Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04927312 | Study to Assess Efficacy and Safety of PF-06947386 in Japanese Adult Patients With Complicated Intra-abdominal Infection | PHASE3 | COMPLETED | 60 | — | — | Oct 1, 2021 | Sep 15, 2022 | Mar 13, 2024 | 29 | Japan |
Clinical response: Clinical response of cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within the abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptoms of intra-abdominal infection; Indeterminate: Study data was not available for evaluation of efficacy for any reason. TOC was after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.
| Arm | Type | Description |
|---|---|---|
| PF-06947386 + Metronidazole | EXPERIMENTAL | Multiple intravenous infusion of ceftazidime-avibactam followed by intravenous infusion of metronidazole, repeated every 8 hours for 5-14 days. |
| Name | Type | Description |
|---|---|---|
| PF-06947386 | DRUG | Ceftazidime-Avibactam powder for concentrate for solution for infusion 2.0 g/ 0.5 g. Dosage will be adjusted based on renal function after enrollment. |
| Metronidazole | DRUG | Metronidazole 0.5 g solution for injection. |
Inclusion Criteria: * Participant who is capable of giving signed, dated and timed informed consent (or by their legally acceptable representative) * Participant aged 20 years or older * Participant who is willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and o...