Efficacy and Safety of Imipenem+Cilastatin/Relebactam (MK-7655A) in Japanese Participants With Complicated Intra-abdominal Infection or Complicated Urinary Tract Infection (MK-7655A-017)

NCT ID: NCT03293485

Last Updated: 2021-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-04
• Study Completion Date: 2018-09-14

Brief Summary

The study will evaluate the efficacy and safety of imipenem+cilastatin/relebactam (IMI/REL, MK-7655A) in Japanese participants with complicated intra-abdominal infection (cIAI) or complicated urinary tract infection (cUTI).

Conditions

Complicated Intra-abdominal Infection; Complicated Urinary Tract Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Imipenem+Cilastatin/Relebactam

Participants with cIAI or cUTI will receive imipenem+cilastatin/relebactam intravenous (IV) infusion once every 6 hours for 5 to 14 days

Group Type: EXPERIMENTAL

Imipenem+Cilastatin/Relebactam

Intervention Type: DRUG

Imipenem+Cilastatin/Relebactam 200/100 mg to 500/250 mg, depending on renal function, 30-minute IV infusion once every 6 hours

Interventions

Imipenem+Cilastatin/Relebactam

Imipenem+Cilastatin/Relebactam 200/100 mg to 500/250 mg, depending on renal function, 30-minute IV infusion once every 6 hours

Intervention Type: DRUG

Other Intervention Names

IMI/REL; MK-7655A

Eligibility Criteria

Inclusion Criteria

• requires hospitalization and treatment with IV antibiotic therapy for complicated intraabdominal infection (cIAI) or complicated urinary tract infection (cUTI). Per-protocol diagnostic criteria apply to the qualifying infection types.
• infection is known or thought to be caused by microorganisms susceptible to the IV study therapy
• baseline specimen for primary infection site culture obtained at operative procedure in Screening period or at Baseline for cIAI participants, and within 48 hours before initiation of IV study drug for cUTI participants
• female or male who is not of reproductive potential, or female or male who is of reproductive potential and agrees to avoid becoming pregnant or impregnating a partner from the time of consent through completion of the study, by practicing abstinence from heterosexual activity or using acceptable contraception during heterosexual activity.

Exclusion Criteria

• received any amount of effective antibiotic therapy after obtaining the culture for admission to the study and before administration of the first dose of IV study therapy
• received treatment with systemic effective antibiotics for >24 hours within the 72 hours before initiation of study therapy
• has a concurrent infection, including endocarditis, osteomyelitis, meningitis, or prosthetic joint infection, that would interfere with evaluation of response to IMI/REL
• has a cIAI or cUTI due to a confirmed fungal pathogen
• has a cUTI that meets any of the following: 1) complete obstruction of any portion of the urinary tract, 2) known ileal loop, 3) intractable vesico-ureteral reflux, 4) presence of indwelling urinary catheter which cannot be removed at study entry
• has a cIAI that meets any of the following: 1) infection that should be managed by Staged Abdominal Repair (STAR) or open abdomen therapy, 2) infection limited to the hollow viscus
• history of serious allergy, hypersensitivity, or any serious reaction to any carbapenem, cephalosporin, penicillin or other beta-lactam agent, or other beta-lactamase inhibitors
• female who is pregnant or is expecting to conceive, is breastfeeding, or plans to breastfeed before completion of the study
• history of a seizure disorder
• anticipates to be treated with valproic acid, concomitant IV or an oral antimicrobial considered effective to the index pathogen, in addition to the study treatment
• is receiving immunosuppressive therapy, including high-dose corticosteroids
• is undergoing hemodialysis or peritoneal dialysis
• participated in any other clinical study involving an investigational or experimental medication during the previous 30 days before Screening.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

Nagoya Ekisaikai Hospital ( Site 1724)

Nagoya, Aichi-ken, Japan

Toyota Memorial Hospital ( Site 1708)

Toyota, Aichi-ken, Japan

Medical Corporation Chiyukai Fukuoka Shin Mizumaki Hospital ( Site 1710)

Onga-gun, Fukuoka, Japan

Shin Yukuhashi Hospital ( Site 1722)

Yukuhashi, Fukuoka, Japan

National Hospital Organization Fukuyama Medical Center ( Site 1706)

Fukuyama, Hiroshima, Japan

Fukuyama City Hospital ( Site 1721)

Fukuyama, Hiroshima, Japan

KKR Sapporo Medical Center ( Site 1728)

Sapporo, Hokkaido, Japan

Sano Hospital ( Site 1701)

Kobe, Hyōgo, Japan

National Hospital Organization Mito Medical Center ( Site 1729)

Higashiibaraki-gun, Ibaraki, Japan

Medical Corporation Tokushukai Koga General Hospital ( Site 1712)

Koga, Ibaraki, Japan

Ishikawa Prefectural Central Hospital ( Site 1707)

Kanazawa, Ishikawa-ken, Japan

National Hospital Organization Kanazawa Medical Center ( Site 1716)

Kanazawa, Ishikawa-ken, Japan

Kawahara Clinic ( Site 1719)

Aira, Kagoshima-ken, Japan

National Hospital Organization Yokohama Medical Center ( Site 1702)

Yokohama, Kanagawa, Japan

National Hospital Organization Mie Chuo Medical Center ( Site 1727)

Tsu, Mie-ken, Japan

Japan Labour Health And Safety Organization Tohoku Rosai Hospital ( Site 1714)

Sendai, Miyagi, Japan

National Hospital Organization Sendai Medical Center ( Site 1723)

Sendai, Miyagi, Japan

Suwa Red Cross Hospital ( Site 1705)

Suwa, Nagano, Japan

National Hospital Organization Nagasaki Medical Center ( Site 1718)

Ōmura, Nagasaki, Japan

National Hospital Organization Osaka Minami Medical Center ( Site 1715)

Kawachi-Nagano, Osaka, Japan

National Hospital Organization Utsunomiya National Hospital ( Site 1711)

Utsunomiya, Tochigi, Japan

National Hospital Organization Minami Wakayama Medical Center ( Site 1725)

Tanabe, Wakayama, Japan

Yamanashi Prefectural Central Hospital ( Site 1703)

Kofu, Yamanashi, Japan

Fukuiken Saiseikai Hospital ( Site 1704)

Fukui, , Japan

Medical Corporation Chiyukai Fukuoka Wajiro Hospital ( Site 1709)

Fukuoka, , Japan

Medical Corporation Shingenkai Kawahara Urological Clinic ( Site 1726)

Kagoshima, , Japan

Medical Corporation Seifukai Yagi Clinic ( Site 1720)

Kagoshima, , Japan

National Hospital Organization Kumamoto Medical Center ( Site 1713)

Kumamoto, , Japan

National Hospital Organization Oita Medical Center ( Site 1717)

Ōita, , Japan

Countries

Japan

References

Kohno S, Bando H, Yoneyama F, Kikukawa H, Kawahara K, Shirakawa M, Aoyama N, Brown M, Paschke A, Takase A. The safety and efficacy of relebactam/imipenem/cilastatin in Japanese patients with complicated intra-abdominal infection or complicated urinary tract infection: A multicenter, open-label, noncomparative phase 3 study. J Infect Chemother. 2021 Feb;27(2):262-270. doi: 10.1016/j.jiac.2020.09.032. Epub 2020 Nov 13.

Reference Type: RESULT

PMID: 33191112 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

173738

Identifier Type: REGISTRY

Identifier Source: secondary_id

7655A-017

Identifier Type: -

Identifier Source: org_study_id