at the end of ceftazidime-avibactam therapy. Indeterminate: there was not enough information to conclude whether the antibiotic regimen containing ceftazidime-avibactam was a clinical failure or a success.

Outcome measures

Outcome measures
Measure
Ceftazidime-avibactam
n=317 Participants
Eligible participants who were hospitalized with gram negative infections and received at least one dose of ceftazidime-avibactam in routine clinical practice since 01-Jan-2018 were included in this chart review study.
Number of Participants Classified According to Type of Clinical Evaluation Outcome 60 Days Post-Discharge: Clinical Outcomes Dataset (COD) Population
Success
266 Participants
Number of Participants Classified According to Type of Clinical Evaluation Outcome 60 Days Post-Discharge: Clinical Outcomes Dataset (COD) Population
Failure
27 Participants
Number of Participants Classified According to Type of Clinical Evaluation Outcome 60 Days Post-Discharge: Clinical Outcomes Dataset (COD) Population
Indeterminate
24 Participants

PRIMARY outcome

Timeframe: 60 days post treatment (from the data evaluated in approximately 40 months of this study)

Population: COD population included all participants with at least 72 hours exposure to ceftazidime-avibactam and at least one non-missing clinical outcome. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

The number of participants classified according to type of clinical evaluation outcome as success, failure or indeterminate. Success: resolution of all signs and symptoms of infection with no need for escalation of antimicrobials for gram-negative coverage. Failure: inadequate response to ceftazidime-avibactam therapy or resistant, worsening, or new recurrent signs and symptoms at the end of ceftazidime-avibactam therapy. Indeterminate: there was not enough information to conclude whether the antibiotic regimen containing ceftazidime-avibactam was a clinical failure or a success.

Outcome measures

Outcome measures
Measure
Ceftazidime-avibactam
n=374 Participants
Eligible participants who were hospitalized with gram negative infections and received at least one dose of ceftazidime-avibactam in routine clinical practice since 01-Jan-2018 were included in this chart review study.
Number of Participants Classified According to Type of Clinical Evaluation Outcome 60 Days Post-Treatment: Clinical Outcomes Dataset (COD) Population
Success
311 Participants
Number of Participants Classified According to Type of Clinical Evaluation Outcome 60 Days Post-Treatment: Clinical Outcomes Dataset (COD) Population
Failure
32 Participants
Number of Participants Classified According to Type of Clinical Evaluation Outcome 60 Days Post-Treatment: Clinical Outcomes Dataset (COD) Population
Indeterminate
31 Participants

PRIMARY outcome

Timeframe: Up to 14 days post first dose of ceftazidime-avibactam (from the data evaluated in approximately 40 months of the study)

Population: Planned analysis of this outcome measure was cancelled on approval of Scientific Steering Committee as few participants had microbiological cultures after the start of ceftazidime-avibactam.

The number of participants with microbiological treatment outcome as success were reported in this outcome measure. Success was defined as: absence of causative pathogen from appropriately obtained specimens at the site of infection.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 90 days prior to index date (from the data evaluated in approximately 40 months of this study)

Population: FAS72+ population included all participants with at least 72 hours of exposure to ceftazidime-avibactam.

The number of participants classified according to antibiotics used (Yes or No) for current infection before ceftazidime-avibactam were reported in this outcome measure.

Outcome measures

Outcome measures
Measure
Ceftazidime-avibactam
n=516 Participants
Eligible participants who were hospitalized with gram negative infections and received at least one dose of ceftazidime-avibactam in routine clinical practice since 01-Jan-2018 were included in this chart review study.
Number of Participants Classified According to Antibiotics Used for Current Infection Before Ceftazidime-Avibactam: FAS72+ Population
Yes
397 Participants
Number of Participants Classified According to Antibiotics Used for Current Infection Before Ceftazidime-Avibactam: FAS72+ Population
No
119 Participants

PRIMARY outcome

Timeframe: Up to 90 days prior to index date (from the data evaluated in approximately 40 months of this study)

Population: FAS72+ population included all participants with at least 72 hours of exposure to Ceftazidime-avibactam. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

The number of participants classified according to reason for discontinuing for prior antibiotic therapy were reported in this outcome measure. One participant could have more than 1 reason of discontinuation for prior antibiotic therapy.

Outcome measures

Outcome measures
Measure
Ceftazidime-avibactam
n=389 Participants
Eligible participants who were hospitalized with gram negative infections and received at least one dose of ceftazidime-avibactam in routine clinical practice since 01-Jan-2018 were included in this chart review study.
Number of Participants Classified According to Reason for Discontinuation for Prior Antibiotic Therapy: FAS72+ Population
AE
11 Participants
Number of Participants Classified According to Reason for Discontinuation for Prior Antibiotic Therapy: FAS72+ Population
Perceived clinical failure/disease progression
134 Participants
Number of Participants Classified According to Reason for Discontinuation for Prior Antibiotic Therapy: FAS72+ Population
Isolation of a resistant pathogen
236 Participants
Number of Participants Classified According to Reason for Discontinuation for Prior Antibiotic Therapy: FAS72+ Population
Preference for empiric coverage
32 Participants
Number of Participants Classified According to Reason for Discontinuation for Prior Antibiotic Therapy: FAS72+ Population
Secondary infection requiring regimen change
35 Participants
Number of Participants Classified According to Reason for Discontinuation for Prior Antibiotic Therapy: FAS72+ Population
Switch to oral therapy
4 Participants
Number of Participants Classified According to Reason for Discontinuation for Prior Antibiotic Therapy: FAS72+ Population
De-escalation
58 Participants
Number of Participants Classified According to Reason for Discontinuation for Prior Antibiotic Therapy: FAS72+ Population
Cure
53 Participants
Number of Participants Classified According to Reason for Discontinuation for Prior Antibiotic Therapy: FAS72+ Population
Death
11 Participants
Number of Participants Classified According to Reason for Discontinuation for Prior Antibiotic Therapy: FAS72+ Population
Other
69 Participants

PRIMARY outcome

Timeframe: During index hospitalization, maximum of 418 days (from the data evaluated in approximately 40 months of this study)

Population: FAS72+ population included all participants with at least 72 hours of exposure to Ceftazidime-avibactam.

In hospital-mortality was defined as deaths occurring after treatment initiation but before hospital discharge. The percentage of participants who died during index hospitalization were reported in this outcome measure.

Outcome measures

Outcome measures
Measure
Ceftazidime-avibactam
n=516 Participants
Eligible participants who were hospitalized with gram negative infections and received at least one dose of ceftazidime-avibactam in routine clinical practice since 01-Jan-2018 were included in this chart review study.
Percentage of Participants Who Died During Index Hospitalization
23.1 Percentage of participants
Interval 19.5 to 26.9

PRIMARY outcome

Timeframe: From index treatment up to 30 days post hospital discharge, maximum of 434 days (from the data evaluated in approximately 40 months of this study)

Population: FAS72+ population included all participants with at least 72 hours of exposure to Ceftazidime-avibactam.

30-day mortality was defined as deaths occurred from index treatment up to within 30 days after hospital discharge including in-hospital mortality.

Outcome measures

Outcome measures
Measure
Ceftazidime-avibactam
n=516 Participants
Eligible participants who were hospitalized with gram negative infections and received at least one dose of ceftazidime-avibactam in routine clinical practice since 01-Jan-2018 were included in this chart review study.
Percentage of Participants Who Died Within the 30 Days After Hospital Discharge (Including In-Hospital Mortality): FAS72+ Population
24.6 Percentage of participants
Interval 21.0 to 28.6

PRIMARY outcome

Timeframe: From index treatment up to 60 days post hospital discharge, maximum of 434 days (from the data evaluated in approximately 40 months of this study)

Population: FAS72+ population included all participants with at least 72 hours of exposure to Ceftazidime-avibactam.

60-day mortality was defined as deaths occurred from index treatment up to within 60 days after hospital discharge including in-hospital mortality.

Outcome measures

Outcome measures
Measure
Ceftazidime-avibactam
n=516 Participants
Eligible participants who were hospitalized with gram negative infections and received at least one dose of ceftazidime-avibactam in routine clinical practice since 01-Jan-2018 were included in this chart review study.
Percentage of Participants Who Died Within 60 Days After Hospital Discharge (Including In-Hospital Mortality): FAS72+ Population
27.9 Percentage of participants
Interval 24.1 to 32.0

PRIMARY outcome

Timeframe: From index date up to 60 days after hospital discharge, in-hospital death, withdrawal from the study, or lost to follow-up, whichever occurred first maximum of 464 days (from the data evaluated in approximately 40 months of the study)

Population: FAS population included all enrolled participants meeting the study eligibility criteria.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. AE included both SAEs and non-SAEs. SAE was defined as any untoward medical occurrence at any dose that: resulted in death, was life-threatening; resulted in persistent or significant disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required hospitalization or prolongation of existing hospitalization. Only AEs and SAEs with explicit attribution to ceftazidime-avibactam that appeared in the reviewed information and scenarios involving drug exposure to ceftazidime-avibactam, which included exposure during pregnancy, exposure during breastfeeding, medication error, overdose, misuse, extravasation, lack of efficacy and occupational exposure associated with the use of ceftazidime-avibactam were collected in the study.

Outcome measures

Outcome measures
Measure
Ceftazidime-avibactam
n=569 Participants
Eligible participants who were hospitalized with gram negative infections and received at least one dose of ceftazidime-avibactam in routine clinical practice since 01-Jan-2018 were included in this chart review study.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any adverse event
6 Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any serious adverse event
5 Participants

PRIMARY outcome

Timeframe: From index date up to hospital discharge, in-hospital death, withdrawal from the study, or lost to follow-up, whichever occurred first maximum of 418 days (from the data evaluated in approximately 40 months of the study)

Population: FAS72+ population included all participants with at least 72 hours of exposure to Ceftazidime-avibactam. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Hospital length of stay (LOS) was defined as date of hospital discharge minus date of hospital admission plus 1. The duration of hospital stay of participants were reported in this outcome measure.

Outcome measures

Outcome measures
Measure
Ceftazidime-avibactam
n=514 Participants
Eligible participants who were hospitalized with gram negative infections and received at least one dose of ceftazidime-avibactam in routine clinical practice since 01-Jan-2018 were included in this chart review study.
Duration of Hospital Stay: FAS72+ Population
36.0 Days
Interval 3.0 to 418.0

PRIMARY outcome

Timeframe: During index hospitalization, maximum up to 418 days (from the data evaluated in approximately 40 months of the study)

Population: FAS72+ population included all participants with at least 72 hours of exposure to Ceftazidime-avibactam. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Duration of ICU stay was defined as date of ICU discharge minus date of ICU admission plus 1. The total duration of ICU stay of participants were reported in this outcome measure.

Outcome measures

Outcome measures
Measure
Ceftazidime-avibactam
n=275 Participants
Eligible participants who were hospitalized with gram negative infections and received at least one dose of ceftazidime-avibactam in routine clinical practice since 01-Jan-2018 were included in this chart review study.
Total Duration of ICU Stay: FAS72+ Population
24.0 Days
Interval 1.0 to 405.0

PRIMARY outcome

Timeframe: Up to 30 days after initial discharge (from the data evaluated in approximately 40 months of the study)

Population: FAS72+ population included all participants with at least 72 hours of exposure to Ceftazidime-avibactam.

The number of participants readmitted to the hospital during the 30 days after initial discharge were reported in this outcome measure.

Outcome measures

Outcome measures
Measure
Ceftazidime-avibactam
n=516 Participants
Eligible participants who were hospitalized with gram negative infections and received at least one dose of ceftazidime-avibactam in routine clinical practice since 01-Jan-2018 were included in this chart review study.
Number of Participants Readmitted to the Hospital During the 30 Days After Initial Discharge: FAS72+ Population
111 Participants

PRIMARY outcome

Timeframe: Up to 60 days after initial discharge (from the data evaluated in approximately 40 months of the study)

Population: FAS72+ population included all participants with at least 72 hours of exposure to Ceftazidime-avibactam.

The number of participants readmitted to the hospital during the 60 days after initial discharge were reported in this outcome measure.

Outcome measures

Outcome measures
Measure
Ceftazidime-avibactam
n=516 Participants
Eligible participants who were hospitalized with gram negative infections and received at least one dose of ceftazidime-avibactam in routine clinical practice since 01-Jan-2018 were included in this chart review study.
Number of Participants Readmitted to the Hospital During the 60 Days After Initial Discharge: FAS72+ Population
53 Participants

PRIMARY outcome

Timeframe: At readmission to the hospital, up to maximum of 60 days post initial hospital discharge (from the data evaluated in approximately 40 months of the study)

Population: FAS72+ population included all participants with at least 72 hours of exposure to Ceftazidime-avibactam. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

The number of participants classified according to the reason for readmission to the hospital were reported in this outcome measure. One participant could have more than 1 reason for readmission to the hospital.

Outcome measures

Outcome measures
Measure
Ceftazidime-avibactam
n=137 Participants
Eligible participants who were hospitalized with gram negative infections and received at least one dose of ceftazidime-avibactam in routine clinical practice since 01-Jan-2018 were included in this chart review study.
Number of Participants Classified According to Reason for Readmission to the Hospital: FAS72+ Population
Secondary infection
17 Participants
Number of Participants Classified According to Reason for Readmission to the Hospital: FAS72+ Population
Unrelated to the infection
98 Participants
Number of Participants Classified According to Reason for Readmission to the Hospital: FAS72+ Population
Infection recurrence
25 Participants
Number of Participants Classified According to Reason for Readmission to the Hospital: FAS72+ Population
Unknown
6 Participants

PRIMARY outcome

Timeframe: During index hospitalization maximum of 418 days (from the data evaluated in approximately 40 months of the study)

Population: FAS72+ population included all participants with at least 72 hours of exposure to Ceftazidime-avibactam.

The number of participants classified according to the healthcare resource utilization during the hospitalization were reported in this outcome measure. One participant could have utilized more than 1 healthcare resource during hospitalization.

Outcome measures

Outcome measures
Measure
Ceftazidime-avibactam
n=516 Participants
Eligible participants who were hospitalized with gram negative infections and received at least one dose of ceftazidime-avibactam in routine clinical practice since 01-Jan-2018 were included in this chart review study.
Number of Participants Classified According to the Healthcare Resource Utilized During the Hospitalization: FAS72+ Population
Surgical intervention
169 Participants
Number of Participants Classified According to the Healthcare Resource Utilized During the Hospitalization: FAS72+ Population
Percutaneous procedures
149 Participants
Number of Participants Classified According to the Healthcare Resource Utilized During the Hospitalization: FAS72+ Population
Other
73 Participants
Number of Participants Classified According to the Healthcare Resource Utilized During the Hospitalization: FAS72+ Population
Mechanical ventilation
161 Participants
Number of Participants Classified According to the Healthcare Resource Utilized During the Hospitalization: FAS72+ Population
Hemodialysis
80 Participants
Number of Participants Classified According to the Healthcare Resource Utilized During the Hospitalization: FAS72+ Population
CT/MRI imaging
273 Participants
Number of Participants Classified According to the Healthcare Resource Utilized During the Hospitalization: FAS72+ Population
Tracheostomy
83 Participants

PRIMARY outcome

Timeframe: During index hospitalization maximum of 418 days (from the data evaluated in approximately 40 months of the study)

Population: FAS72+ population included all participants with at least 72 hours of exposure to Ceftazidime-avibactam. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

The number of participants classified according to all wards attended during hospitalization were reported in this outcome measure.

Outcome measures

Outcome measures
Measure
Ceftazidime-avibactam
n=515 Participants
Eligible participants who were hospitalized with gram negative infections and received at least one dose of ceftazidime-avibactam in routine clinical practice since 01-Jan-2018 were included in this chart review study.
Number of Participants Classified According to All Wards Attended During Hospitalization: FAS72+ Population
Surgical
101 Participants
Number of Participants Classified According to All Wards Attended During Hospitalization: FAS72+ Population
Medical
195 Participants
Number of Participants Classified According to All Wards Attended During Hospitalization: FAS72+ Population
Onco-hematology
58 Participants
Number of Participants Classified According to All Wards Attended During Hospitalization: FAS72+ Population
Infectious disease
27 Participants
Number of Participants Classified According to All Wards Attended During Hospitalization: FAS72+ Population
ICU
116 Participants
Number of Participants Classified According to All Wards Attended During Hospitalization: FAS72+ Population
Other
18 Participants

Adverse Events

Ceftazidime-avibactam

Serious events: 5 serious events
Other events: 2 other events
Deaths: 170 deaths

Serious adverse events

Serious adverse events
Measure
Ceftazidime-avibactam
n=569 participants at risk
Eligible participants who were hospitalized with gram negative infections and received at least one dose of ceftazidime-avibactam in routine clinical practice since 01-Jan-2018 were included in this chart review study.
General disorders
Multiple organ dysfunction syndrome
0.18%
1/569 • From index date up to 60 days after hospital discharge, in-hospital death, withdrawal from the study, or lost to follow-up, whichever occurred first (up to maximum of 464 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Only SAEs and non-SAEs with an explicit attribution to or associated with use of ceftazidime-avibactam from the data captured in medical records were collected in this study.
Hepatobiliary disorders
Cholestasis
0.18%
1/569 • From index date up to 60 days after hospital discharge, in-hospital death, withdrawal from the study, or lost to follow-up, whichever occurred first (up to maximum of 464 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Only SAEs and non-SAEs with an explicit attribution to or associated with use of ceftazidime-avibactam from the data captured in medical records were collected in this study.
Hepatobiliary disorders
Hepatocellular injury
0.18%
1/569 • From index date up to 60 days after hospital discharge, in-hospital death, withdrawal from the study, or lost to follow-up, whichever occurred first (up to maximum of 464 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Only SAEs and non-SAEs with an explicit attribution to or associated with use of ceftazidime-avibactam from the data captured in medical records were collected in this study.
Infections and infestations
Clostridium difficile colitis
0.18%
1/569 • From index date up to 60 days after hospital discharge, in-hospital death, withdrawal from the study, or lost to follow-up, whichever occurred first (up to maximum of 464 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Only SAEs and non-SAEs with an explicit attribution to or associated with use of ceftazidime-avibactam from the data captured in medical records were collected in this study.
Nervous system disorders
Altered state of consciousness
0.18%
1/569 • From index date up to 60 days after hospital discharge, in-hospital death, withdrawal from the study, or lost to follow-up, whichever occurred first (up to maximum of 464 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Only SAEs and non-SAEs with an explicit attribution to or associated with use of ceftazidime-avibactam from the data captured in medical records were collected in this study.
Nervous system disorders
Neurotoxicity
0.18%
1/569 • From index date up to 60 days after hospital discharge, in-hospital death, withdrawal from the study, or lost to follow-up, whichever occurred first (up to maximum of 464 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Only SAEs and non-SAEs with an explicit attribution to or associated with use of ceftazidime-avibactam from the data captured in medical records were collected in this study.
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
0.18%
1/569 • From index date up to 60 days after hospital discharge, in-hospital death, withdrawal from the study, or lost to follow-up, whichever occurred first (up to maximum of 464 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Only SAEs and non-SAEs with an explicit attribution to or associated with use of ceftazidime-avibactam from the data captured in medical records were collected in this study.

Other adverse events

Other adverse events
Measure
Ceftazidime-avibactam
n=569 participants at risk
Eligible participants who were hospitalized with gram negative infections and received at least one dose of ceftazidime-avibactam in routine clinical practice since 01-Jan-2018 were included in this chart review study.
Gastrointestinal disorders
Diarrhoea
0.18%
1/569 • From index date up to 60 days after hospital discharge, in-hospital death, withdrawal from the study, or lost to follow-up, whichever occurred first (up to maximum of 464 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Only SAEs and non-SAEs with an explicit attribution to or associated with use of ceftazidime-avibactam from the data captured in medical records were collected in this study.
Eye disorders
Blurred vision
0.18%
1/569 • From index date up to 60 days after hospital discharge, in-hospital death, withdrawal from the study, or lost to follow-up, whichever occurred first (up to maximum of 464 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Only SAEs and non-SAEs with an explicit attribution to or associated with use of ceftazidime-avibactam from the data captured in medical records were collected in this study.
Psychiatric disorders
Confusional state
0.18%
1/569 • From index date up to 60 days after hospital discharge, in-hospital death, withdrawal from the study, or lost to follow-up, whichever occurred first (up to maximum of 464 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Only SAEs and non-SAEs with an explicit attribution to or associated with use of ceftazidime-avibactam from the data captured in medical records were collected in this study.
Psychiatric disorders
Disorientation
0.18%
1/569 • From index date up to 60 days after hospital discharge, in-hospital death, withdrawal from the study, or lost to follow-up, whichever occurred first (up to maximum of 464 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Only SAEs and non-SAEs with an explicit attribution to or associated with use of ceftazidime-avibactam from the data captured in medical records were collected in this study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Results disclosure agreements

  • Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
  • Publication restrictions are in place

Restriction type: OTHER