Phase 3
Completed N=441
Compare Ceftazidime-Avibactam + Metronidazole vs Meropenem for Hospitalized Adults With Complicated Intra-Abd Infections
Source: ClinicalTrials.gov NCT01726023 ↗Enrolled (actual)
441
Serious AEs
4.6%
Results posted
Apr 2016
Primary outcomePrimary: The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Clinically Evaluable (CE) Analysis Set. — 166; 173; 11; 11 Number of patients — p=<0.001
◆ Published Evidence
Highly cited
100citations · ~14 / year
Ceftazidime-Avibactam Population Pharmacokinetic Modeling and Pharmacodynamic Target Attainment Across Adult Indications and Patient Subgroups.
Summary
The purpose of this study is to evaluate the effects of Ceftazidime Avibactam plus Metronidazole compared to Meropenem for treating hospitalized patients with complicated intra-abdominal infections.
Linked Publications (5)
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Ceftazidime-Avibactam Population Pharmacokinetic Modeling and Pharmacodynamic Target Attainment Across Adult Indications and Patient Subgroups.
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Clinical activity of ceftazidime/avibactam against MDR Enterobacteriaceae and Pseudomonas aeruginosa: pooled data from the ceftazidime/avibactam Phase III clinical trial programme.
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Ceftazidime-Avibactam Susceptibility Breakpoints against Enterobacteriaceae and Pseudomonas aeruginosa.
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Safety Profile of Ceftazidime-Avibactam: Pooled Data from the Adult Phase II and Phase III Clinical Trial Programme.
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Efficacy and safety of ceftazidime/avibactam in patients with infections caused by β-lactamase-producing Gram-negative pathogens: a pooled analysis from the Phase 3 clinical trial programme.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Clinically Evaluable (CE) Analysis Set. |
166; 173; 11; 11 | <0.001 sig |
| SECONDARY The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set. |
103; 113; 3; 5 | — |
| SECONDARY The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set. |
92; 107; 7; 6 | — |
| SECONDARY The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set. |
89; 100; 7; 6 | — |
| SECONDARY The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. |
104; 120; 3; 5 | — |
| SECONDARY The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. |
93; 113; 7; 6 | — |
| SECONDARY The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. |
90; 106; 7; 6 | — |
| SECONDARY The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. |
126; 140; 6; 7; 11; 5 | — |
| SECONDARY The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. |
119; 135; 10; 9; 14; 8 | — |
| SECONDARY The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. |
116; 132; 10; 9; 17; 11 | — |
| SECONDARY The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Clinically Evaluable (CE) Analysis Set. |
183; 187; 7; 9 | — |
| SECONDARY The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Clinically Evaluable (CE) Analysis Set. |
157; 168; 11; 11 | — |
| SECONDARY The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set. |
103; 113; 3; 5 | — |
| SECONDARY The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set. |
92; 107; 7; 6 | — |
| SECONDARY The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set. |
89; 100; 7; 6 | — |
| SECONDARY The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. |
104; 120; 3; 5 | — |
| SECONDARY The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. |
93; 113; 7; 6 | — |
| SECONDARY The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. |
90; 106; 7; 6 | — |
| SECONDARY The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. |
126; 140; 6; 7; 11; 5 | — |
| SECONDARY The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. |
119; 135; 10; 9; 14; 8 | — |
| SECONDARY The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. |
116; 132; 10; 9; 17; 11 | — |
| SECONDARY The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. |
77; 86; 5; 5; 22; 32 | — |
| SECONDARY The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. |
70; 84; 5; 5; 23; 31 | — |
| SECONDARY The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. |
70; 82; 22; 31; 14; 17 | — |
| SECONDARY The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set. |
68; 75; 5; 5; 21; 28 | — |
| SECONDARY The Proportion of Favorable Per-pathogen Microbiological Response at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set. |
64; 74; 5; 5; 21; 28 | — |
| SECONDARY The Proportion of Favorable Per-pathogen Microbiological Response at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set. |
63; 72; 4; 5; 21; 27 | — |
| SECONDARY The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. |
69; 78; 5; 5; 21; 29 | — |
| SECONDARY The Proportion of Favorable Per-pathogen Microbiological Response at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable(ME) Analysis Set. |
65; 77; 5; 5; 21; 29 | — |
| SECONDARY The Proportion of Favorable Per-pathogen Microbiological Response at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. |
64; 75; 4; 5; 21; 28 | — |
| SECONDARY The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. |
24; 27; 1; 1; 4; 1 | — |
| SECONDARY The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Microbiologically Evaluable (ME) Analysis Set. |
22; 23; 1; 1 | — |
| SECONDARY The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Extended Microbiologically Evaluable (ME) Analysis Set. |
22; 25; 1; 1 | — |
| SECONDARY The Time to First Defervescence in the Clinically Evaluable (CE) Analysis Set for Patients Who Have Fever at Study Entry. |
1; 1.5 | 0.773 |
| SECONDARY The Time to First Defervescence in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set for Patients Who Have Fever at Study Entry. |
1; 2 | 0.598 |
| SECONDARY Safety and Tolerability by Incidence and Severity of Adverse Events and Serious Adverse Events and Mortality. |
82; 83; 9; 11; 7; 3 | — |
| SECONDARY Safety and Tolerability by Incidence: Extent of Exposure. |
10; 5; 6; 5; 175; 181 | — |
| SECONDARY Safety and Tolerability: Clinical Laboratory Evaluation Hematology. |
1; 1; 5; 4; 7; 13 | — |
| SECONDARY Safety and Tolerability: Clinical Laboratory Evaluation Clinical Chemistry. |
3; 8; 0; 0; 2; 3 | — |
| SECONDARY Safety and Tolerability:ECG , QTcB and QTcF Intervals |
17; 14; 34; 30; 9; 10 | — |
| SECONDARY Plasma Concentrations for Ceftazidime and Avibactam |
60300.4; 10126.9; 46473.9; 7289.3; 9555.0; 1207.2 | — |
Eligibility Criteria
Inclusion Criteria
- Patient must be 18 to 90 years of age, inclusive,
- Female patients can participate if they are surgically sterilized or postmenopausal for at least 1 year or her sexual partner has had a vasectomy
- Female of childbearing potential has had normal menstrual periods for 3 months and negative serum pregnancy test and agree to practice highly effective methods of birth control during treatment and for at least 7 days after last dose
- Intraoperative/postoperative enrollment with visual confirmation (presence of pus within the abdominal cavity) of an intra-abdominal infection associated with peritonitis
- Confirmation of infection by surgical intervention within 24 hours of entry: evidence of systemic inflammatory indicators; physical findings consistent with intra-abdominal infection; supportive radiologic imaging findings of intra-abdominal infections
Exclusion Criteria
- Patient is diagnosed with traumatic bowel perforation undergoing surgery within 12 hours; perforation of gastroduodenal ulcers undergoing surgery within 24 hours. Other intra-abdominal processes in which primary etiology is not likely to be infectious
- Patient has abdominal wall abscess or bowel obstruction without perforation or ischemic bowel without perforation
- Patients whose surgery will include staged abdominal repair, or "open abdomen" technique, or marsupialization
- Patient has suspected intra-abdominal infections due to fungus, parasites, virus or tuberculosis
- Patient is considered unlikely to survive the 6- to 8-week study period or has a rapidly progressive or terminal illness, including septic shock that is associated with a high risk of mortality
Data sourced from ClinicalTrials.gov (NCT01726023) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.