Study to Assess Efficacy and Safety of PF-06947386 in Japanese Adult Patients With Complicated In… (NCT04927312) | Clinical Trial Compass
CompletedPhase 3
Study to Assess Efficacy and Safety of PF-06947386 in Japanese Adult Patients With Complicated Intra-abdominal Infection
Japan60 participantsStarted 2021-10-01
Plain-language summary
Study C3591036 is a Phase 3 study to assess the efficacy and safety of PF-06947386 in Japanese adult patients with complicated intra-abdominal infection requiring hospitalization. This is a multicenter, open-label, single-arm study. All eligible participants will receive intravenous infusion of PF-06947386 followed by intravenous infusion of metronidazole.
Who can participate
Age range20 Years
SexALL
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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 other study procedures
* Confirmation of infection by surgical intervention within 24 hours of entry: evidence of systemic inflammatory response; physical findings consistent with intra-abdominal infection; supportive radiologic imaging findings of intra-abdominal infections
* Intraoperative/postoperative enrollment with visual confirmation (presence of pus within the abdominal cavity) of an intra-abdominal infection associated with peritonitis
Exclusion Criteria:
* Participant will undergo surgery for traumatic bowel perforation within 12 hours or perforation of gastroduodenal ulcers within 24 hours. Other intra-abdominal processes that are not infectious.
* Participant has abdominal wall abscess or bowel obstruction without perforation or ischemic bowel without perforation
* Participant whose surgery will include staged abdominal repair, or "open abdomen" technique, or marsupialization.
* Participant has evidence of sepsis with shock not responding to IV fluid challenge or anticipated to require the administration of vasopressors for \>24 hours
* Participant has suspected intra-abdominal infections due to fungus, parasites (eg, amebic liver abscess), virus, or tuberculosis
* Par…
What they're measuring
1
Number of Participants With Clinical Response at Test of Cure (TOC) Visit: Clinically Evaluable (CE) Analysis Set