Trial Outcomes & Findings for Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections) (NCT NCT01599806)
NCT ID: NCT01599806
Last Updated: 2017-09-06
Results Overview
Number of patients with symptomatic resolution (or return to premorbid state) of UTI-specific symptoms except flank pain (frequency/urgency/dysuria/suprapubic pain) with resolution of or improvement in flank pain based on the patient-reported symptom assessment response at the Day 5 visit in the mMITT analysis set. The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
641 participants
Primary outcome timeframe
At Day 5 visit. Day 5 visit is based on 24 hour periods from the first dose date and time.
Results posted on
2017-09-06
Participant Flow
The results presented in these forms represent the combined data base of the two identical protocols D4280C00002 and D4280C00004. The protocol D4280C00002 has a total of 522 randomized patients and the protocol D4280C00004 has a total of 511 randomized patients which adds up to a combined total of 1033 patients.
Participant milestones
| Measure |
CAZ-AVI
Ceftazidime-avibactam treatment group
|
Doripenem
Doripenem treatment group
|
|---|---|---|
|
Overall Study
STARTED
|
516
|
517
|
|
Overall Study
COMPLETED
|
473
|
476
|
|
Overall Study
NOT COMPLETED
|
43
|
41
|
Reasons for withdrawal
| Measure |
CAZ-AVI
Ceftazidime-avibactam treatment group
|
Doripenem
Doripenem treatment group
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
20
|
20
|
|
Overall Study
Withdrawal by Subject
|
12
|
12
|
|
Overall Study
Other Eligibility criteria
|
11
|
9
|
Baseline Characteristics
Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)
Baseline characteristics by cohort
| Measure |
CAZ-AVI
n=511 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=509 Participants
Doripenem treatment group
|
Total
n=1020 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.6 Years
STANDARD_DEVIATION 19.76 • n=5 Participants
|
52.3 Years
STANDARD_DEVIATION 18.83 • n=7 Participants
|
52.0 Years
STANDARD_DEVIATION 19.29 • n=5 Participants
|
|
Age, Customized
18-45
|
192 Participants
n=5 Participants
|
172 Participants
n=7 Participants
|
364 Participants
n=5 Participants
|
|
Age, Customized
46-64
|
162 Participants
n=5 Participants
|
177 Participants
n=7 Participants
|
339 Participants
n=5 Participants
|
|
Age, Customized
65-74
|
79 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
177 Participants
n=5 Participants
|
|
Age, Customized
75-90
|
78 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
349 Participants
n=5 Participants
|
357 Participants
n=7 Participants
|
706 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
162 Participants
n=5 Participants
|
152 Participants
n=7 Participants
|
314 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian Or Alaska Native
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
48 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black Or African American
|
1 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
40 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
421 Participants
n=5 Participants
|
426 Participants
n=7 Participants
|
847 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Day 5 visit. Day 5 visit is based on 24 hour periods from the first dose date and time.Population: Microbiological modified intent to treat analysis set (mMITT)
Number of patients with symptomatic resolution (or return to premorbid state) of UTI-specific symptoms except flank pain (frequency/urgency/dysuria/suprapubic pain) with resolution of or improvement in flank pain based on the patient-reported symptom assessment response at the Day 5 visit in the mMITT analysis set. The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)).
Outcome measures
| Measure |
CAZ-AVI
n=393 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=417 Participants
Doripenem treatment group
|
|---|---|---|
|
Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test
Symptomatic resolution
|
276 Participants
|
276 Participants
|
|
Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test
Symptom persistence
|
103 Participants
|
124 Participants
|
|
Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test
Indeterminate
|
14 Participants
|
17 Participants
|
PRIMARY outcome
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.Population: Microbiological modified intent to treat analysis set (mMITT)
Number of patients with both a favorable per patient microbiological response and symptomatic resolution (or return to premorbid state) of all UTI-specific symptoms (frequency/urgency/dysuria/suprapubic pain/flank pain) based on the patient-reported symptom assessment response at the TOC visit in the mMITT analysis set. The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)).
Outcome measures
| Measure |
CAZ-AVI
n=393 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=417 Participants
Doripenem treatment group
|
|---|---|---|
|
Combined Patient-reported Symptomatic and Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test
Favorable
|
280 Participants
|
269 Participants
|
|
Combined Patient-reported Symptomatic and Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test
Unfavorable
|
81 Participants
|
109 Participants
|
|
Combined Patient-reported Symptomatic and Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test
Indeterminate
|
32 Participants
|
39 Participants
|
PRIMARY outcome
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.Population: Microbiological modified intent to treat analysis set (mMITT)
Number of patients with a favorable per patient microbiological response at TOC. The primary efficacy outcome variable for ROW is the proportion of patients with a favorable per-patient microbiological response at the TOC visit in the mMITT analysis set.
Outcome measures
| Measure |
CAZ-AVI
n=393 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=417 Participants
Doripenem treatment group
|
|---|---|---|
|
Per-patient Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test
Favorable
|
304 Participants
|
296 Participants
|
|
Per-patient Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test
Unfavorable
|
58 Participants
|
83 Participants
|
|
Per-patient Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test
Indeterminate
|
31 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapyPopulation: Microbiological modified intent to treat analysis set (mMITT)
Number of patients with a favorable per-patient microbiological response at EOT (IV)
Outcome measures
| Measure |
CAZ-AVI
n=393 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=417 Participants
Doripenem treatment group
|
|---|---|---|
|
Per-patient Microbiological Response at EOT (IV) (mMITT Analysis Set)
Favorable
|
374 Participants
|
395 Participants
|
|
Per-patient Microbiological Response at EOT (IV) (mMITT Analysis Set)
Unfavorable
|
1 Participants
|
3 Participants
|
|
Per-patient Microbiological Response at EOT (IV) (mMITT Analysis Set)
Indeterminate
|
18 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.Population: Microbiological modified intent to treat analysis set (mMITT)
Number of patients with a favorable per patient microbiological response at LFU
Outcome measures
| Measure |
CAZ-AVI
n=393 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=417 Participants
Doripenem treatment group
|
|---|---|---|
|
Per-patient Microbiological Response at LFU (mMITT Analysis Set)
Favorable
|
268 Participants
|
254 Participants
|
|
Per-patient Microbiological Response at LFU (mMITT Analysis Set)
Unfavorable
|
83 Participants
|
125 Participants
|
|
Per-patient Microbiological Response at LFU (mMITT Analysis Set)
Indeterminate
|
42 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapyPopulation: Microbiological evaluable analysis set at EOT (IV) (ME at EOT (IV))
Number of patients with a favorable per-patient microbiological response at EOT (IV)
Outcome measures
| Measure |
CAZ-AVI
n=325 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=361 Participants
Doripenem treatment group
|
|---|---|---|
|
Per-patient Microbiological Response at EOT (IV) (ME at EOT (IV) Analysis Set)
Favorable
|
324 Participants
|
359 Participants
|
|
Per-patient Microbiological Response at EOT (IV) (ME at EOT (IV) Analysis Set)
Unfavorable
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.Population: Microbiological evaluable analysis set at TOC (ME at TOC)
Number of patients with a favorable per patient microbiological response at TOC
Outcome measures
| Measure |
CAZ-AVI
n=286 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=298 Participants
Doripenem treatment group
|
|---|---|---|
|
Per-patient Microbiological Response at TOC (ME at TOC Analysis Set)
Unfavorable
|
45 Participants
|
73 Participants
|
|
Per-patient Microbiological Response at TOC (ME at TOC Analysis Set)
Favorable
|
241 Participants
|
225 Participants
|
SECONDARY outcome
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.Population: Microbiological evaluable analysis set at LFU (ME at LFU)
Number of patients with a favorable per patient microbiological response at LFU
Outcome measures
| Measure |
CAZ-AVI
n=245 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=262 Participants
Doripenem treatment group
|
|---|---|---|
|
Per-patient Microbiological Response at LFU (ME at LFU Analysis Set)
Favorable
|
182 Participants
|
166 Participants
|
|
Per-patient Microbiological Response at LFU (ME at LFU Analysis Set)
Unfavorable
|
63 Participants
|
96 Participants
|
SECONDARY outcome
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapyPopulation: Extended microbiological evaluable analysis set at EOT (IV) (EME at EOT (IV))
Number of patients with a favorable per-patient microbiological response at EOT (IV)
Outcome measures
| Measure |
CAZ-AVI
n=336 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=371 Participants
Doripenem treatment group
|
|---|---|---|
|
Per-patient Microbiological Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set)
Favorable
|
335 Participants
|
369 Participants
|
|
Per-patient Microbiological Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set)
Unfavorable
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.Population: Extended microbiological evaluable analysis set at TOC (Extended ME at TOC)
Number of patients with a favorable per patient microbiological response at TOC
Outcome measures
| Measure |
CAZ-AVI
n=292 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=311 Participants
Doripenem treatment group
|
|---|---|---|
|
Per-patient Microbiological Response at TOC (Extended ME at TOC Analysis Set)
Favorable
|
243 Participants
|
236 Participants
|
|
Per-patient Microbiological Response at TOC (Extended ME at TOC Analysis Set)
Unfavorable
|
49 Participants
|
75 Participants
|
SECONDARY outcome
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.Population: Extended microbiological evaluable analysis set at LFU (Extended ME at LFU)
Number of patients with a favorable per patient microbiological response at LFU
Outcome measures
| Measure |
CAZ-AVI
n=251 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=272 Participants
Doripenem treatment group
|
|---|---|---|
|
Per-patient Microbiological Response at LFU (Extended ME at LFU Analysis Set)
Favorable
|
184 Participants
|
173 Participants
|
|
Per-patient Microbiological Response at LFU (Extended ME at LFU Analysis Set)
Unfavorable
|
67 Participants
|
99 Participants
|
SECONDARY outcome
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapyPopulation: Microbiological modified intent to treat analysis set (mMITT)
Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
Outcome measures
| Measure |
CAZ-AVI
n=393 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=417 Participants
Doripenem treatment group
|
|---|---|---|
|
Investigator Determined Clinical Response at EOT (IV) (mMITT Analysis Set)
Clinical cure
|
378 Participants
|
407 Participants
|
|
Investigator Determined Clinical Response at EOT (IV) (mMITT Analysis Set)
Clinical failure
|
5 Participants
|
5 Participants
|
|
Investigator Determined Clinical Response at EOT (IV) (mMITT Analysis Set)
Indeterminate
|
10 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.Population: Microbiological modified intent to treat analysis set (mMITT)
Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
Outcome measures
| Measure |
CAZ-AVI
n=393 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=417 Participants
Doripenem treatment group
|
|---|---|---|
|
Investigator Determined Clinical Response at TOC (mMITT Analysis Set)
Clinical cure
|
355 Participants
|
377 Participants
|
|
Investigator Determined Clinical Response at TOC (mMITT Analysis Set)
Clinical failure
|
11 Participants
|
24 Participants
|
|
Investigator Determined Clinical Response at TOC (mMITT Analysis Set)
Indeterminate
|
27 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.Population: Microbiological modified intent to treat analysis set (mMITT)
Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
Outcome measures
| Measure |
CAZ-AVI
n=393 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=417 Participants
Doripenem treatment group
|
|---|---|---|
|
Investigator Determined Clinical Response at LFU (mMITT Analysis Set)
Clinical cure
|
335 Participants
|
350 Participants
|
|
Investigator Determined Clinical Response at LFU (mMITT Analysis Set)
Clinical failure
|
23 Participants
|
39 Participants
|
|
Investigator Determined Clinical Response at LFU (mMITT Analysis Set)
Indeterminate
|
35 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapyPopulation: Microbiological evaluable analysis set at EOT (IV) (ME at EOT (IV))
Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
Outcome measures
| Measure |
CAZ-AVI
n=325 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=361 Participants
Doripenem treatment group
|
|---|---|---|
|
Investigator Determined Clinical Response at EOT (IV) (ME at EOT (IV) Analysis Set)
Clinical cure
|
318 Participants
|
358 Participants
|
|
Investigator Determined Clinical Response at EOT (IV) (ME at EOT (IV) Analysis Set)
Clinical failure
|
4 Participants
|
2 Participants
|
|
Investigator Determined Clinical Response at EOT (IV) (ME at EOT (IV) Analysis Set)
Indeterminate
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.Population: Microbiological evaluable analysis set at TOC (ME at TOC )
Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
Outcome measures
| Measure |
CAZ-AVI
n=286 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=298 Participants
Doripenem treatment group
|
|---|---|---|
|
Investigator Determined Clinical Response at TOC (ME at TOC Analysis Set)
Clinical cure
|
277 Participants
|
285 Participants
|
|
Investigator Determined Clinical Response at TOC (ME at TOC Analysis Set)
Clinical failure
|
4 Participants
|
13 Participants
|
|
Investigator Determined Clinical Response at TOC (ME at TOC Analysis Set)
Indeterminate
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.Population: Microbiological evaluable analysis set at LFU (ME at LFU)
Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
Outcome measures
| Measure |
CAZ-AVI
n=245 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=262 Participants
Doripenem treatment group
|
|---|---|---|
|
Investigator Determined Clinical Response at LFU (ME at LFU Analysis Set)
Clinical cure
|
226 Participants
|
236 Participants
|
|
Investigator Determined Clinical Response at LFU (ME at LFU Analysis Set)
Clinical failure
|
15 Participants
|
24 Participants
|
|
Investigator Determined Clinical Response at LFU (ME at LFU Analysis Set)
Indeterminate
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapyPopulation: Extended microbiological evaluable analysis set at EOT (IV) (Extended ME at EOT (IV))
Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
Outcome measures
| Measure |
CAZ-AVI
n=336 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=371 Participants
Doripenem treatment group
|
|---|---|---|
|
Investigator Determined Clinical Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set)
Clinical cure
|
327 Participants
|
368 Participants
|
|
Investigator Determined Clinical Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set)
Clinical failure
|
4 Participants
|
2 Participants
|
|
Investigator Determined Clinical Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set)
Indeterminate
|
5 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.Population: Extended microbiological evaluable analysis set at TOC (Extended ME at TOC)
Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
Outcome measures
| Measure |
CAZ-AVI
n=292 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=311 Participants
Doripenem treatment group
|
|---|---|---|
|
Investigator Determined Clinical Response at TOC (Extended ME at TOC Analysis Set)
Clinical cure
|
283 Participants
|
298 Participants
|
|
Investigator Determined Clinical Response at TOC (Extended ME at TOC Analysis Set)
Clinical failure
|
4 Participants
|
13 Participants
|
|
Investigator Determined Clinical Response at TOC (Extended ME at TOC Analysis Set)
Indeterminate
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.Population: Extended microbiological evaluable analysis set at LFU (Extended ME at LFU)
Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
Outcome measures
| Measure |
CAZ-AVI
n=251 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=272 Participants
Doripenem treatment group
|
|---|---|---|
|
Investigator Determined Clinical Response at LFU (Extended ME at LFU Analysis Set)
Clinical cure
|
232 Participants
|
246 Participants
|
|
Investigator Determined Clinical Response at LFU (Extended ME at LFU Analysis Set)
Clinical failure
|
15 Participants
|
24 Participants
|
|
Investigator Determined Clinical Response at LFU (Extended ME at LFU Analysis Set)
Indeterminate
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapyPopulation: Clinically evaluable analysis set at EOT (IV) (CE at EOT (IV))
Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
Outcome measures
| Measure |
CAZ-AVI
n=350 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=391 Participants
Doripenem treatment group
|
|---|---|---|
|
Investigator Determined Clinical Response at EOT (IV) (CE at EOT (IV) Analysis Set)
Clinical cure
|
346 Participants
|
387 Participants
|
|
Investigator Determined Clinical Response at EOT (IV) (CE at EOT (IV) Analysis Set)
Clinical failure
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.Population: Clinically evaluable analysis set at TOC (CE at TOC)
Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
Outcome measures
| Measure |
CAZ-AVI
n=297 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=330 Participants
Doripenem treatment group
|
|---|---|---|
|
Investigator Determined Clinical Response at TOC (CE at TOC Analysis Set)
Clinical cure
|
289 Participants
|
309 Participants
|
|
Investigator Determined Clinical Response at TOC (CE at TOC Analysis Set)
Clinical failure
|
8 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.Population: Clinically evaluable analysis set at LFU (CE at LFU)
Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
Outcome measures
| Measure |
CAZ-AVI
n=254 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=287 Participants
Doripenem treatment group
|
|---|---|---|
|
Investigator Determined Clinical Response at LFU (CE at LFU Analysis Set)
Clinical cure
|
235 Participants
|
254 Participants
|
|
Investigator Determined Clinical Response at LFU (CE at LFU Analysis Set)
Clinical failure
|
19 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.Population: Microbiological modified intent to treat analysis set (mMITT)
Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the mMITT analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen.
Outcome measures
| Measure |
CAZ-AVI
n=393 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=417 Participants
Doripenem treatment group
|
|---|---|---|
|
Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)
All patients - Clinical cure (n=75, 84)
|
67 Participants
|
75 Participants
|
|
Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)
Escherichia coli patients - Clin cure (n=36, 37)
|
33 Participants
|
31 Participants
|
|
Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)
Klebsiella pneumoniae patients-Clin cure(n=18,30)
|
17 Participants
|
28 Participants
|
|
Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)
Pseudomonas aeruginosa patients- Clin cure(n=7,6)
|
5 Participants
|
6 Participants
|
|
Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)
Enterobacter cloacae patients-Clin cure(n=7,6)
|
5 Participants
|
5 Participants
|
|
Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)
Proteus mirabilis patients - Clin cure (n=2, 5)
|
2 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.Population: Microbiological evaluable analysis set at TOC(ME at TOC)
Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the ME at TOC analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen.
Outcome measures
| Measure |
CAZ-AVI
n=286 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=298 Participants
Doripenem treatment group
|
|---|---|---|
|
Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)
All patients - Clinical cure (n=48, 57)
|
47 Participants
|
55 Participants
|
|
Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)
Escherichia coli patients-Clin cure (n=23,27)
|
22 Participants
|
25 Participants
|
|
Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)
Klebsiella pneumoniae patients-Clin cure(n=14, 22)
|
14 Participants
|
22 Participants
|
|
Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)
Pseudomonas aeruginosa patients-Clin cure(n=1, 2)
|
1 Participants
|
2 Participants
|
|
Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)
Enterobacter cloacae patients-Clin cure(n=5,5)
|
5 Participants
|
5 Participants
|
|
Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)
Proteus mirabilis patients - Clin cure (n=0, 2)
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.Population: Extended microbiological evaluable analysis set at TOC(Extended ME at TOC)
Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the Extended ME at TOC analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen.
Outcome measures
| Measure |
CAZ-AVI
n=292 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=311 Participants
Doripenem treatment group
|
|---|---|---|
|
Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)
All patients - Clinical cure (n=51, 63)
|
50 Participants
|
61 Participants
|
|
Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)
Escherichia coli patients - Clin cure (n=23, 27)
|
22 Participants
|
25 Participants
|
|
Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)
Klebsiella pneumoniae patients-Clin cure(n=15, 23)
|
15 Participants
|
23 Participants
|
|
Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)
Pseudomonas aeruginosa patients-Clin cure(n=3,6)
|
3 Participants
|
6 Participants
|
|
Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)
Enterobacter cloacae patients-Clin cure(n=5,5)
|
5 Participants
|
5 Participants
|
|
Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)
Proteus mirabilis patients - Clin cure (n=0, 2)
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.Population: Microbiological modified intent to treat analysis set (mMITT)
Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the mMITT analysis set.
Outcome measures
| Measure |
CAZ-AVI
n=75 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=84 Participants
Doripenem treatment group
|
|---|---|---|
|
Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)
Favorable
|
47 Participants
|
51 Participants
|
|
Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)
Unfavorable
|
19 Participants
|
27 Participants
|
|
Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)
Indeterminate
|
9 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.Population: Microbiological evaluable analysis set at TOC(ME at TOC)
Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the ME at TOC analysis set.
Outcome measures
| Measure |
CAZ-AVI
n=48 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=57 Participants
Doripenem treatment group
|
|---|---|---|
|
Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)
Favorable
|
35 Participants
|
37 Participants
|
|
Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)
Unfavorable
|
13 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.Population: Extended microbiological evaluable analysis set at TOC(Extended ME at TOC)
Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the Extended ME at TOC analysis set.
Outcome measures
| Measure |
CAZ-AVI
n=51 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=63 Participants
Doripenem treatment group
|
|---|---|---|
|
Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)
Favorable
|
37 Participants
|
41 Participants
|
|
Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)
Unfavorable
|
14 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.Population: Microbiological modified intent to treat analysis set (mMITT)
Time to first defervescence while on IV study therapy in patients in the mMITT analysis set who have fever at study entry.
Outcome measures
| Measure |
CAZ-AVI
n=393 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=417 Participants
Doripenem treatment group
|
|---|---|---|
|
Time to First Defervescence While on IV Study Therapy (mMITT Analysis Set)
Number of patients with fever (>38°C) at baseline
|
157 Participants
|
150 Participants
|
|
Time to First Defervescence While on IV Study Therapy (mMITT Analysis Set)
Number afebrile at the time of the last obs
|
155 Participants
|
143 Participants
|
|
Time to First Defervescence While on IV Study Therapy (mMITT Analysis Set)
Number censored at the time of the last obs
|
2 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.Population: Microbiological evaluable analysis set at TOC(ME at TOC)
Time to first defervescence while on IV study therapy in patients in the ME at TOC analysis set who have fever at study entry.
Outcome measures
| Measure |
CAZ-AVI
n=286 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=298 Participants
Doripenem treatment group
|
|---|---|---|
|
Time to First Defervescence While on IV Study Therapy (ME at TOC Analysis Set)
Number of patients with fever (>38°C) at baseline
|
124 Participants
|
108 Participants
|
|
Time to First Defervescence While on IV Study Therapy (ME at TOC Analysis Set)
Number afebrile at the time of the last obs
|
124 Participants
|
105 Participants
|
|
Time to First Defervescence While on IV Study Therapy (ME at TOC Analysis Set)
Number censored at the time of the last obs
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.Population: Extended microbiological evaluable analysis set at TOC(Extended ME at TOC)
Time to first defervescence while on IV study therapy in patients in the Extended ME at TOC analysis set who have fever at study entry.
Outcome measures
| Measure |
CAZ-AVI
n=292 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=311 Participants
Doripenem treatment group
|
|---|---|---|
|
Time to First Defervescence While on IV Study Therapy (Extended ME at TOC Analysis Set)
Number of patients with fever (>38°C) at baseline
|
124 Participants
|
111 Participants
|
|
Time to First Defervescence While on IV Study Therapy (Extended ME at TOC Analysis Set)
Number afebrile at the time of the last obs
|
124 Participants
|
108 Participants
|
|
Time to First Defervescence While on IV Study Therapy (Extended ME at TOC Analysis Set)
Number censored at the time of the last obs
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.Population: Clinically evaluable analysis set at TOC(CE at TOC)
Time to first defervescence while on IV study therapy in patients in the CE at TOC analysis set who have fever at study entry.
Outcome measures
| Measure |
CAZ-AVI
n=297 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=330 Participants
Doripenem treatment group
|
|---|---|---|
|
Time to First Defervescence While on IV Study Therapy (CE at TOC Analysis Set)
Number of patients with fever (>38°C) at baseline
|
123 Participants
|
118 Participants
|
|
Time to First Defervescence While on IV Study Therapy (CE at TOC Analysis Set)
Number afebrile at the time of the last obs
|
122 Participants
|
113 Participants
|
|
Time to First Defervescence While on IV Study Therapy (CE at TOC Analysis Set)
Number censored at the time of the last obs
|
1 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapyPopulation: Microbiological modified intent to treat analysis set (mMITT)
Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the mMITT analysis set
Outcome measures
| Measure |
CAZ-AVI
n=393 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=417 Participants
Doripenem treatment group
|
|---|---|---|
|
Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (mMITT Analysis Set)
Escherichia coli - Favorable (n=292, 306)
|
280 Participant
|
293 Participant
|
|
Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (mMITT Analysis Set)
Klebsiella pneumoniae - Favorable (n=44, 56)
|
41 Participant
|
51 Participant
|
|
Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (mMITT Analysis Set)
Proteus mirabilis - Favorable (n=17, 13)
|
16 Participant
|
11 Participant
|
|
Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (mMITT Analysis Set)
Enterobacter cloacae - Favorable (n= 11,13)
|
9 Participant
|
13 Participant
|
|
Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (mMITT Analysis Set)
Pseudomonas aeruginosa - Favorable (n=18, 20)
|
17 Participant
|
18 Participant
|
SECONDARY outcome
Timeframe: At TOC visit. TOC visit is 21 to 25 days from RandomizationPopulation: Microbiological modified intent to treat analysis set (mMITT)
Number of favorable per-pathogen microbiological responses at the TOC visit in the mMITT analysis set
Outcome measures
| Measure |
CAZ-AVI
n=393 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=417 Participants
Doripenem treatment group
|
|---|---|---|
|
Per-pathogen Microbiological Response at TOC for Baseline Pathogen (mMITT Analysis Set)
Escherichia coli - Favorable (n=292, 306)
|
229 Participant
|
220 Participant
|
|
Per-pathogen Microbiological Response at TOC for Baseline Pathogen (mMITT Analysis Set)
Klebsiella pneumoniae - Favorable (n=44, 56)
|
33 Participant
|
35 Participant
|
|
Per-pathogen Microbiological Response at TOC for Baseline Pathogen (mMITT Analysis Set)
Proteus mirabilis - Favorable (n=17, 13)
|
16 Participant
|
9 Participant
|
|
Per-pathogen Microbiological Response at TOC for Baseline Pathogen (mMITT Analysis Set)
Enterobacter cloacae - Favorable (n= 11,13)
|
6 Participant
|
9 Participant
|
|
Per-pathogen Microbiological Response at TOC for Baseline Pathogen (mMITT Analysis Set)
Pseudomonas aeruginosa - Favorable (n=18, 20)
|
12 Participant
|
15 Participant
|
SECONDARY outcome
Timeframe: At LFU visit. LFU visit is 45 to 52 days from RandomizationPopulation: Microbiological modified intent to treat analysis set (mMITT)
Number of favorable per-pathogen microbiological responses at the LFU visit in the mMITT analysis set
Outcome measures
| Measure |
CAZ-AVI
n=393 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=417 Participants
Doripenem treatment group
|
|---|---|---|
|
Per-pathogen Microbiological Response at LFU for Baseline Pathogen (mMITT Analysis Set)
Escherichia coli - Favorable (n=292, 306)
|
198 Participant
|
189 Participant
|
|
Per-pathogen Microbiological Response at LFU for Baseline Pathogen (mMITT Analysis Set)
Klebsiella pneumoniae - Favorable (n=44, 56)
|
32 Participant
|
30 Participant
|
|
Per-pathogen Microbiological Response at LFU for Baseline Pathogen (mMITT Analysis Set)
Proteus mirabilis - Favorable (n=17, 13)
|
16 Participant
|
6 Participant
|
|
Per-pathogen Microbiological Response at LFU for Baseline Pathogen (mMITT Analysis Set)
Enterobacter cloacae - Favorable (n= 11,13)
|
6 Participant
|
9 Participant
|
|
Per-pathogen Microbiological Response at LFU for Baseline Pathogen (mMITT Analysis Set)
Pseudomonas aeruginosa - Favorable (n=18, 20)
|
9 Participant
|
13 Participant
|
SECONDARY outcome
Timeframe: At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapyPopulation: Extended microbiological evaluable analysis set at EOT (IV) (EME at EOT (IV))
Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the Extended ME at EOT (IV) analysis set
Outcome measures
| Measure |
CAZ-AVI
n=336 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=371 Participants
Doripenem treatment group
|
|---|---|---|
|
Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (Extended ME at EOT (IV) Analysis Set)
Escherichia coli - Favorable (n=250, 274)
|
250 Participant
|
274 Participant
|
|
Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (Extended ME at EOT (IV) Analysis Set)
Klebsiella pneumoniae - Favorable (n=34, 49)
|
34 Participant
|
48 Participant
|
|
Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (Extended ME at EOT (IV) Analysis Set)
Proteus mirabilis - Favorable (n=13, 11)
|
13 Participant
|
11 Participant
|
|
Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (Extended ME at EOT (IV) Analysis Set)
Enterobacter cloacae - Favorable (n= 9, 12)
|
9 Participant
|
12 Participant
|
|
Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (Extended ME at EOT (IV) Analysis Set)
Pseudomonas aeruginosa - Favorable (n=18, 18)
|
17 Participant
|
17 Participant
|
SECONDARY outcome
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.Population: Extended microbiological evaluable analysis set at TOC (EME at TOC)
Number of favorable per-pathogen microbiological responses at the TOC visit in the Extended ME at TOC analysis set
Outcome measures
| Measure |
CAZ-AVI
n=292 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=311 Participants
Doripenem treatment group
|
|---|---|---|
|
Per-pathogen Microbiological Response at TOC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Escherichia coli - Favorable (n=214, 226)
|
180 Participant
|
176 Participant
|
|
Per-pathogen Microbiological Response at TOC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Klebsiella pneumoniae - Favorable (n=32, 42)
|
26 Participant
|
29 Participant
|
|
Per-pathogen Microbiological Response at TOC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Proteus mirabilis - Favorable (n=14, 7)
|
14 Participant
|
4 Participant
|
|
Per-pathogen Microbiological Response at TOC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Enterobacter cloacae - Favorable (n= 7, 11)
|
5 Participant
|
8 Participant
|
|
Per-pathogen Microbiological Response at TOC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Pseudomonas aeruginosa - Favorable (n=13, 18)
|
8 Participant
|
13 Participant
|
SECONDARY outcome
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.Population: Extended microbiological evaluable analysis set at LFU (EME at LFU)
Number of favorable per-pathogen microbiological responses at the LFU visit in the Extended ME at LFU analysis set
Outcome measures
| Measure |
CAZ-AVI
n=251 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=272 Participants
Doripenem treatment group
|
|---|---|---|
|
Per-pathogen Microbiological Response at LFU for Baseline Pathogen (Extended ME at LFU Analysis Set)
Escherichia coli - Favorable (n=179, 198)
|
129 Participant
|
131 Participant
|
|
Per-pathogen Microbiological Response at LFU for Baseline Pathogen (Extended ME at LFU Analysis Set)
Klebsiella pneumoniae - Favorable (n=31, 36)
|
24 Participant
|
19 Participant
|
|
Per-pathogen Microbiological Response at LFU for Baseline Pathogen (Extended ME at LFU Analysis Set)
Proteus mirabilis - Favorable (n=11,5)
|
11 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at LFU for Baseline Pathogen (Extended ME at LFU Analysis Set)
Enterobacter cloacae - Favorable (n= 7, 11)
|
5 Participant
|
8 Participant
|
|
Per-pathogen Microbiological Response at LFU for Baseline Pathogen (Extended ME at LFU Analysis Set)
Pseudomonas aeruginosa - Favorable (n=12, 16)
|
7 Participant
|
9 Participant
|
SECONDARY outcome
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapyPopulation: Microbiological evaluable analysis set at EOT (IV) (ME at EOT (IV))
Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the ME at EOT (IV) analysis set
Outcome measures
| Measure |
CAZ-AVI
n=325 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=361 Participants
Doripenem treatment group
|
|---|---|---|
|
Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (ME at EOT (IV) Analysis Set)
Escherichia coli - Favorable (n=249, 270)
|
249 Participant
|
270 Participant
|
|
Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (ME at EOT (IV) Analysis Set)
Klebsiella pneumoniae - Favorable (n=33, 48)
|
33 Participant
|
47 Participant
|
|
Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (ME at EOT (IV) Analysis Set)
Proteus mirabilis - Favorable (n=13,11)
|
13 Participant
|
11 Participant
|
|
Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (ME at EOT (IV) Analysis Set)
Enterobacter cloacae - Favorable (n= 9, 12)
|
9 Participant
|
12 Participant
|
|
Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (ME at EOT (IV) Analysis Set)
Pseudomonas aeruginosa - Favorable (n=10, 15)
|
9 Participant
|
14 Participant
|
SECONDARY outcome
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.Population: Microbiological evaluable analysis set at TOC (ME at TOC)
Number of favorable per-pathogen microbiological responses at the TOC visit in the ME at TOC analysis set
Outcome measures
| Measure |
CAZ-AVI
n=286 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=298 Participants
Doripenem treatment group
|
|---|---|---|
|
Per-pathogen Microbiological Response at TOC for Baseline Pathogen (ME at TOC Analysis Set)
Escherichia coli - Favorable (n=214, 221)
|
180 Participant
|
171 Participant
|
|
Per-pathogen Microbiological Response at TOC for Baseline Pathogen (ME at TOC Analysis Set)
Klebsiella pneumoniae - Favorable (n=31, 41)
|
25 Participant
|
28 Participant
|
|
Per-pathogen Microbiological Response at TOC for Baseline Pathogen (ME at TOC Analysis Set)
Proteus mirabilis - Favorable (n=14, 7)
|
14 Participant
|
4 Participant
|
|
Per-pathogen Microbiological Response at TOC for Baseline Pathogen (ME at TOC Analysis Set)
Enterobacter cloacae - Favorable (n= 7, 11)
|
5 Participant
|
8 Participant
|
|
Per-pathogen Microbiological Response at TOC for Baseline Pathogen (ME at TOC Analysis Set)
Pseudomonas aeruginosa - Favorable (n=9, 13)
|
7 Participant
|
9 Participant
|
SECONDARY outcome
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.Population: Microbiological evaluable analysis set at LFU (ME at LFU)
Number of favorable per-pathogen microbiological responses at the LFU visit in the ME at LFU analysis set
Outcome measures
| Measure |
CAZ-AVI
n=245 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=262 Participants
Doripenem treatment group
|
|---|---|---|
|
Per-pathogen Microbiological Response at LFU for Baseline Pathogen (ME at LFU Analysis Set)
Escherichia coli - Favorable (n=179, 194)
|
129 Participant
|
127 Participant
|
|
Per-pathogen Microbiological Response at LFU for Baseline Pathogen (ME at LFU Analysis Set)
Klebsiella pneumoniae - Favorable (n=30, 35)
|
23 Participant
|
18 Participant
|
|
Per-pathogen Microbiological Response at LFU for Baseline Pathogen (ME at LFU Analysis Set)
Proteus mirabilis - Favorable (n=11,5)
|
11 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at LFU for Baseline Pathogen (ME at LFU Analysis Set)
Enterobacter cloacae - Favorable (n= 7, 11)
|
5 Participant
|
8 Participant
|
|
Per-pathogen Microbiological Response at LFU for Baseline Pathogen (ME at LFU Analysis Set)
Pseudomonas aeruginosa - Favorable (n=8, 13)
|
6 Participant
|
8 Participant
|
SECONDARY outcome
Timeframe: At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapyPopulation: Microbiological modified intent to treat analysis set (mMITT)
Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the mMITT analysis set for blood only
Outcome measures
| Measure |
CAZ-AVI
n=393 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=417 Participants
Doripenem treatment group
|
|---|---|---|
|
Per-pathogen Microbiological Response at EOT (IV) for Blood Only (mMITT Analysis Set)
Escherichia coli - Favorable (n=32, 28)
|
31 Participant
|
28 Participant
|
|
Per-pathogen Microbiological Response at EOT (IV) for Blood Only (mMITT Analysis Set)
Klebsiella pneumoniae - Favorable (n=4, 2)
|
2 Participant
|
2 Participant
|
|
Per-pathogen Microbiological Response at EOT (IV) for Blood Only (mMITT Analysis Set)
Proteus mirabilis - Favorable (n=1, 0)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at EOT (IV) for Blood Only (mMITT Analysis Set)
Pseudomonas aeruginosa - Favorable (n=1, 2)
|
1 Participant
|
2 Participant
|
SECONDARY outcome
Timeframe: At TOC visit. TOC visit is 21 to 25 days from RandomizationPopulation: Microbiological modified intent to treat analysis set (mMITT)
Number of favorable per-pathogen microbiological responses at the TOC visit in the mMITT analysis set for blood only
Outcome measures
| Measure |
CAZ-AVI
n=393 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=417 Participants
Doripenem treatment group
|
|---|---|---|
|
Per-pathogen Microbiological Response at TOC for Blood Only (mMITT Analysis Set)
Escherichia coli - Favorable (n=32, 28)
|
31 Participant
|
28 Participant
|
|
Per-pathogen Microbiological Response at TOC for Blood Only (mMITT Analysis Set)
Klebsiella pneumoniae - Favorable (n=4, 2)
|
3 Participant
|
2 Participant
|
|
Per-pathogen Microbiological Response at TOC for Blood Only (mMITT Analysis Set)
Proteus mirabilis - Favorable (n=1, 0)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC for Blood Only (mMITT Analysis Set)
Pseudomonas aeruginosa - Favorable (n=1, 2)
|
1 Participant
|
2 Participant
|
SECONDARY outcome
Timeframe: At LFU visit. LFU visit is 45 to 52 days from RandomizationPopulation: Microbiological modified intent to treat analysis set (mMITT)
Number of favorable per-pathogen microbiological responses at the LFU visit in the mMITT analysis set for blood only
Outcome measures
| Measure |
CAZ-AVI
n=393 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=417 Participants
Doripenem treatment group
|
|---|---|---|
|
Per-pathogen Microbiological Response at LFU for Blood Only (mMITT Analysis Set)
Escherichia coli - Favorable (n=32, 28)
|
29 Participant
|
27 Participant
|
|
Per-pathogen Microbiological Response at LFU for Blood Only (mMITT Analysis Set)
Klebsiella pneumoniae - Favorable (n=4, 2)
|
3 Participant
|
2 Participant
|
|
Per-pathogen Microbiological Response at LFU for Blood Only (mMITT Analysis Set)
Proteus mirabilis - Favorable (n=1, 0)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at LFU for Blood Only (mMITT Analysis Set)
Pseudomonas aeruginosa - Favorable (n=1, 2)
|
1 Participant
|
2 Participant
|
SECONDARY outcome
Timeframe: At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapyPopulation: Extended microbiological evaluable analysis set at EOT (IV) (EME at EOT (IV))
Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the Extended ME at EOT (IV) analysis set for blood only
Outcome measures
| Measure |
CAZ-AVI
n=336 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=371 Participants
Doripenem treatment group
|
|---|---|---|
|
Per-pathogen Microbiological Response at EOT (IV) for Blood Only (Extended ME at EOT (IV) Analysis Set)
Escherichia coli - Favorable (n=26, 24)
|
26 Participant
|
24 Participant
|
|
Per-pathogen Microbiological Response at EOT (IV) for Blood Only (Extended ME at EOT (IV) Analysis Set)
Klebsiella pneumoniae - Favorable (n=2, 1)
|
1 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at EOT (IV) for Blood Only (Extended ME at EOT (IV) Analysis Set)
Proteus mirabilis - Favorable (n=1, 0)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at EOT (IV) for Blood Only (Extended ME at EOT (IV) Analysis Set)
Pseudomonas aeruginosa - Favorable (n=1, 2)
|
1 Participant
|
2 Participant
|
SECONDARY outcome
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.Population: Extended microbiological evaluable analysis set at TOC (EME at TOC)
Number of favorable per-pathogen microbiological responses at the TOC visit in the Extended ME at TOC analysis set for blood only
Outcome measures
| Measure |
CAZ-AVI
n=292 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=311 Participants
Doripenem treatment group
|
|---|---|---|
|
Per-pathogen Microbiological Response at TOC for Blood Only (Extended ME at TOC Analysis Set)
Escherichia coli - Favorable (n=22, 20)
|
22 Participant
|
20 Participant
|
|
Per-pathogen Microbiological Response at TOC for Blood Only (Extended ME at TOC Analysis Set)
Klebsiella pneumoniae - Favorable (n=2, 2)
|
2 Participant
|
2 Participant
|
|
Per-pathogen Microbiological Response at TOC for Blood Only (Extended ME at TOC Analysis Set)
Proteus mirabilis - Favorable (n=1, 0)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC for Blood Only (Extended ME at TOC Analysis Set)
Pseudomonas aeruginosa - Favorable (n=0, 1)
|
0 Participant
|
1 Participant
|
SECONDARY outcome
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.Population: Extended microbiological evaluable analysis set at LFU (EME at LFU)
Number of favorable per-pathogen microbiological responses at the LFU visit in the Extended ME at LFU analysis set for blood only
Outcome measures
| Measure |
CAZ-AVI
n=251 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=272 Participants
Doripenem treatment group
|
|---|---|---|
|
Per-pathogen Microbiological Response at LFU for Blood Only (Extended ME at LFU Analysis Set)
Escherichia coli - Favorable (n=19, 18)
|
19 Participant
|
17 Participant
|
|
Per-pathogen Microbiological Response at LFU for Blood Only (Extended ME at LFU Analysis Set)
Klebsiella pneumoniae - Favorable (n=2, 1)
|
2 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at LFU for Blood Only (Extended ME at LFU Analysis Set)
Proteus mirabilis - Favorable (n=1, 0)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at LFU for Blood Only (Extended ME at LFU Analysis Set)
Pseudomonas aeruginosa - Favorable (n=0, 1)
|
0 Participant
|
1 Participant
|
SECONDARY outcome
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapyPopulation: Microbiological evaluable analysis set at EOT (IV) (ME at EOT (IV))
Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the ME at EOT (IV) analysis set for blood only
Outcome measures
| Measure |
CAZ-AVI
n=325 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=361 Participants
Doripenem treatment group
|
|---|---|---|
|
Per-pathogen Microbiological Response at EOT (IV) for Blood Only (ME at EOT (IV) Analysis Set)
Escherichia coli - Favorable (n=26, 24)
|
26 Participant
|
24 Participant
|
|
Per-pathogen Microbiological Response at EOT (IV) for Blood Only (ME at EOT (IV) Analysis Set)
Klebsiella pneumoniae - Favorable (n=2, 1)
|
1 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at EOT (IV) for Blood Only (ME at EOT (IV) Analysis Set)
Proteus mirabilis - Favorable (n=1, 0)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at EOT (IV) for Blood Only (ME at EOT (IV) Analysis Set)
Pseudomonas aeruginosa - Favorable (n=1, 2)
|
1 Participant
|
2 Participant
|
SECONDARY outcome
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.Population: Microbiological evaluable analysis set at TOC (ME at TOC)
Number of favorable per-pathogen microbiological responses at the TOC visit in the ME at TOC analysis set for blood only
Outcome measures
| Measure |
CAZ-AVI
n=286 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=298 Participants
Doripenem treatment group
|
|---|---|---|
|
Per-pathogen Microbiological Response at TOC for Blood Only (ME at TOC Analysis Set)
Escherichia coli - Favorable (n=22, 20)
|
22 Participant
|
20 Participant
|
|
Per-pathogen Microbiological Response at TOC for Blood Only (ME at TOC Analysis Set)
Klebsiella pneumoniae - Favorable (n=2, 2)
|
2 Participant
|
2 Participant
|
|
Per-pathogen Microbiological Response at TOC for Blood Only (ME at TOC Analysis Set)
Proteus mirabilis - Favorable (n=1, 0)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC for Blood Only (ME at TOC Analysis Set)
Pseudomonas aeruginosa - Favorable (n=0, 1)
|
0 Participant
|
1 Participant
|
SECONDARY outcome
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.Population: Microbiological evaluable analysis set at LFU (ME at LFU)
Number of favorable per-pathogen microbiological responses at the LFU visit in the ME at LFU analysis set for blood only
Outcome measures
| Measure |
CAZ-AVI
n=245 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=262 Participants
Doripenem treatment group
|
|---|---|---|
|
Per-pathogen Microbiological Response at LFU for Blood Only (ME at LFU Analysis Set)
Escherichia coli - Favorable (n=19, 18)
|
19 Participant
|
17 Participant
|
|
Per-pathogen Microbiological Response at LFU for Blood Only (ME at LFU Analysis Set)
Klebsiella pneumoniae - Favorable (n=2, 1)
|
2 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at LFU for Blood Only (ME at LFU Analysis Set)
Proteus mirabilis - Favorable (n=1, 0)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at LFU for Blood Only (ME at LFU Analysis Set)
Pseudomonas aeruginosa - Favorable (n=0, 1)
|
0 Participant
|
1 Participant
|
SECONDARY outcome
Timeframe: At TOC visit. TOC visit is 21 to 25 days from RandomizationPopulation: Microbiological modified intent to treat analysis set (mMITT)
Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the mMITT analysis set
Outcome measures
| Measure |
CAZ-AVI
n=393 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=417 Participants
Doripenem treatment group
|
|---|---|---|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
Entero. cloacae (MIC: 0.03)- Favorable (n= 1,0)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
Entero. cloacae (MIC: 0.06)- Favorable (n= 0, 1)
|
0 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
Entero. cloacae (MIC: 0.12)- Favorable (n= 3,2)
|
2 Participant
|
2 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
Entero. cloacae (MIC: 0.25)- Favorable (n= 1,4)
|
0 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
Entero. cloacae (MIC: 0.5)- Favorable (n= 1,1)
|
0 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
Entero. cloacae (MIC: 1)- Favorable (n= 2,5)
|
1 Participant
|
4 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
E. coli (MIC: <=0.008) - Favorable (n=5, 6)
|
3 Participant
|
5 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
E. coli (MIC: 0.015) - Favorable (n=8, 7)
|
8 Participant
|
6 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
E. coli (MIC: 0.03) - Favorable (n=28, 35)
|
24 Participant
|
23 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
E. coli (MIC: 0.06) - Favorable (n=123, 139)
|
103 Participant
|
111 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
E. coli (MIC: 0.12) - Favorable (n=90, 81)
|
67 Participant
|
54 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
E. coli (MIC: 0.25) - Favorable (n=28, 25)
|
18 Participant
|
13 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
E. coli (MIC: 0.5) - Favorable (n=5, 6)
|
4 Participant
|
2 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
E. coli (MIC: 1) - Favorable (n=3, 0)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
E. coli (MIC: 2) - Favorable (n=1, 0)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
E. coli (MIC: 4) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
E. coli (MIC: 8) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
E. coli (MIC: 16) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
E. coli (MIC: 32) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
E. coli (MIC: >32) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 0)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
Kleb. pneumoniae (MIC: 0.03) - Favorable (n=1, 2)
|
1 Participant
|
2 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
Kleb. pneumoniae (MIC: 0.06) - Favorable (n=9, 8)
|
7 Participant
|
8 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
Kleb.pneumoniae (MIC: 0.12) -Favorable(n=11, 10)
|
9 Participant
|
7 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
Kleb. pneumoniae (MIC: 0.25) - Favorable (n=4, 10)
|
1 Participant
|
3 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
Kleb. pneumoniae (MIC: 0.5) - Favorable (n=8, 16)
|
6 Participant
|
11 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
Kleb. pneumoniae (MIC: 1) - Favorable (n=8, 5)
|
6 Participant
|
3 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
Kleb. pneumoniae (MIC: 2) - Favorable (n= 2, 4)
|
2 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
Kleb. pneumoniae (MIC: 32) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
Kleb. pneumoniae (MIC: >32) - Favorable (n=0, 1)
|
0 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
Proteus mirabilis (MIC: 0.015)- Favorable (n=1,1)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
Proteus mirabilis (MIC: 0.03)- Favorable (n=10, 5)
|
10 Participant
|
3 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
Proteus mirabilis (MIC: 0.06)- Favorable (n=6,6)
|
5 Participant
|
5 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
Proteus mirabilis (MIC: 0.12)- Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
Proteus mirabilis (MIC: 0.25)- Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
Proteus mirabilis (MIC: 0.5)- Favorable (n=0,1)
|
0 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
Proteus mirabilis (MIC: 1)- Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
Proteus mirabilis (MIC: 2)- Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
Proteus mirabilis (MIC: 4)- Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
Proteus mirabilis (MIC: 8)- Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
Proteus mirabilis (MIC: 16)- Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
Proteus mirabilis (MIC: 32)- Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
Proteus mirabilis (MIC: >32)- Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
Entero. cloacae (MIC: 0.015)- Favorable (n= 0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
Entero. cloacae (MIC: 2)- Favorable (n= 1,0)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
Entero. cloacae (MIC: 4)- Favorable (n= 2,0)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
Entero. cloacae (MIC: 8)- Favorable (n= 0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
Entero. cloacae (MIC: 16)- Favorable (n= 0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
Entero. cloacae (MIC: 32)- Favorable (n= 0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
Entero. cloacae (MIC: >32)- Favorable (n= 0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
P.aeruginosa (MIC: 0.015) - Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
P.aeruginosa (MIC: 0.03) - Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
P.aeruginosa (MIC: 0.06) - Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
P.aeruginosa (MIC: 0.12) - Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
P.aeruginosa (MIC: 0.25) - Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
P.aeruginosa (MIC: 0.5) - Favorable (n=0,2)
|
0 Participant
|
2 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
P.aeruginosa (MIC: 1) - Favorable (n=1,4)
|
1 Participant
|
2 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
P.aeruginosa (MIC: 2) - Favorable (n=5,5)
|
5 Participant
|
5 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
P.aeruginosa (MIC: 4) - Favorable (n=7,6)
|
3 Participant
|
4 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
P.aeruginosa (MIC: 8) - Favorable (n=2,2)
|
1 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
P.aeruginosa (MIC: 16) - Favorable (n=1,1)
|
0 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
P.aeruginosa (MIC: 32) - Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
P.aeruginosa (MIC: >32) - Favorable (n=2,0)
|
2 Participant
|
0 Participant
|
SECONDARY outcome
Timeframe: At TOC visit. TOC visit is 21 to 25 days from RandomizationPopulation: Extended microbiological evaluable analysis set at TOC (EME at TOC)
Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the Extended ME at TOC analysis set
Outcome measures
| Measure |
CAZ-AVI
n=292 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=311 Participants
Doripenem treatment group
|
|---|---|---|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
E. coli (MIC: <=0.008) - Favorable (n=4,4)
|
2 Participant
|
4 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
E. coli (MIC: 0.015) - Favorable (n=5, 6)
|
5 Participant
|
5 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
E. coli (MIC: 0.03) - Favorable (n=18, 21)
|
17 Participant
|
17 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
E. coli (MIC: 0.06) - Favorable (n=95, 111)
|
83 Participant
|
94 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
E. coli (MIC: 0.12) - Favorable (n=68, 54)
|
56 Participant
|
40 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
E. coli (MIC: 0.25) - Favorable (n=19, 18)
|
13 Participant
|
8 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
E. coli (MIC: 0.5) - Favorable (n=2, 5)
|
2 Participant
|
2 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
E. coli (MIC: 1) - Favorable (n=2, 0)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
E. coli (MIC: 2) - Favorable (n=1, 0)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
E. coli (MIC: 4) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
E. coli (MIC: 8) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
E. coli (MIC: 16) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
E. coli (MIC: 32) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
E. coli (MIC: >32) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 0)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Kleb. pneumoniae (MIC: 0.03) - Favorable (n=1, 2)
|
1 Participant
|
2 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Kleb. pneumoniae (MIC: 0.06) - Favorable (n=5, 7)
|
4 Participant
|
7 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Kleb.pneumoniae (MIC: 0.12) -Favorable(n=8, 9)
|
7 Participant
|
6 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Kleb. pneumoniae (MIC: 0.25) - Favorable (n=3, 7)
|
1 Participant
|
2 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Kleb. pneumoniae (MIC: 0.5) - Favorable (n=6, 11)
|
4 Participant
|
8 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Kleb. pneumoniae (MIC: 1) - Favorable (n=6, 4)
|
6 Participant
|
3 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Kleb. pneumoniae (MIC: 2) - Favorable (n= 2, 1)
|
2 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Kleb. pneumoniae (MIC: 32) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Kleb. pneumoniae (MIC: >32) - Favorable (n=0, 1)
|
0 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Proteus mirabilis (MIC: 0.015)- Favorable (n=1,0)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Proteus mirabilis (MIC: 0.03)- Favorable (n=9, 2)
|
9 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Proteus mirabilis (MIC: 0.06)- Favorable (n=4,5)
|
4 Participant
|
4 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Proteus mirabilis (MIC: 0.12)- Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Proteus mirabilis (MIC: 0.25)- Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Proteus mirabilis (MIC: 0.5)- Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Proteus mirabilis (MIC: 1)- Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Proteus mirabilis (MIC: 2)- Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Proteus mirabilis (MIC: 4)- Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Proteus mirabilis (MIC: 8)- Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Proteus mirabilis (MIC: 16)- Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Proteus mirabilis (MIC: 32)- Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Proteus mirabilis (MIC: >32)- Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Entero. cloacae (MIC: 0.015)- Favorable (n= 0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Entero. cloacae (MIC: 0.03)- Favorable (n= 1,0)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Entero. cloacae (MIC: 0.06)- Favorable (n= 0, 1)
|
0 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Entero. cloacae (MIC: 0.12)- Favorable (n= 1,2)
|
1 Participant
|
2 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Entero. cloacae (MIC: 0.25)- Favorable (n= 0,3)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Entero. cloacae (MIC: 0.5)- Favorable (n= 1,1)
|
0 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Entero. cloacae (MIC: 1)- Favorable (n= 1,4)
|
1 Participant
|
4 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Entero. cloacae (MIC: 2)- Favorable (n= 1,0)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Entero. cloacae (MIC: 4)- Favorable (n= 2,0)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Entero. cloacae (MIC: 8)- Favorable (n= 0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Entero. cloacae (MIC: 16)- Favorable (n= 0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Entero. cloacae (MIC: 32)- Favorable (n= 0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Entero. cloacae (MIC: >32)- Favorable (n= 0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
P.aeruginosa (MIC: 0.015) - Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
P.aeruginosa (MIC: 0.03) - Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
P.aeruginosa (MIC: 0.06) - Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
P.aeruginosa (MIC: 0.12) - Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
P.aeruginosa (MIC: 0.25) - Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
P.aeruginosa (MIC: 0.5) - Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
P.aeruginosa (MIC: 1) - Favorable (n=1,4)
|
1 Participant
|
2 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
P.aeruginosa (MIC: 2) - Favorable (n=4,5)
|
4 Participant
|
5 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
P.aeruginosa (MIC: 4) - Favorable (n=5,6)
|
1 Participant
|
4 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
P.aeruginosa (MIC: 8) - Favorable (n=2,2)
|
1 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
P.aeruginosa (MIC: 16) - Favorable (n=0,1)
|
0 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
P.aeruginosa (MIC: 32) - Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
P.aeruginosa (MIC: >32) - Favorable (n=1,0)
|
1 Participant
|
0 Participant
|
SECONDARY outcome
Timeframe: At TOC visit. TOC visit is 21 to 25 days from RandomizationPopulation: Microbiological evaluable analysis set at TOC (ME at TOC)
Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the ME at TOC analysis set
Outcome measures
| Measure |
CAZ-AVI
n=286 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=298 Participants
Doripenem treatment group
|
|---|---|---|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
E. coli (MIC: >32) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
E. coli (MIC: <=0.008) - Favorable (n=4,4)
|
2 Participant
|
4 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
E. coli (MIC: 0.015) - Favorable (n=5, 6)
|
5 Participant
|
5 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
E. coli (MIC: 0.03) - Favorable (n=18, 21)
|
17 Participant
|
17 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
E. coli (MIC: 0.06) - Favorable (n=95, 111)
|
83 Participant
|
94 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
E. coli (MIC: 0.12) - Favorable (n=68, 54)
|
56 Participant
|
40 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
E. coli (MIC: 0.25) - Favorable (n=19, 18)
|
13 Participant
|
8 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
E. coli (MIC: 0.5) - Favorable (n=2, 5)
|
2 Participant
|
2 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
E. coli (MIC: 1) - Favorable (n=2, 0)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
E. coli (MIC: 2) - Favorable (n=1, 0)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
E. coli (MIC: 4) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
E. coli (MIC: 8) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
E. coli (MIC: 16) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
E. coli (MIC: 32) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 0)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
Kleb. pneumoniae (MIC: 0.03) - Favorable (n=1, 2)
|
1 Participant
|
2 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
Kleb. pneumoniae (MIC: 0.06) - Favorable (n=5, 7)
|
4 Participant
|
7 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
Kleb.pneumoniae (MIC: 0.12) -Favorable(n=8, 9)
|
7 Participant
|
6 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
Kleb. pneumoniae (MIC: 0.25) - Favorable (n=3, 7)
|
1 Participant
|
2 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
Kleb. pneumoniae (MIC: 0.5) - Favorable (n=6, 11)
|
4 Participant
|
8 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
Kleb. pneumoniae (MIC: 1) - Favorable (n=5, 4)
|
5 Participant
|
3 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
Kleb. pneumoniae (MIC: 2) - Favorable (n= 2, 1)
|
2 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
Kleb. pneumoniae (MIC: 32) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
Kleb. pneumoniae (MIC: >32) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
Proteus mirabilis (MIC: 0.015)- Favorable (n=1,0)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
Proteus mirabilis (MIC: 0.03)- Favorable (n=9, 2)
|
9 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
Proteus mirabilis (MIC: 0.06)- Favorable (n=4,5)
|
4 Participant
|
4 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
Proteus mirabilis (MIC: 0.12)- Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
Proteus mirabilis (MIC: 0.25)- Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
Proteus mirabilis (MIC: 0.5)- Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
Proteus mirabilis (MIC: 1)- Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
Proteus mirabilis (MIC: 2)- Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
Proteus mirabilis (MIC: 4)- Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
Proteus mirabilis (MIC: 8)- Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
Proteus mirabilis (MIC: 16)- Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
Proteus mirabilis (MIC: 32)- Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
Proteus mirabilis (MIC: >32)- Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
Entero. cloacae (MIC: 0.015)- Favorable (n= 0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
Entero. cloacae (MIC: 0.03)- Favorable (n= 1,0)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
Entero. cloacae (MIC: 0.06)- Favorable (n= 0, 1)
|
0 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
Entero. cloacae (MIC: 0.12)- Favorable (n= 1,2)
|
1 Participant
|
2 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
Entero. cloacae (MIC: 0.25)- Favorable (n= 0,3)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
Entero. cloacae (MIC: 0.5)- Favorable (n= 1,1)
|
0 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
Entero. cloacae (MIC: 1)- Favorable (n= 1,4)
|
1 Participant
|
4 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
Entero. cloacae (MIC: 2)- Favorable (n= 1,0)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
Entero. cloacae (MIC: 4)- Favorable (n= 2,0)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
Entero. cloacae (MIC: 8)- Favorable (n= 0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
Entero. cloacae (MIC: 16)- Favorable (n= 0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
Entero. cloacae (MIC: 32)- Favorable (n= 0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
Entero. cloacae (MIC: >32)- Favorable (n= 0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
P.aeruginosa (MIC: 0.015) - Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
P.aeruginosa (MIC: 0.03) - Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
P.aeruginosa (MIC: 0.06) - Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
P.aeruginosa (MIC: 0.12) - Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
P.aeruginosa (MIC: 0.25) - Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
P.aeruginosa (MIC: 0.5) - Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
P.aeruginosa (MIC: 1) - Favorable (n=1,4)
|
1 Participant
|
2 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
P.aeruginosa (MIC: 2) - Favorable (n=4,4)
|
4 Participant
|
4 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
P.aeruginosa (MIC: 4) - Favorable (n=3,4)
|
1 Participant
|
3 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
P.aeruginosa (MIC: 8) - Favorable (n=1,1)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
P.aeruginosa (MIC: 16) - Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
P.aeruginosa (MIC: 32) - Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
P.aeruginosa (MIC: >32) - Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
SECONDARY outcome
Timeframe: At TOC visit. TOC visit is 21 to 25 days from RandomizationPopulation: Microbiological modified intent to treat analysis set (mMITT)
Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the mMITT analysis set
Outcome measures
| Measure |
CAZ-AVI
n=393 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=417 Participants
Doripenem treatment group
|
|---|---|---|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
E. coli (MIC: <=0.008) - Favorable (n=1, 3)
|
1 Participant
|
3 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
E. coli (MIC: 0.015) - Favorable (n=160, 160)
|
127 Participant
|
119 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
E. coli (MIC: 0.03) - Favorable (n=112, 123)
|
89 Participant
|
86 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
E. coli (MIC: 0.06) - Favorable (n=14, 10)
|
10 Participant
|
4 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
E. coli (MIC: 0.12) - Favorable (n=3, 3)
|
1 Participant
|
2 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
E. coli (MIC: 0.25) - Favorable (n=1, 0)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
E. coli (MIC: 0.5) - Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
E. coli (MIC: 1) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
E. coli (MIC: 2) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
E. coli (MIC: 4) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
E. coli (MIC: 8) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
E. coli (MIC: 16) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
E. coli (MIC: >16) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 3)
|
1 Participant
|
2 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
Kleb. pneumoniae (MIC: 0.03)-Favorable (n=22, 27)
|
16 Participant
|
21 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
Kleb. pneumoniae (MIC: 0.06)- Favorable (n=11, 16)
|
10 Participant
|
7 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
Kleb.pneumoniae (MIC: 0.12) -Favorable(n=4,4)
|
2 Participant
|
2 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
Kleb. pneumoniae (MIC: 0.25) - Favorable (n=2,3)
|
1 Participant
|
2 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
Kleb. pneumoniae (MIC: 0.5) - Favorable (n=2, 1)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
Kleb. pneumoniae (MIC: 1) - Favorable (n=1, 0)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
Kleb. pneumoniae (MIC: 2) - Favorable (n= 0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 1)
|
0 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 1)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
Kleb. pneumoniae (MIC: >16) - Favorable (n=1, 0)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
Proteus mirabilis (MIC: 0.015)- Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
Proteus mirabilis (MIC: 0.03)- Favorable (n=1, 0)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
Proteus mirabilis (MIC: 0.06)- Favorable (n=2,2)
|
2 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
Proteus mirabilis (MIC: 0.12)- Favorable (n=6,5)
|
5 Participant
|
4 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
Proteus mirabilis (MIC: 0.25)- Favorable (n=6, 4)
|
6 Participant
|
2 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
Proteus mirabilis (MIC: 0.5)- Favorable (n=2,2)
|
2 Participant
|
2 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
Proteus mirabilis (MIC: 1)- Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
Proteus mirabilis (MIC: 2)- Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
Proteus mirabilis (MIC: 4)- Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
Proteus mirabilis (MIC: 8)- Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
Proteus mirabilis (MIC: 16)- Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
Proteus mirabilis (MIC: >16)- Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
Entero. cloacae (MIC: 0.015)- Favorable (n= 3,1)
|
2 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
Entero. cloacae (MIC: 0.03)- Favorable (n= 1,5)
|
1 Participant
|
2 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
Entero. cloacae (MIC: 0.06)- Favorable (n= 3, 1)
|
1 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
Entero. cloacae (MIC: 0.12)- Favorable (n= 0, 4)
|
0 Participant
|
4 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
Entero. cloacae (MIC: 0.25)- Favorable (n= 0,1)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
Entero. cloacae (MIC: 0.5)- Favorable (n= 4,0)
|
2 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
Entero. cloacae (MIC: 1)- Favorable (n= 0,1)
|
0 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
Entero. cloacae (MIC: 2)- Favorable (n= 0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
Entero. cloacae (MIC: 4)- Favorable (n= 0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
Entero. cloacae (MIC: 8)- Favorable (n= 0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
Entero. cloacae (MIC: 16)- Favorable (n= 0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
Entero. cloacae (MIC: >16)- Favorable (n= 0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
P.aeruginosa (MIC: 0.015) - Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
P.aeruginosa (MIC: 0.03) - Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
P.aeruginosa (MIC: 0.06) - Favorable (n=2,3)
|
2 Participant
|
3 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
P.aeruginosa (MIC: 0.12) - Favorable (n=2,2)
|
1 Participant
|
2 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
P.aeruginosa (MIC: 0.25) - Favorable (n=2,5)
|
2 Participant
|
2 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
P.aeruginosa (MIC: 0.5) - Favorable (n=2,1)
|
2 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
P.aeruginosa (MIC: 1) - Favorable (n=1,4)
|
0 Participant
|
3 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
P.aeruginosa (MIC: 2) - Favorable (n=1,0)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
P.aeruginosa (MIC: 4) - Favorable (n=2,2)
|
1 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
P.aeruginosa (MIC: 8) - Favorable (n=2,1)
|
1 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
P.aeruginosa (MIC: 16) - Favorable (n=2,1)
|
0 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
P.aeruginosa (MIC: >16) - Favorable (n=2,1)
|
2 Participant
|
1 Participant
|
SECONDARY outcome
Timeframe: At TOC visit. TOC visit is 21 to 25 days from RandomizationPopulation: Extended microbiological evaluable analysis set at TOC (EME at TOC)
Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the Extended ME at TOC analysis set
Outcome measures
| Measure |
CAZ-AVI
n=292 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=311 Participants
Doripenem treatment group
|
|---|---|---|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
E. coli (MIC: 4) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
E. coli (MIC: 8) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
E. coli (MIC: 16) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
E. coli (MIC: <=0.008) - Favorable (n=1,1)
|
1 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
E. coli (MIC: 0.015) - Favorable (n=122, 119)
|
106 Participant
|
95 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
E. coli (MIC: 0.03) - Favorable (n=79, 89)
|
64 Participant
|
70 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
E. coli (MIC: 0.06) - Favorable (n=10, 8)
|
7 Participant
|
3 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
E. coli (MIC: 0.12) - Favorable (n=1, 2)
|
1 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
E. coli (MIC: 0.25) - Favorable (n=1, 0)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
E. coli (MIC: 0.5) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
E. coli (MIC: 1) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
E. coli (MIC: 2) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
E. coli (MIC: >16) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 2)
|
1 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Kleb. pneumoniae (MIC:0.03) - Favorable (n=15, 23)
|
12 Participant
|
18 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Kleb. pneumoniae (MIC: 0.06) - Favorable (n=8, 12)
|
7 Participant
|
6 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Kleb.pneumoniae (MIC: 0.12) -Favorable(n=3, 2)
|
2 Participant
|
2 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Kleb. pneumoniae (MIC: 0.25) - Favorable (n=2, 2)
|
1 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Kleb. pneumoniae (MIC: 0.5) - Favorable (n=1, 0)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Kleb. pneumoniae (MIC: 1) - Favorable (n=1, 0)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Kleb. pneumoniae (MIC: 2) - Favorable (n= 0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 1)
|
0 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Kleb. pneumoniae (MIC: >16) - Favorable (n=1, 0)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Proteus mirabilis (MIC: 0.015)- Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Proteus mirabilis (MIC: 0.03)- Favorable (n=1,0)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Proteus mirabilis (MIC: 0.06)- Favorable (n=2,2)
|
2 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Proteus mirabilis (MIC: 0.12)- Favorable (n=4,2)
|
4 Participant
|
2 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Proteus mirabilis (MIC: 0.25)- Favorable (n=6, 3)
|
6 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Proteus mirabilis (MIC: 0.5)- Favorable (n=1,0)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Proteus mirabilis (MIC: 1)- Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Proteus mirabilis (MIC: 2)- Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Proteus mirabilis (MIC: 4)- Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Proteus mirabilis (MIC: 8)- Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Proteus mirabilis (MIC: 16)- Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Proteus mirabilis (MIC: >16)- Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Entero. cloacae (MIC: 0.015)- Favorable (n= 1,1)
|
1 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Entero. cloacae (MIC: 0.03)- Favorable (n= 1,4)
|
1 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Entero. cloacae (MIC: 0.06)- Favorable (n= 2, 1)
|
1 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Entero. cloacae (MIC: 0.12)- Favorable (n= 0,4)
|
0 Participant
|
4 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Entero. cloacae (MIC: 0.25)- Favorable (n= 0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Entero. cloacae (MIC: 0.5)- Favorable (n= 3,0)
|
2 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Entero. cloacae (MIC: 1)- Favorable (n= 0,1)
|
0 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Entero. cloacae (MIC: 2)- Favorable (n= 0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Entero. cloacae (MIC: 4)- Favorable (n= 0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Entero. cloacae (MIC: 8)- Favorable (n= 0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Entero. cloacae (MIC: 16)- Favorable (n= 0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Entero. cloacae (MIC: >16)- Favorable (n= 0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
P.aeruginosa (MIC: 0.015) - Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
P.aeruginosa (MIC: 0.03) - Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
P.aeruginosa (MIC: 0.06) - Favorable (n=2,3)
|
2 Participant
|
3 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
P.aeruginosa (MIC: 0.12) - Favorable (n=1,2)
|
0 Participant
|
2 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
P.aeruginosa (MIC: 0.25) - Favorable (n=2,4)
|
2 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
P.aeruginosa (MIC: 0.5) - Favorable (n=2,1)
|
2 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
P.aeruginosa (MIC: 1) - Favorable (n=1,3)
|
0 Participant
|
2 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
P.aeruginosa (MIC: 2) - Favorable (n=1,0)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
P.aeruginosa (MIC: 4) - Favorable (n=0,2)
|
0 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
P.aeruginosa (MIC: 8) - Favorable (n=1,1)
|
0 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
P.aeruginosa (MIC: 16) - Favorable (n=2,1)
|
0 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
P.aeruginosa (MIC: >16) - Favorable (n=1,1)
|
1 Participant
|
1 Participant
|
SECONDARY outcome
Timeframe: At TOC visit. TOC visit is 21 to 25 days from RandomizationPopulation: Microbiological evaluable analysis set at TOC (ME at TOC)
Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the ME at TOC analysis set
Outcome measures
| Measure |
CAZ-AVI
n=286 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
n=298 Participants
Doripenem treatment group
|
|---|---|---|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
E. coli (MIC: <=0.008) - Favorable (n=1,1)
|
1 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
E. coli (MIC: 0.015) - Favorable (n=122, 119)
|
106 Participant
|
95 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
E. coli (MIC: 0.03) - Favorable (n=79, 89)
|
64 Participant
|
70 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
E. coli (MIC: 0.06) - Favorable (n=10, 8)
|
7 Participant
|
3 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
E. coli (MIC: 0.12) - Favorable (n=1,2)
|
1 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
E. coli (MIC: 0.25) - Favorable (n=1,0)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
E. coli (MIC: 0.5) - Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
E. coli (MIC: 1) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
E. coli (MIC: 2) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
E. coli (MIC: 4) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
E. coli (MIC: 8) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
E. coli (MIC: 16) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
E. coli (MIC: >16) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 2)
|
1 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
Kleb. pneumoniae (MIC:0.03) - Favorable (n=15, 23)
|
12 Participant
|
18 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
Kleb. pneumoniae (MIC: 0.06) - Favorable (n=8, 12)
|
7 Participant
|
6 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
Kleb.pneumoniae (MIC: 0.12) -Favorable(n=3,2)
|
2 Participant
|
2 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
Kleb. pneumoniae (MIC: 0.25) - Favorable (n=2, 2)
|
1 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
Kleb. pneumoniae (MIC: 0.5) - Favorable (n=1,0)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
Kleb. pneumoniae (MIC: 1) - Favorable (n=1, 0)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
Kleb. pneumoniae (MIC: 2) - Favorable (n= 0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
Kleb. pneumoniae (MIC: >16) - Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
Proteus mirabilis (MIC: 0.015)- Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
Proteus mirabilis (MIC: 0.03)- Favorable (n=1, 0)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
Proteus mirabilis (MIC: 0.06)- Favorable (n=2,2)
|
2 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
Proteus mirabilis (MIC: 0.12)- Favorable (n=4,2)
|
4 Participant
|
2 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
Proteus mirabilis (MIC: 0.25)- Favorable (n=6, 3)
|
6 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
Proteus mirabilis (MIC: 0.5)- Favorable (n=1,0)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
Proteus mirabilis (MIC: 1)- Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
Proteus mirabilis (MIC: 2)- Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
Proteus mirabilis (MIC: 4)- Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
Proteus mirabilis (MIC: 8)- Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
Proteus mirabilis (MIC: 16)- Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
Proteus mirabilis (MIC: >16)- Favorable (n=0, 0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
Entero. cloacae (MIC: 0.015)- Favorable (n= 1,1)
|
1 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
Entero. cloacae (MIC: 0.03)- Favorable (n= 1,4)
|
1 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
Entero. cloacae (MIC: 0.06)- Favorable (n= 2, 1)
|
1 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
Entero. cloacae (MIC: 0.12)- Favorable (n= 0,4)
|
0 Participant
|
4 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
Entero. cloacae (MIC: 0.25)- Favorable (n= 0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
Entero. cloacae (MIC: 0.5)- Favorable (n= 3,0)
|
2 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
Entero. cloacae (MIC: 1)- Favorable (n= 0,1)
|
0 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
Entero. cloacae (MIC: 2)- Favorable (n= 0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
Entero. cloacae (MIC: 4)- Favorable (n= 0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
Entero. cloacae (MIC: 8)- Favorable (n= 0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
Entero. cloacae (MIC: 16)- Favorable (n= 0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
Entero. cloacae (MIC: >16)- Favorable (n= 0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
P.aeruginosa (MIC: 0.015) - Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
P.aeruginosa (MIC: 0.03) - Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
P.aeruginosa (MIC: 0.06) - Favorable (n=2,3)
|
2 Participant
|
3 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
P.aeruginosa (MIC: 0.12) - Favorable (n=1,2)
|
0 Participant
|
2 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
P.aeruginosa (MIC: 0.25) - Favorable (n=2,4)
|
2 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
P.aeruginosa (MIC: 0.5) - Favorable (n=2,1)
|
2 Participant
|
1 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
P.aeruginosa (MIC: 1) - Favorable (n=1,3)
|
0 Participant
|
2 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
P.aeruginosa (MIC: 2) - Favorable (n=1,0)
|
1 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
P.aeruginosa (MIC: 4) - Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
P.aeruginosa (MIC: 8) - Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
P.aeruginosa (MIC: 16) - Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
P.aeruginosa (MIC: >16) - Favorable (n=0,0)
|
0 Participant
|
0 Participant
|
SECONDARY outcome
Timeframe: within 15 minutes before/after dosePopulation: PK analysis set (ceftazidime within 15 minutes before/after dose)
Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.
Outcome measures
| Measure |
CAZ-AVI
n=480 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
Doripenem treatment group
|
|---|---|---|
|
Plasma Concentrations for Ceftazidime Within 15 Minutes Before/After Dose (PK Analysis Set)
|
65481.2 NG/ML
Interval 1260.0 to 3190000.0
|
—
|
SECONDARY outcome
Timeframe: Between 30 to 90 minutes after dosePopulation: PK analysis set (ceftazidime between 30 to 90 minutes after dose)
Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.
Outcome measures
| Measure |
CAZ-AVI
n=483 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
Doripenem treatment group
|
|---|---|---|
|
Plasma Concentrations for Ceftazidime Between 30 to 90 Minutes After Dose(PK Analysis Set)
|
47575.1 NG/ML
Interval 749.0 to 414000.0
|
—
|
SECONDARY outcome
Timeframe: Between 300 to 360 minutes after dosePopulation: PK analysis set (ceftazidime between 300 to 360 minutes after dose)
Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.
Outcome measures
| Measure |
CAZ-AVI
n=481 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
Doripenem treatment group
|
|---|---|---|
|
Plasma Concentrations for Ceftazidime Between 300 to 360 Minutes After Dose(PK Analysis Set)
|
16959.6 NG/ML
Interval 156.0 to 1640000.0
|
—
|
SECONDARY outcome
Timeframe: within 15 minutes before/after dosePopulation: PK analysis set (avibactam within 15 minutes before/after dose)
Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.
Outcome measures
| Measure |
CAZ-AVI
n=489 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
Doripenem treatment group
|
|---|---|---|
|
Plasma Concentrations for Avibactam Within 15 Minutes Before/After Dose (PK Analysis Set)
|
9307.3 NG/ML
Interval 125.0 to 1780000.0
|
—
|
SECONDARY outcome
Timeframe: Between 30 to 90 minutes after dosePopulation: PK analysis set (avibactam between 30 to 90 minutes after dose)
Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.
Outcome measures
| Measure |
CAZ-AVI
n=490 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
Doripenem treatment group
|
|---|---|---|
|
Plasma Concentrations for Avibactam Between 30 to 90 Minutes After Dose(PK Analysis Set)
|
6587.2 NG/ML
Interval 113.0 to 105000.0
|
—
|
SECONDARY outcome
Timeframe: Between 300 to 360 minutes after dosePopulation: PK analysis set (avibactam between 300 to 360 minutes after dose)
Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.
Outcome measures
| Measure |
CAZ-AVI
n=488 Participants
Ceftazidime-avibactam treatment group
|
Doripenem
Doripenem treatment group
|
|---|---|---|
|
Plasma Concentrations for Avibactam Between 300 to 360 Minutes After Dose(PK Analysis Set)
|
1883.2 NG/ML
Interval 26.0 to 336000.0
|
—
|
Adverse Events
CAZ-AVI
Serious events: 21 serious events
Other events: 67 other events
Deaths: 0 deaths
Doripenem
Serious events: 12 serious events
Other events: 57 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CAZ-AVI
n=511 participants at risk
Ceftazidime-avibactam treatment group
|
Doripenem
n=509 participants at risk
Doripenem treatment group
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.39%
2/511 • Number of events 2
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
0.00%
0/509
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
|
Cardiac disorders
Angina unstable
|
0.20%
1/511 • Number of events 1
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
0.20%
1/509 • Number of events 1
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/511
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
0.20%
1/509 • Number of events 1
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
|
Cardiac disorders
Coronary artery aneurysm
|
0.20%
1/511 • Number of events 1
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
0.00%
0/509
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/511
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
0.20%
1/509 • Number of events 1
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.20%
1/511 • Number of events 1
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
0.00%
0/509
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.20%
1/511 • Number of events 1
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
0.00%
0/509
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.20%
1/511 • Number of events 1
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
0.00%
0/509
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
|
Infections and infestations
Abdominal abscess
|
0.20%
1/511 • Number of events 1
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
0.00%
0/509
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/511
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
0.20%
1/509 • Number of events 1
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
|
Infections and infestations
Cellulitis
|
0.20%
1/511 • Number of events 1
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
0.00%
0/509
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
|
Infections and infestations
Chronic hepatitis C
|
0.20%
1/511 • Number of events 1
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
0.00%
0/509
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.20%
1/511 • Number of events 1
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
0.00%
0/509
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
|
Infections and infestations
Diverticulitis
|
0.20%
1/511 • Number of events 1
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
0.00%
0/509
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
|
Infections and infestations
Gastroenteritis
|
0.20%
1/511 • Number of events 1
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
0.00%
0/509
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
|
Infections and infestations
Orchitis
|
0.00%
0/511
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
0.20%
1/509 • Number of events 1
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/511
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
0.20%
1/509 • Number of events 1
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/511
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
0.20%
1/509 • Number of events 1
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/511
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
0.20%
1/509 • Number of events 1
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.20%
1/511 • Number of events 1
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
0.00%
0/509
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/511
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
0.20%
1/509 • Number of events 1
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.20%
1/511 • Number of events 1
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
0.00%
0/509
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.20%
1/511 • Number of events 1
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
0.00%
0/509
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/511
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
0.20%
1/509 • Number of events 1
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
|
Nervous system disorders
Hypoglycaemic seizure
|
0.00%
0/511
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
0.20%
1/509 • Number of events 1
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/511
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
0.20%
1/509 • Number of events 1
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.20%
1/511 • Number of events 1
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
0.00%
0/509
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.20%
1/511 • Number of events 1
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
0.00%
0/509
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.59%
3/511 • Number of events 4
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
0.00%
0/509
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/511
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
0.20%
1/509 • Number of events 1
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
|
Renal and urinary disorders
Renal impairment
|
0.20%
1/511 • Number of events 1
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
0.00%
0/509
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/511
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
0.20%
1/509 • Number of events 1
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.20%
1/511 • Number of events 1
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
0.00%
0/509
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.20%
1/511 • Number of events 1
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
0.00%
0/509
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
Other adverse events
| Measure |
CAZ-AVI
n=511 participants at risk
Ceftazidime-avibactam treatment group
|
Doripenem
n=509 participants at risk
Doripenem treatment group
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
2.2%
11/511 • Number of events 11
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
1.4%
7/509 • Number of events 8
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.5%
13/511 • Number of events 14
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
1.2%
6/509 • Number of events 6
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
|
Gastrointestinal disorders
Nausea
|
2.9%
15/511 • Number of events 16
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
2.0%
10/509 • Number of events 10
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
|
Nervous system disorders
Headache
|
7.4%
38/511 • Number of events 41
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
7.9%
40/509 • Number of events 41
The summaries for adverse events are based on the safety analysis set. There is a total of 1020 patients in safety analysis set in both protocol D4280C00002 (i.e. 517 patients) and protocol D4280C00004 (i.e. 503 patients). A total of 13 patients (out of the1033 randomized patients) did not receive any amount of IV study therapy.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Principal investigator submits the proposed publication and /or presentation to AZAB for review at least 60 days prior to proposed publication and/or presentation. If AZAB, requests in writing, then PI shall withhold publication and/or presentation for an additional 90 days to allow AZAB to protect its intellectual rights.
- Publication restrictions are in place
Restriction type: OTHER