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PF-06947386 · 1 trial · 1 indication
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...
PF-06947386 is an investigational small molecule being developed for the treatment of complicated intra-abdominal infection, a serious bacterial infection within the abdominal cavity. It is being studied in adult patients with this condition.
PF-06947386 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE.
PF-06947386 is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 3 trial has been completed to assess its efficacy and safety.
PF-06947386 has been studied in one completed Phase 3 clinical trial, identified as NCT04927312. This trial assessed the efficacy and safety of PF-06947386 in Japanese adult patients with complicated intra-abdominal infection.
No alternative names for PF-06947386 have been reported. It is identified solely by its investigational code, PF-06947386.