Clinical trial NCT03293485: 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)
Official title: A Phase III Non-randomized, Non-controlled, Open Label Clinical Trial to Study the Safety and Efficacy of Imipenem/Cilastatin/Relebactam (IMI/REL [MK-7655A]) in Japanese Subjects With Complicated Intra-Abdominal Infection (cIAI) or Complicated Urinary Tract Infection (cUTI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Complicated Intra-abdominal Infection
Complicated Urinary Tract Infection
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2017-09-26
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Percentage of Participants Experiencing ≥1 Adverse Events (AE)
timeFrame: Up to 28 days
measure: Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (AE)
timeFrame: Up to 14 days (End of Therapy Visit)
measure: Percentage of Complicated Intra-Abdominal Infection (cIAI) Participants With Favorable Clinical Response at End of Therapy Visit
timeFrame: Between Day 5 and Day 14 (End of Therapy Visit)
measure: Percentage of Complicated Urinary Tract Infection (cUTI) Participants With Favorable Overall Microbiological Response at End of Therapy Visit
timeFrame: Between Day 5 and Day 14 (End of Therapy Visit)
Secondary outcomes:
measure: Percentage of Complicated Intra-Abdominal Infection (cIAI) Participants With Favorable Clinical Response at Test of Cure Visit
timeFrame: Between Day 10 and Day 23 (Test of Cure Visit)
measure: Percentage of Complicated Urinary Tract Infection (cUTI) Participants With Favorable Overall Microbiological Response at Test of Cure Visit
timeFrame: Between Day 10 and Day 23 (Test of Cure Visit)
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Nagoya Ekisaikai Hospital ( Site 1724)
state: Aichi
city: Toyota
country: Japan
facility: Toyota Memorial Hospital ( Site 1708)
state: Aichi
city: Onga-gun
country: Japan
facility: Medical Corporation Chiyukai Fukuoka Shin Mizumaki Hospital ( Site 1710)
state: Fukuoka
city: Yukuhashi
country: Japan
facility: Shin Yukuhashi Hospital ( Site 1722)
state: Fukuoka
city: Fukuyama
country: Japan
facility: National Hospital Organization Fukuyama Medical Center ( Site 1706)
state: Hiroshima
city: Fukuyama
country: Japan
facility: Fukuyama City Hospital ( Site 1721)
state: Hiroshima
city: Sapporo
country: Japan
facility: KKR Sapporo Medical Center ( Site 1728)
state: Hokkaido
city: Kobe
country: Japan
facility: Sano Hospital ( Site 1701)
state: Hyogo
city: Higashiibaraki-gun
country: Japan
facility: National Hospital Organization Mito Medical Center ( Site 1729)
state: Ibaraki
city: Koga
country: Japan
facility: Medical Corporation Tokushukai Koga General Hospital ( Site 1712)
state: Ibaraki
city: Kanazawa
country: Japan
facility: Ishikawa Prefectural Central Hospital ( Site 1707)
state: Ishikawa
city: Kanazawa
country: Japan
facility: National Hospital Organization Kanazawa Medical Center ( Site 1716)
state: Ishikawa
city: Aira
country: Japan
facility: Kawahara Clinic ( Site 1719)
state: Kagoshima
city: Yokohama
country: Japan
facility: National Hospital Organization Yokohama Medical Center ( Site 1702)
state: Kanagawa
city: Tsu
country: Japan
facility: National Hospital Organization Mie Chuo Medical Center ( Site 1727)
state: Mie
city: Sendai
country: Japan
facility: Japan Labour Health And Safety Organization Tohoku Rosai Hospital ( Site 1714)
state: Miyagi
city: Sendai
country: Japan
facility: National Hospital Organization Sendai Medical Center ( Site 1723)
state: Miyagi
city: Suwa
country: Japan
facility: Suwa Red Cross Hospital ( Site 1705)
state: Nagano
city: Omura
country: Japan
facility: National Hospital Organization Nagasaki Medical Center ( Site 1718)
state: Nagasaki
city: Kawachinagano
country: Japan
facility: National Hospital Organization Osaka Minami Medical Center ( Site 1715)
state: Osaka
city: Utsunomiya
country: Japan
facility: National Hospital Organization Utsunomiya National Hospital ( Site 1711)
state: Tochigi
city: Tanabe
country: Japan
facility: National Hospital Organization Minami Wakayama Medical Center ( Site 1725)
state: Wakayama
city: Kofu
country: Japan
facility: Yamanashi Prefectural Central Hospital ( Site 1703)
state: Yamanashi
city: Fukui
country: Japan
facility: Fukuiken Saiseikai Hospital ( Site 1704)
city: Fukuoka
country: Japan
facility: Medical Corporation Chiyukai Fukuoka Wajiro Hospital ( Site 1709)
city: Kagoshima
country: Japan
facility: Medical Corporation Shingenkai Kawahara Urological Clinic ( Site 1726)
city: Kagoshima
country: Japan
facility: Medical Corporation Seifukai Yagi Clinic ( Site 1720)
city: Kumamoto
country: Japan
facility: National Hospital Organization Kumamoto Medical Center ( Site 1713)
city: Oita
country: Japan
facility: National Hospital Organization Oita Medical Center ( Site 1717)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.