Phase 3
N=441
Compare Ceftazidime-Avibactam + Metronidazole vs Meropenem for Hospitalized Adults With Complicated Intra-Abd Infections
Complicated Intra-abdominal Infection
Bottom Line
View on ClinicalTrials.gov: NCT01726023 ↗Enrolled (actual)
441
Serious AEs
4.6%
Results posted
Apr 2016
Primary outcome: 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 Number of patients — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ceftazidime-avibactam (Drug); metronidazole (Drug); Meropenem (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2015
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 | — |
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.
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). 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.