Phase 3
N=60
Study to Assess Efficacy and Safety of PF-06947386 in Japanese Adult Patients With Complicated Intra-abdominal Infection
Complicated Intra-abdominal Infection
Bottom Line
View on ClinicalTrials.gov: NCT04927312 ↗Enrolled (actual)
60
Serious AEs
5.0%
Results posted
Mar 2024
Primary outcome: Primary: Number of Participants With Clinical Response at Test of Cure (TOC) Visit: Clinically Evaluable (CE) Analysis Set — 36; 4; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- PF-06947386 (Drug); Metronidazole (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinical Response at Test of Cure (TOC) Visit: Clinically Evaluable (CE) Analysis Set |
36; 4; 0 | — |
| SECONDARY Percentage of Participants With Clinical Response at End of Treatment (EOT) and Late Follow-up (LFU) Visits: CE Analysis Set |
90.5; 9.5; 0; 90.0; 10.0; 0 | — |
| SECONDARY Number of Participants With Clinical Response at EOT and LFU Visits: Modified Intent-to-Treat (MITT) Analysis Set |
54; 4; 1; 52; 4; 3 | — |
| SECONDARY Number of Participants With Clinical Response at EOT and LFU Visits: Microbiological Modified Intent-to-Treat (mMITT) Analysis Set |
38; 4; 0; 36; 4; 2 | — |
| SECONDARY Percentage of Participants With Clinical Response at EOT and LFU Visits: Microbiologically Evaluable (ME) Analysis Set |
94.4; 5.6; 0; 94.3; 5.7; 0 | — |
| SECONDARY Percentage of Participants With Clinical Response EOT and LFU Visits: Extended Microbiologically Evaluable (eME) Analysis Set |
94.6; 5.4; 0; 94.4; 5.6; 0 | — |
| SECONDARY Number of Participants With Microbiological Response EOT, TOC and LFU Visits: mMITT Analysis Set |
38; 4; 0; 36; 4; 2 | — |
| SECONDARY Percentage of Participants With Microbiological Response EOT, TOC and LFU Visits: ME Analysis Set |
94.4; 5.6; 0; 94.3; 5.7; 0 | — |
| SECONDARY Percentage of Participants With Microbiological Response EOT, TOC and LFU Visits: eME Analysis Set |
94.6; 5.4; 0; 94.4; 5.6; 0 | — |
| SECONDARY Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: mMITT Analysis Set |
100.0; 93.5; 100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: ME Analysis Set |
100.0; 93.5; 100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: eME Analysis Set |
100.0; 93.5; 100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Percentage of Participants With Favorable Per-Pathogen Microbiological Response by Minimum Inhibitory Concentration (MIC) Categories at EOT, TOC and LFU Visits: mMITT Analysis Set |
100.0; 93.3; 100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: ME Analysis Set |
100.0; 93.3; 100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: eME Analysis Set |
100.0; 93.3; 100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs (SAEs) |
42; 3 | — |
| SECONDARY All-cause Mortality |
1 | — |
| SECONDARY Number of Participants Who Discontinued Treatment and Study Due to Adverse Events |
0; 2 | — |
| SECONDARY Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) |
119.0; 3.8; 6.1; 8.0; 8.2; 2.2 | — |
| SECONDARY Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Pulse Rate |
82.6; -4.8; -7.1; -8.9; -11.3; -12.4 | — |
| SECONDARY Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Weight |
62.05; 0.64; 0.68; 0.34; 0.39; 0.82 | — |
| SECONDARY Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Temperature |
37.01; 0.33; 0.09; -0.05; -0.12; -0.29 | — |
| SECONDARY Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Respiratory Rate |
17.8; 0.4; -0.4; -1.1; -0.5; -1.3 | — |
| SECONDARY Number of Participants With Laboratory Test Abnormalities |
60 | — |
| SECONDARY Plasma Concentration of Avibactam |
13810; 8321; 1148; 13940; 7897; 1651 | — |
| SECONDARY Plasma Concentration of Ceftazidime |
72940; 48800; 10030; 76680; 49190; 13920 | — |
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.
Eligibility Criteria
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
- Participant is considered unlikely to survive the 6- to 8-week study period or has a rapidly progressive or terminal illness
- Participant is pregnant or breastfeeding.
- Participant has received systemic antibacterial agents within the 72-hour period prior to study entry except for cases specified in the protocol such that participant is considered to have failed the previous treatment regimen, or participant has received systemic antibiotic agents no more than 24 hours (no more than one daily dose) within the 72-hour period prior to study entry, etc.
- Estimated CrCL ≤50 mL/min calculated by Cockcroft-Gault method.
Data sourced from ClinicalTrials.gov (NCT04927312). 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.