A Phase 4 interventional study of Zavicefta, Ceftazidime-Avibactam and Best Available Treatment in Urinary Tract Infection, Acute Pyelonephritis and Hospital Acquired Pneumonia, sponsored by Pfizer. Completed at 37 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-21.
Sponsored by Pfizer · Phase 4, Interventional, and Treatment
Among 26 studies in Urinary Tract Infections with a site in China — 6 open to participants now, 6 under way, none of them phase 3. Urinary Tract Infections · China.
Among the 26 studies in Urinary Tract Infections with a site in China, this one is the 19th largest by enrollment of the 22 interventional ones, is one of 4 that started in 2021, is one of 2 in phase 4, and was the 10th registered.
803 studies on the registry are indexed under Urinary Tract Infections; 133 are open to participants now.
This study's enrollment of 60 is below the median of 131 across 560 interventional studies indexed under Urinary Tract Infections.
Browse Urinary Tract Infections studies →6 of the 26 studies in Urinary Tract Infections with a site in China are open now, in 1 country. Each count lists the studies.
Of the 84 Urinary Tract Infections studies recruiting now, 50 (60%) set no upper age limit and 23 (27%) stop at 75 or younger; 15 take children under 18; 17 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →26 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 4 started in 2021.
Median enrollment 150 across the 22 interventional studies, 219 across the 4 observational. Of the 17 that completed or were terminated, 4 (24%) have results posted.
15 of 26 have an industry lead sponsor. The 10 most frequent:
Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
Pfizer has 8 studies filed under Urinary Tract Infections — fewer than ten, so there is no comparison to draw.
1 of the studies in Urinary Tract Infections with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07719257Zhuhai United Laboratories Co., Ltd.Evaluation of the Safety, Tolerability and Pharmacokinetics of TUL108 for Injection in Healthy Participants (SAD/ MAD) | 2026-12-30 |
Among the 26 studies in Urinary Tract Infections with a site in China, from their registry updates:
This is an open-label, randomized, multi-center, interventional, active-controlled Phase 4 study to evaluate the efficacy and safety of CAZ-AVI versus BAT in the treatment of infected participants with selected infection types (Hospital Acquired Pneumonia [HAP] (including Ventilator-Associated Pneumonia [VAP]); Complicated Urinary-Tract Infection [cUTI]; Complicated Intra-Abdominal Infection [cIAI]; Bloodstream Infection [BSI]) due to carbapenem-resistant Gram-negative pathogens in China.This study will be an estimation study. The statistical inference will be based on point estimate and confidence interval.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ceftazidime 2g plus avibactam 0.5g
Drug: Zavicefta, Ceftazidime-Avibactam
Based on investigative site practice and local epidemiology and guideline
Drug: Best Available Treatment
CAZ-AVI 2.5 g (2 g ceftazidime + 0.5 g avibactam) administered IV as a 2 hour infusion every 8 hours. Dose adjustments are available for participants with CrCL ≤50 mL/min.
main treatment expected to be used as either monotherapy or in combination are colistin, tigecycline, fosfomycin, amikacin, and meropenem
Percentage of Participants With Clinical Cure at Test of Cure (TOC) Visit - Microbiologically Modified Intent-to-Treat (mMITT) Analysis Set
Clinical cure was defined as improvement in baseline signs and symptoms such that no further antimicrobial treatment was required for the index infection (i.e, complicated intra-abdominal infection \[cIAI\], complicated urinary-tract infection \[cUTI\], hospital-acquired pneumonia/ventilator-associated pneumonia \[HAP/VAP\] or bloodstream infection \[BSI\]) after study treatment. Also, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. The clinical response was assessed by the independent adjudication committee. 95 percent (%) confidence interval (CI) was calculated using Jeffrey's method.
Time frame: At TOC visit (From Day 21 up to Day 24)
Percentage of Participants With Clinical Cure at TOC Visit - Microbiologically Evaluable (ME) Analysis Set
Clinical cure: improvement in baseline signs and symptoms such that no further antimicrobial treatment was required for index infection (i.e. cIAI, cUTI, HAP/VAP or BSI) after study treatment. Also, for cIAI participants, no unplanned drainage or surgical intervention was necessary since initial procedure. 95% CI based on Jeffrey's method. ME analysis set (sub-set of mMITT): participants who received 3 days of study intervention, or received study intervention for \>=48 hours with \>= 80% compliance, or for \<48 hours before discontinuation due to adverse event, no concomitant antibiotics against baseline carbapenem-resistant gram negative pathogens between first dose and TOC (excluding participants with failed study therapy requiring additional antibiotics), had baseline organisms genetically confirmed by central microbiological testing, no indeterminate clinical outcome at end of treatment (EOT) or TOC visits, no important protocol deviations that affect assessment of efficacy.
Time frame: At TOC visit (From Day 21 up to Day 24)
Percentage of Participants With Clinical Cure at End of Treatment (EOT) Visit -mMITT Analysis Set
Clinical cure was defined as improvement in baseline signs and symptoms such that no further antimicrobial treatment was required for the index infection (i.e., cIAI, cUTI, HAP/VAP or BSI) after study treatment. Also, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. The clinical response was assessed by the independent adjudication committee. 95% CI was calculated using Jeffrey's method.
Time frame: At EOT visit (up to 24 hours after the last infusion on Day 14)
Percentage of Participants With Clinical Cure at EOT Visit - ME Analysis Set
Clinical cure: improvement in baseline signs and symptoms such that no further antimicrobial treatment was required for index infection (i.e., cIAI, cUTI, HAP/VAP or BSI) after study treatment. Also, for cIAI participants, no unplanned drainage or surgical intervention was necessary since initial procedure. 95% CI based on Jeffrey's method. ME analysis set (sub-set of mMITT): participants who received 3 days of study intervention, or received study intervention for \>=48 hours with \>= 80% compliance, or for \<48 hours before discontinuation due to adverse event, no concomitant antibiotics against baseline carbapenem-resistant gram negative pathogens between first dose and TOC (excluding participants with failed study therapy requiring additional antibiotics), had baseline organisms genetically confirmed by central microbiological testing, no indeterminate clinical outcome at EOT or TOC visits, no important protocol deviations that affect assessment of efficacy.
Time frame: At EOT visit (up to 24 hours after the last infusion on Day 14)
Percentage of Participants With Favorable Per-Participant Microbiological Response at TOC Visit - mMITT Analysis Set
Favorable microbiological response was defined as eradication or presumed eradication. Eradication was defined as absence (or urine quantification \<10\^3 colony forming units per milliliter \[CFU/mL\] for cUTI participants) of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication was defined as repeat culture of specimens were not performed/ clinically indicated in a participant who had a clinical response of cure (specific to cIAI and HAP/VAP participants). 95% CI was calculated using Jeffrey's method.
Time frame: At TOC visit (From Day 21 up to Day 24)
Percentage of Participants With Favorable Per-Participant Microbiological Response at TOC Visit - ME Analysis Set
Favorable microbiological response=eradication: absence (or urine quantification \<10\^3 CFU/mL for cUTI participants) of causative pathogen from appropriately obtained specimen at site of infection or presumed eradication: repeat culture of specimens were not performed/clinically indicated in participant who had clinical cure (specific to cIAI,HAP/VAP participants). 95% CI was calculated using Jeffrey's method. ME analysis set: participants received 3 days of study intervention,or received study intervention for \>= 48 hours with \>=80% compliance or for \<48 hours before discontinuation due to adverse event, no concomitant antibiotics against baseline carbapenem-resistant gram negative pathogens between first dose and TOC (excluding participants with failed study therapy requiring additional antibiotics), had baseline organisms confirmed by central microbiological testing, no indeterminate clinical outcome at EOT/TOC, no important protocol deviations that affect assessment of efficacy.
Time frame: At TOC visit (From Day 21 up to Day 24)
Percentage of Participants With Favorable Per-Participant Microbiological Response at EOT Visit - mMITT Analysis Set
Favorable microbiological response was defined as eradication or presumed eradication. Eradication was defined as absence (or urine quantification \<10\^3 CFU/mL for cUTI participants) of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication was defined as repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure (specific to cIAI and HAP/VAP participants). 95% CI was calculated using Jeffrey's method.
Time frame: At EOT visit (Up to 24 hours after last infusion on Day 14)
Percentage of Participants With Favorable Per-Participant Microbiological Response at EOT Visit - ME Analysis Set
Favorable microbiological response=eradication: absence (or urine quantification \<10\^3 CFU/mL for cUTI participants) of causative pathogen from appropriately obtained specimen at site of infection or presumed eradication: repeat culture of specimens were not performed/clinically indicated in participant who had clinical cure (specific to cIAI,HAP/VAP participants). 95% CI was calculated using Jeffrey's method. ME analysis set: participants received 3 days of study intervention,or received study intervention for \>= 48 hours with \>=80% compliance or for \<48 hours before discontinuation due to adverse event, no concomitant antibiotics against baseline carbapenem-resistant gram negative pathogens between first dose and TOC (excluding participants with failed study therapy requiring additional antibiotics), had baseline organisms confirmed by central microbiological testing, no indeterminate clinical outcome at EOT/TOC, no important protocol deviations that affect assessment of efficacy.
Time frame: At EOT visit (Up to 24 hours after last infusion on Day 14)
Percentage of Participants With Favorable Per-Pathogen Microbiological Response at TOC Visit - mMITT Analysis Set
Favorable microbiological response was defined as eradication or presumed eradication. Eradication was defined as absence (or urine quantification \<10\^3 CFU/mL for cUTI participants) of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication was defined as repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure (specific to cIAI and HAP/VAP participants). 95% CI was calculated using Jeffrey's method.
Time frame: At TOC visit (From Day 21 up to Day 24)
Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT Visit - mMITT Analysis Set
Favorable microbiological response was defined as eradication or presumed eradication. Eradication was defined as absence (or urine quantification \<10\^3 CFU/mL for cUTI participants) of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication was defined as repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure (specific to cIAI and HAP/VAP participants). 95% CI was calculated using Jeffrey's method.
Time frame: At EOT visit (Up to 24 hours after last infusion on Day 14)
Percentage of Participants Who Died Due to Any Cause Until Day 28
Percentage of participants who died due to any cause up to Day 28 was reported in this outcome measure. The 95% CI was calculated using the Jeffrey's method.
Time frame: From first dose of study intervention (Day 1) up to Day 28
Number of Participants With Treatment-Emergent Adverse Events
An adverse event (AE) was any untoward medical occurrence in a study participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent adverse event (TEAE) was any AE that started after the study intervention start date and time.
Time frame: From start of study treatment on Day 1 up to 32 days after the last dose of study intervention (Up to 46 days)
Number of Participants With Discontinuation Due to Adverse Events
Number of participants who discontinued the study due to adverse events were reported in this outcome measure. Discontinuations from study due to TEAEs included all participants with an AE record indicating that the AE caused permanent discontinuation from the study. Permanent discontinuations from any study intervention due to TEAEs included participants with an AE record indicating that action taken with study treatment was drug withdrawn but AE did not cause the participant to be discontinued from study.
Time frame: From start of study treatment on Day 1 up to 32 days after the last dose of study intervention (Up to 46 days)
Number of Participants With Potentially Clinically Significant Post-baseline Hematology Values
Potentially clinically significant hematology parameters included Hemoglobin (gram/deciliter), Hematocrit (%), Erythrocytes (10\^12/Liter \[L\]): value \< 0.8\*lower limit of normal (LLN) and change (Chg) \> 20% decrease, value \> 1.3\*upper limit of normal (ULN) and Chg \> 30% increase. Platelets (10\^9/L): Value \< 0.65\*LLN and Chg \> 50% decrease, Value \> 1.5\*ULN and Chg \> 100% increase. Leukocytes (10\^9/L): Value \< 0.65\*LLN and Chg \> 60% decrease, Value \> 1.6\*ULN and Chg \> 100% increase. Lymphocytes (10\^9/L): Value \< 0.25\*LLN and Chg \> 75% decrease, Value \> 1.5\*ULN and Chg \> 100% increase. Neutrophils (10\^9/L): Value \< 0.65\*LLN and Chg \> 75% decrease, Value \> 1.6\*ULN and Chg \> 100% increase. Basophils (10\^9/L), Eosinophils (10\^9/L), Monocytes (10\^9/L): Value \> 4.0\*ULN and Chg \> 300% increase. Number of participants with potentially clinically significant values for any hematology parameters were reported in this outcome measure.
Time frame: From first dose of study treatment (Day 1) until TOC (Up to Day 24)
Number of Participants With Potentially Clinically Significant Post-baseline Clinical Chemistry Values
Potentially clinically significant criteria included Bilirubin(mg/dL): \>2.0\*ULN and Chg \>150% increase (inc).Aspartate Aminotransferase,Alanine Aminotransferase(Units/Liter\[U/L\]):\>3.0\*ULN and Chg \>200% inc.Alkaline Phosphatase(U/L):\<0.5\*LLN and Chg \>80% decrease (dec),\> 2.0\*ULN and Chg \>100% inc.Protein,Albumin(g/dL):\<0.5\*LLN and Chg \>50% dec,\>1.5\*ULN and Chg \>50% inc.Blood Urea Nitrogen(mg/dL):\<0.2\*LLN and Chg \>100% dec, \>3.0\*ULN and Chg \>200% inc.Creatinine(mg/dL):\>2.0\*ULN and Chg \>100% inc.Sodium(milliequivalent\[mEq\]/L):\<0.85\*LLN and Chg \>10% dec, \>1.1\*ULN and Chg \>10% inc.Potassium,Chloride(mEq/L):\<0.8\*LLN and Chg \>20% dec, \>1.2\*ULN and Chg \>20% inc.Calcium(mg/dL):\<0.7\*LLN and Chg \>30% dec,\> 1.3\*ULN and Chg \>30% inc.Bicarbonate(mEq/L):\<0.7\*LLN and Chg \>40% dec, \>1.3\*ULN and Chg \>40% inc.Glucose(mg/dL):\<0.6\*LLN and Chg \>40% dec, \>3.0\*ULN and Chg \>200% inc.Number of participants with potentially clinically significant values for any clinical chemistry parameters were reported.
Time frame: From first dose of study treatment (Day 1) until TOC (Up to Day 24)
| Milestone | Ceftazidime-Avibactam | Best Available Treatment |
|---|---|---|
| Started | 31 | 29 |
| Safety analysis set | 30 | 29 |
| Completed | 24 | 17 |
| Not completed | 7 | 12 |
| Withdrew: Death | 6 | 9 |
| Withdrew: Withdrawal by subject | 0 | 3 |
| Withdrew: Randomized not treated | 1 | 0 |
Clinical cure was defined as improvement in baseline signs and symptoms such that no further antimicrobial treatment was required for the index infection (i.e, complicated intra-abdominal infection \[cIAI\], complicated urinary-tract infection \[cUTI\], hospital-acquired pneumonia/ventilator-associated pneumonia \[HAP/VAP\] or bloodstream infection \[BSI\]) after study treatment. Also, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. The clinical response was assessed by the independent adjudication committee. 95 percent (%) confidence interval (CI) was calculated using Jeffrey's method.
| Percentage of participants | Ceftazidime-Avibactam | Best Available Treatment |
|---|---|---|
| Percentage of Participants With Clinical Cure at Test of Cure (TOC) Visit - Microbiologically Modified Intent-to-Treat (mMITT) Analysis Set | 59.3 (40.6 to 76.1) | 25.9 (12.4 to 44.3) |
Clinical cure: improvement in baseline signs and symptoms such that no further antimicrobial treatment was required for index infection (i.e. cIAI, cUTI, HAP/VAP or BSI) after study treatment. Also, for cIAI participants, no unplanned drainage or surgical intervention was necessary since initial procedure. 95% CI based on Jeffrey's method. ME analysis set (sub-set of mMITT): participants who received 3 days of study intervention, or received study intervention for \>=48 hours with \>= 80% compliance, or for \<48 hours before discontinuation due to adverse event, no concomitant antibiotics against baseline carbapenem-resistant gram negative pathogens between first dose and TOC (excluding participants with failed study therapy requiring additional antibiotics), had baseline organisms genetically confirmed by central microbiological testing, no indeterminate clinical outcome at end of treatment (EOT) or TOC visits, no important protocol deviations that affect assessment of efficacy.
| Percentage of participants | Ceftazidime-Avibactam | Best Available Treatment |
|---|---|---|
| Percentage of Participants With Clinical Cure at TOC Visit - Microbiologically Evaluable (ME) Analysis Set | 78.6 (53.1 to 93.6) | 26.3 (10.8 to 48.4) |
Clinical cure was defined as improvement in baseline signs and symptoms such that no further antimicrobial treatment was required for the index infection (i.e., cIAI, cUTI, HAP/VAP or BSI) after study treatment. Also, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. The clinical response was assessed by the independent adjudication committee. 95% CI was calculated using Jeffrey's method.
| Percentage of participants | Ceftazidime-Avibactam | Best Available Treatment |
|---|---|---|
| Percentage of Participants With Clinical Cure at End of Treatment (EOT) Visit -mMITT Analysis Set | 66.7 (47.9 to 82.1) | 29.6 (15.1 to 48.2) |
Clinical cure: improvement in baseline signs and symptoms such that no further antimicrobial treatment was required for index infection (i.e., cIAI, cUTI, HAP/VAP or BSI) after study treatment. Also, for cIAI participants, no unplanned drainage or surgical intervention was necessary since initial procedure. 95% CI based on Jeffrey's method. ME analysis set (sub-set of mMITT): participants who received 3 days of study intervention, or received study intervention for \>=48 hours with \>= 80% compliance, or for \<48 hours before discontinuation due to adverse event, no concomitant antibiotics against baseline carbapenem-resistant gram negative pathogens between first dose and TOC (excluding participants with failed study therapy requiring additional antibiotics), had baseline organisms genetically confirmed by central microbiological testing, no indeterminate clinical outcome at EOT or TOC visits, no important protocol deviations that affect assessment of efficacy.
| Percentage of participants | Ceftazidime-Avibactam | Best Available Treatment |
|---|---|---|
| Percentage of Participants With Clinical Cure at EOT Visit - ME Analysis Set | 78.6 (53.1 to 93.6) | 31.6 (14.4 to 53.9) |
Favorable microbiological response was defined as eradication or presumed eradication. Eradication was defined as absence (or urine quantification \<10\^3 colony forming units per milliliter \[CFU/mL\] for cUTI participants) of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication was defined as repeat culture of specimens were not performed/ clinically indicated in a participant who had a clinical response of cure (specific to cIAI and HAP/VAP participants). 95% CI was calculated using Jeffrey's method.
| Percentage of participants | Ceftazidime-Avibactam | Best Available Treatment |
|---|---|---|
| Percentage of Participants With Favorable Per-Participant Microbiological Response at TOC Visit - mMITT Analysis Set | 59.3 (40.6 to 76.1) | 25.9 (12.4 to 44.3) |
Favorable microbiological response=eradication: absence (or urine quantification \<10\^3 CFU/mL for cUTI participants) of causative pathogen from appropriately obtained specimen at site of infection or presumed eradication: repeat culture of specimens were not performed/clinically indicated in participant who had clinical cure (specific to cIAI,HAP/VAP participants). 95% CI was calculated using Jeffrey's method. ME analysis set: participants received 3 days of study intervention,or received study intervention for \>= 48 hours with \>=80% compliance or for \<48 hours before discontinuation due to adverse event, no concomitant antibiotics against baseline carbapenem-resistant gram negative pathogens between first dose and TOC (excluding participants with failed study therapy requiring additional antibiotics), had baseline organisms confirmed by central microbiological testing, no indeterminate clinical outcome at EOT/TOC, no important protocol deviations that affect assessment of efficacy.
| Percentage of participants | Ceftazidime-Avibactam | Best Available Treatment |
|---|---|---|
| Percentage of Participants With Favorable Per-Participant Microbiological Response at TOC Visit - ME Analysis Set | 71.4 (45.5 to 89.5) | 31.6 (14.4 to 53.9) |
Favorable microbiological response was defined as eradication or presumed eradication. Eradication was defined as absence (or urine quantification \<10\^3 CFU/mL for cUTI participants) of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication was defined as repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure (specific to cIAI and HAP/VAP participants). 95% CI was calculated using Jeffrey's method.
| Percentage of participants | Ceftazidime-Avibactam | Best Available Treatment |
|---|---|---|
| Percentage of Participants With Favorable Per-Participant Microbiological Response at EOT Visit - mMITT Analysis Set | 81.5 (64.1 to 92.6) | 33.3 (17.9 to 52.1) |
Favorable microbiological response=eradication: absence (or urine quantification \<10\^3 CFU/mL for cUTI participants) of causative pathogen from appropriately obtained specimen at site of infection or presumed eradication: repeat culture of specimens were not performed/clinically indicated in participant who had clinical cure (specific to cIAI,HAP/VAP participants). 95% CI was calculated using Jeffrey's method. ME analysis set: participants received 3 days of study intervention,or received study intervention for \>= 48 hours with \>=80% compliance or for \<48 hours before discontinuation due to adverse event, no concomitant antibiotics against baseline carbapenem-resistant gram negative pathogens between first dose and TOC (excluding participants with failed study therapy requiring additional antibiotics), had baseline organisms confirmed by central microbiological testing, no indeterminate clinical outcome at EOT/TOC, no important protocol deviations that affect assessment of efficacy.
| Percentage of participants | Ceftazidime-Avibactam | Best Available Treatment |
|---|---|---|
| Percentage of Participants With Favorable Per-Participant Microbiological Response at EOT Visit - ME Analysis Set | 78.6 (53.1 to 93.6) | 42.1 (22.3 to 64.1) |
Favorable microbiological response was defined as eradication or presumed eradication. Eradication was defined as absence (or urine quantification \<10\^3 CFU/mL for cUTI participants) of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication was defined as repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure (specific to cIAI and HAP/VAP participants). 95% CI was calculated using Jeffrey's method.
| Percentage of participants | Ceftazidime-Avibactam | Best Available Treatment |
|---|---|---|
| Enterococcus Faecium | — | 0 (0.0 to 85.3) |
| Escherichia Coli | 100.0 (14.7 to 100.0) | — |
| Klebsiella Pneumoniae | 63.2 (40.9 to 81.8) | 30.4 (14.8 to 50.7) |
| Pseudomonas Aeruginosa | 37.5 (11.9 to 70.5) | 0 (0.0 to 44.5) |
| Staphylococcus Aureus | 0 (0.0 to 85.3) | — |
| Staphylococcus Capitis Subspecies | 100.0 (14.7 to 100.0) | — |
Favorable microbiological response was defined as eradication or presumed eradication. Eradication was defined as absence (or urine quantification \<10\^3 CFU/mL for cUTI participants) of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication was defined as repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure (specific to cIAI and HAP/VAP participants). 95% CI was calculated using Jeffrey's method.
| Percentage of participants | Ceftazidime-Avibactam | Best Available Treatment |
|---|---|---|
| Enterococcus Faecium | — | 0 (0.0 to 85.3) |
| Escherichia Coli | 100.0 (14.7 to 100.0) | — |
| Klebsiella Pneumoniae | 89.5 (70.3 to 97.7) | 39.1 (21.4 to 59.4) |
| Pseudomonas Aeruginosa | 75.0 (40.8 to 94.4) | 0 (0.0 to 44.5) |
| Staphylococcus Aureus | 0 (0.0 to 85.3) | — |
| Staphylococcus Capitis Subspecies | 100.0 (14.7 to 100.0) | — |
Percentage of participants who died due to any cause up to Day 28 was reported in this outcome measure. The 95% CI was calculated using the Jeffrey's method.
| Percentage of participants | Ceftazidime-Avibactam | Best Available Treatment |
|---|---|---|
| Percentage of Participants Who Died Due to Any Cause Until Day 28 | 13.3 (4.7 to 28.7) | 13.8 (4.8 to 29.5) |
An adverse event (AE) was any untoward medical occurrence in a study participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent adverse event (TEAE) was any AE that started after the study intervention start date and time.
| Participants | Ceftazidime-Avibactam | Best Available Treatment |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events | 24 | 26 |
Number of participants who discontinued the study due to adverse events were reported in this outcome measure. Discontinuations from study due to TEAEs included all participants with an AE record indicating that the AE caused permanent discontinuation from the study. Permanent discontinuations from any study intervention due to TEAEs included participants with an AE record indicating that action taken with study treatment was drug withdrawn but AE did not cause the participant to be discontinued from study.
| Participants | Ceftazidime-Avibactam | Best Available Treatment |
|---|---|---|
| Discontinuations from study due to TEAEs | 0 | 0 |
| Permanent discontinuations from any study intervention due to TEAEs | 1 | 6 |
Potentially clinically significant hematology parameters included Hemoglobin (gram/deciliter), Hematocrit (%), Erythrocytes (10\^12/Liter \[L\]): value \< 0.8\*lower limit of normal (LLN) and change (Chg) \> 20% decrease, value \> 1.3\*upper limit of normal (ULN) and Chg \> 30% increase. Platelets (10\^9/L): Value \< 0.65\*LLN and Chg \> 50% decrease, Value \> 1.5\*ULN and Chg \> 100% increase. Leukocytes (10\^9/L): Value \< 0.65\*LLN and Chg \> 60% decrease, Value \> 1.6\*ULN and Chg \> 100% increase. Lymphocytes (10\^9/L): Value \< 0.25\*LLN and Chg \> 75% decrease, Value \> 1.5\*ULN and Chg \> 100% increase. Neutrophils (10\^9/L): Value \< 0.65\*LLN and Chg \> 75% decrease, Value \> 1.6\*ULN and Chg \> 100% increase. Basophils (10\^9/L), Eosinophils (10\^9/L), Monocytes (10\^9/L): Value \> 4.0\*ULN and Chg \> 300% increase. Number of participants with potentially clinically significant values for any hematology parameters were reported in this outcome measure.
| Participants | Ceftazidime-Avibactam | Best Available Treatment |
|---|---|---|
| Number of Participants With Potentially Clinically Significant Post-baseline Hematology Values | 7 | 13 |
Potentially clinically significant criteria included Bilirubin(mg/dL): \>2.0\*ULN and Chg \>150% increase (inc).Aspartate Aminotransferase,Alanine Aminotransferase(Units/Liter\[U/L\]):\>3.0\*ULN and Chg \>200% inc.Alkaline Phosphatase(U/L):\<0.5\*LLN and Chg \>80% decrease (dec),\> 2.0\*ULN and Chg \>100% inc.Protein,Albumin(g/dL):\<0.5\*LLN and Chg \>50% dec,\>1.5\*ULN and Chg \>50% inc.Blood Urea Nitrogen(mg/dL):\<0.2\*LLN and Chg \>100% dec, \>3.0\*ULN and Chg \>200% inc.Creatinine(mg/dL):\>2.0\*ULN and Chg \>100% inc.Sodium(milliequivalent\[mEq\]/L):\<0.85\*LLN and Chg \>10% dec, \>1.1\*ULN and Chg \>10% inc.Potassium,Chloride(mEq/L):\<0.8\*LLN and Chg \>20% dec, \>1.2\*ULN and Chg \>20% inc.Calcium(mg/dL):\<0.7\*LLN and Chg \>30% dec,\> 1.3\*ULN and Chg \>30% inc.Bicarbonate(mEq/L):\<0.7\*LLN and Chg \>40% dec, \>1.3\*ULN and Chg \>40% inc.Glucose(mg/dL):\<0.6\*LLN and Chg \>40% dec, \>3.0\*ULN and Chg \>200% inc.Number of participants with potentially clinically significant values for any clinical chemistry parameters were reported.
| Participants | Ceftazidime-Avibactam | Best Available Treatment |
|---|---|---|
| Number of Participants With Potentially Clinically Significant Post-baseline Clinical Chemistry Values | 4 | 7 |
Collected over From start of study intervention on Day 1 up to 32 days after the last dose of study intervention (up to 46 days). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ceftazidime-Avibactam | 6/30 (20%) | 7/30 (23.3%) | 17/30 (56.7%) |
| Best Available Treatment | 9/29 (31%) | 11/29 (37.9%) | 18/29 (62.1%) |
| Event | Ceftazidime-Avibactam | Best Available Treatment |
|---|---|---|
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 2/30 | 3/29 |
| Septic shockInfections and infestations | 1/30 | 2/29 |
| ShockVascular disorders | 0/30 | 2/29 |
| Cardiac arrestCardiac disorders | 0/30 | 1/29 |
| Cardiac failure acuteCardiac disorders | 0/30 | 1/29 |
| Gastrointestinal haemorrhageGastrointestinal disorders | 1/30 | 1/29 |
| Large intestinal obstructionGastrointestinal disorders | 0/30 | 1/29 |
| Upper gastrointestinal haemorrhageGastrointestinal disorders | 0/30 | 1/29 |
| DeathGeneral disorders | 0/30 | 1/29 |
| PyrexiaGeneral disorders | 0/30 | 1/29 |
| Event | Ceftazidime-Avibactam | Best Available Treatment |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 1/30 | 6/29 |
| CoagulopathyBlood and lymphatic system disorders | 2/30 | 3/29 |
| Cardiac failureCardiac disorders | 0/30 | 3/29 |
| ConstipationGastrointestinal disorders | 2/30 | 3/29 |
| VomitingGastrointestinal disorders | 0/30 | 3/29 |
| Hepatic function abnormalHepatobiliary disorders | 3/30 | 0/29 |
| HypokalaemiaMetabolism and nutrition disorders | 3/30 | 1/29 |
| Gastrointestinal haemorrhageGastrointestinal disorders | 2/30 | 2/29 |
| Acid base balance abnormalInvestigations | 0/30 | 2/29 |
| Blood creatinine increasedInvestigations | 0/30 | 2/29 |
Safety analysis set included all participants who took any study intervention. Participants were analyzed according to the product they actually received.
| Age, Customized(Participants) | Ceftazidime-Avibactam | Best Available Treatment | Total |
|---|---|---|---|
| 18-44 years | 1 | 2 | 3 |
| 45-64 years | 8 | 8 | 16 |
| Greater than equal to (>=) 65 years | 21 | 19 | 40 |
| Sex: Female, Male(Participants) | Ceftazidime-Avibactam | Best Available Treatment | Total |
|---|---|---|---|
| Female | 8 | 9 | 17 |
| Male | 22 | 20 | 42 |
| Race and Ethnicity Not Collected(Participants) | Ceftazidime-Avibactam | Best Available Treatment | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Data sharing details ↗ · www.pfizer.com
Ran from Aug 2021 to primary completion in Aug 2023, 24 months.
Results were first posted in Oct 2024, 1 year 1 month after primary completion.
Of 50 phase 4 interventional studies under Urinary Tract Infections, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 46. This study's 24 months is below that.
How these figures are worked out, and which studies are left out of them.
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