Study to Assess Efficacy and Safety of PF-06947386 in Japanese Adult Patients With Complicated Intra-abdominal Infection

NCT04927312 | Completed Phase 3 Results FDA Drug

• 1 other identifier: C3591036
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 29

Brief 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

Complicated Intra-abdominal Infection

Keywords

Ceftazidime-avibactam,; Metronidazole,; complicated intra-abdominal infection

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Clinical Response at Test of Cure (TOC) Visit: Clinically Evaluable (CE) Analysis Set

  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.

  TOC: Any day from Day 28 to Day 35

Secondary Outcomes (25)

• Percentage of Participants With Clinical Response at End of Treatment (EOT) and Late Follow-up (LFU) Visits: CE Analysis Set

  EOT: 24 hours after last IV infusion; LFU: Any day from Day 42 to Day 49

• Number of Participants With Clinical Response at EOT and LFU Visits: Modified Intent-to-Treat (MITT) Analysis Set

  EOT: 24 hours after last IV infusion; LFU: Any day from Day 42 to Day 49

• Number of Participants With Clinical Response at EOT and LFU Visits: Microbiological Modified Intent-to-Treat (mMITT) Analysis Set

  EOT: 24 hours after last IV infusion; LFU: Any day from Day 42 to Day 49

• Percentage of Participants With Clinical Response at EOT and LFU Visits: Microbiologically Evaluable (ME) Analysis Set

  EOT: 24 hours after last IV infusion; LFU: Any day from Day 42 to Day 49

• Percentage of Participants With Clinical Response EOT and LFU Visits: Extended Microbiologically Evaluable (eME) Analysis Set

  EOT: 24 hours after last IV infusion; LFU: Any day from Day 42 to Day 49

Other Outcomes (14)

• Number of Participants With Clinical Response at TOC Visit: MITT Analysis Set

  TOC: Any day from Day 28 to Day 35

• Number of Participants With Clinical Response at TOC Visit: mMITT Analysis Set

  TOC: Any day from Day 28 to Day 35

• Number of Participants With Clinical Response at TOC: ME Analysis Set

  TOC: Any day from Day 28 to Day 35

Study Arms (1)

PF-06947386 + Metronidazole

EXPERIMENTAL

Multiple intravenous infusion of ceftazidime-avibactam followed by intravenous infusion of metronidazole, repeated every 8 hours for 5-14 days.

Drug: PF-06947386; Drug: Metronidazole

Interventions

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.

PF-06947386 + Metronidazole

Metronidazole DRUG

Metronidazole 0.5 g solution for injection.

PF-06947386 + Metronidazole

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (29)

Nagoya Ekisaikai Hospital

Nagoya, Aichi-ken, 454-8502, Japan

Location

National Hospital Organization Nagoya Medical Center

Nagoya, Aichi-ken, 460-0001, Japan

Location

National Hospital Organization Toyohashi Medical Center

Toyohashi, Aichi-ken, 440-8510, Japan

Location

Fukuoka Tokushukai Hospital

Kasuga, Fukuoka, 816-0864, Japan

Location

St.Mary's Hospital

Kurume, Fukuoka, 830-8543, Japan

Location

Gunma Saiseikai Maebashi Hospital

Maebashi, Gunma, 371-0821, Japan

Location

Saiseikai Maebashi Hospital

Maebashi, Gunma, 371-0821, Japan

Location

Teine Keijinkai Hospital

Sapporo, Hokkaido, 006-8555, Japan

Location

Tsuchiura Kyodo General Hospital

Tsuchiura, Ibaraki, 300-0028, Japan

Location

Tsuchiura Kyodo General Hospital

Tsuchiura-shi, Ibaraki, 300-0028, Japan

Location

National Hospital Organization Kanazawa Medical Center

Kanazawa, Ishikawa-ken, 920-8650, Japan

Location

Kawasaki Saiwai Hospital

Kawasaki-shi, Kanagawa, 212-0014, Japan

Location

Sagamihara Kyodo Hospital

Sagamihara, Kanagawa, 252-5188, Japan

Location

National Hospital Organization Yokohama Medical Center

Yokohama, Kanagawa, 245-8575, Japan

Location

Suwa Red Cross Hospital

Suwa, Nagano, 392-8510, Japan

Location

National Hospital Organization Nagasaki Medical Center

Ōmura, Nagasaki, 856-8562, Japan

Location

Nagaoka Chuo General Hospital

Nagaoka, Niigata, 940-8653, Japan

Location

Naha City Hospital

Naha, Okinawa, 902-8511, Japan

Location

Rinku General Medical Center

Izumisano, Osaka, 598-8577, Japan

Location

National Hospital Organization Osaka Minami Medical Center

Kawachi-Nagano, Osaka, 586-8521, Japan

Location

Yamanashi Prefectural Central Hospital

Kofu, Yamanashi, 400-8506, Japan

Location

National Hospital Organization Chiba Medical Center

Chiba, 260-8606, Japan

Location

Fukuoka Wajiro Hospital

Fukuoka, 811-0213, Japan

Location

National Hospital Organization Kumamoto Medical Center

Kumamoto, 860-0008, Japan

Location

National Hospital Organization Kyoto Medical Center

Kyoto, 612-8555, Japan

Location

Okayama City General Medical Center Okayama City Hospital

Okayama, 700-8557, Japan

Location

Osaka Saiseikai Nakatsu Hospital

Osaka, 530-0012, Japan

Location

Toyama University Hospital

Toyama, 930-0194, Japan

Location

Yamagata City Hospital Saiseikan

Yamagata, 990-8533, Japan

Location

Related Publications (1)

• Mikamo H, Nakazuru Y, Tabuchi R, Suzuki M, Nagashima M, Tawadrous M, Wible M, Ohta M. Efficacy and safety of ceftazidime-avibactam in combination with metronidazole in Japanese patients with complicated intra-abdominal infection: A phase 3, multicentre, open-label study. J Infect Chemother. 2025 Mar;31(3):102598. doi: 10.1016/j.jiac.2024.102598. Epub 2024 Dec 21.

  PMID: 39710167 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Metronidazole

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 15, 2021
• Study Start: October 1, 2021
• Primary Completion: September 15, 2022
• Study Completion: September 15, 2022
• Last Updated: March 13, 2024
• Results First Posted: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share

Locations

JP (29)