Trials / Completed
CompletedNCT04927312
Study to Assess Efficacy and Safety of PF-06947386 in Japanese Adult Patients With Complicated Intra-abdominal Infection
A PHASE 3, MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY TO ASSESS THE EFFICACY AND SAFETY OF CEFTAZIDIME-AVIBACTAM (PF-06947386) PLUS METRONIDAZOLE IN JAPANESE ADULT PATIENTS WITH COMPLICATED INTRA-ABDOMINAL INFECTION REQUIRING HOSPITALIZATION
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PF-06947386 | 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. |
| DRUG | Metronidazole | Metronidazole 0.5 g solution for injection. |
Timeline
- Start date
- 2021-10-01
- Primary completion
- 2022-09-15
- Completion
- 2022-09-15
- First posted
- 2021-06-15
- Last updated
- 2024-03-13
- Results posted
- 2024-03-08
Locations
29 sites across 1 country: Japan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04927312. Inclusion in this directory is not an endorsement.