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| ID | Type | Description | Link |
|---|---|---|---|
| 173738 | Registry Identifier | JAPIC-CTI |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imipenem+Cilastatin/Relebactam | Experimental | Participants with cIAI or cUTI will receive imipenem+cilastatin/relebactam intravenous (IV) infusion once every 6 hours for 5 to 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imipenem+Cilastatin/Relebactam | Drug | Imipenem+Cilastatin/Relebactam 200/100 mg to 500/250 mg, depending on renal function, 30-minute IV infusion once every 6 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Experiencing ≥1 Adverse Events (AE) | The percentage of participants experiencing ≥1 AE was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined. | Up to 28 days |
| Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (AE) | The percentage of participants who discontinued from study medication due to an adverse event was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined. | Up to 14 days (End of Therapy Visit) |
| Percentage of Complicated Intra-Abdominal Infection (cIAI) Participants With Favorable Clinical Response at End of Therapy Visit | The percentage of participants with cIAI who display a favorable clinical response at End of Therapy visit was presented. Per protocol, a subset of the cIAI/cUTI study arm was analyzed: only participants with cIAI were evaluated because clinical response is primarily relevant to cIAI. Favorable clinical response is a rating of "cure" or "improved" as determined by the investigator at the End of Therapy Visit. "Cure" is defined as: all pretherapy signs and symptoms of the index infection(s) have resolved (or returned to preinfection status) AND no additional intravenous antibiotic therapy is required AND no unplanned surgical or percutaneous drainage procedures have been performed. "Improved" is defined as: All or most pretherapy signs and symptoms of the index infection(s) have improved or resolved (or returned to preinfection status) AND no additional intravenous antibiotic therapy is required AND no unplanned surgical or percutaneous drainage procedures have been performed. | Between Day 5 and Day 14 (End of Therapy Visit) |
| Percentage of Complicated Urinary Tract Infection (cUTI) Participants With Favorable Overall Microbiological Response at End of Therapy Visit |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Complicated Intra-Abdominal Infection (cIAI) Participants With Favorable Clinical Response at Test of Cure Visit | The percentage of participants with cIAI who display a favorable Clinical Response at the Test of Cure visit was calculated. Per protocol, only a subset of the cIAI/cUTI study arm was analyzed: only participants with cIAI were evaluated because the clinical response evaluation is primarily relevant to cIAI. A favorable clinical response is a rating of "cure" as determined by the investigator at the Test of Cure Visit. "Cure" is defined as: all pretherapy signs and symptoms of the index infection(s) have resolved (or returned to "preinfection status") AND no additional intravenous antibiotic therapy is required AND no unplanned surgical or percutaneous drainage procedures have been performed. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya Ekisaikai Hospital ( Site 1724) | Nagoya | Aichi-ken | 454-8502 | Japan | ||
| Toyota Memorial Hospital ( Site 1708) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33191112 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | cIAI/cUTI | Participants with complicated intra-abdominal infection (cIAI) or complicated urinary tract infection (cUTI) received intravenous imipenem+cilastatin+relebactam (IMI/REL) once every 6 hours for 5-14 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 18, 2017 |
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The percentage of participants with cUTI who display a favorable Overall Microbiological Response at the End of Therapy visit was calculated. Per protocol, only a subset of the cIAI/cUTI study arm was analyzed: only participants with cUTI were evaluated because the microbiological response evaluation is primarily relevant to cUTI. A favorable Overall Microbiological Response is defined as a urine culture taken at the End of Therapy Visit showing eradication (e.g., ≥10^5 CFU/mL is reduced to <10^4 CFU/mL) of all uropathogens found at study entry. |
| Between Day 5 and Day 14 (End of Therapy Visit) |
| Between Day 10 and Day 23 (Test of Cure Visit) |
| Percentage of Complicated Urinary Tract Infection (cUTI) Participants With Favorable Overall Microbiological Response at Test of Cure Visit | The percentage of participants with cUTI who display a favorable Overall Microbiological Response at the Test of Cure visit was calculated. Per protocol, only a subset of the cIAI/cUTI study arm was analyzed: only participants with cUTI were evaluated because the microbiological response evaluation is primarily relevant to cUTI. A favorable Overall Microbiological Response is defined as a urine culture taken at the Test of Cure visit still showing eradication (e.g., ≥10^5 CFU/mL is reduced to <10^4 CFU/mL) of all uropathogens found at study entry. | Between Day 10 and Day 23 (Test of Cure Visit) |
| Toyota |
| Aichi-ken |
| 471-8513 |
| Japan |
| Medical Corporation Chiyukai Fukuoka Shin Mizumaki Hospital ( Site 1710) | Onga-gun | Fukuoka | 807-0051 | Japan |
| Shin Yukuhashi Hospital ( Site 1722) | Yukuhashi | Fukuoka | 824-0026 | Japan |
| National Hospital Organization Fukuyama Medical Center ( Site 1706) | Fukuyama | Hiroshima | 720-8520 | Japan |
| Fukuyama City Hospital ( Site 1721) | Fukuyama | Hiroshima | 721-8511 | Japan |
| KKR Sapporo Medical Center ( Site 1728) | Sapporo | Hokkaido | 062-0931 | Japan |
| Sano Hospital ( Site 1701) | Kobe | Hyōgo | 655-0031 | Japan |
| National Hospital Organization Mito Medical Center ( Site 1729) | Higashiibaraki-gun | Ibaraki | 311-3193 | Japan |
| Medical Corporation Tokushukai Koga General Hospital ( Site 1712) | Koga | Ibaraki | 306-0041 | Japan |
| Ishikawa Prefectural Central Hospital ( Site 1707) | Kanazawa | Ishikawa-ken | 920-8530 | Japan |
| National Hospital Organization Kanazawa Medical Center ( Site 1716) | Kanazawa | Ishikawa-ken | 920-8650 | Japan |
| Kawahara Clinic ( Site 1719) | Aira | Kagoshima-ken | 899-5431 | Japan |
| National Hospital Organization Yokohama Medical Center ( Site 1702) | Yokohama | Kanagawa | 245-8575 | Japan |
| National Hospital Organization Mie Chuo Medical Center ( Site 1727) | Tsu | Mie-ken | 514-1101 | Japan |
| Japan Labour Health And Safety Organization Tohoku Rosai Hospital ( Site 1714) | Sendai | Miyagi | 981-8563 | Japan |
| National Hospital Organization Sendai Medical Center ( Site 1723) | Sendai | Miyagi | 983-8520 | Japan |
| Suwa Red Cross Hospital ( Site 1705) | Suwa | Nagano | 392-8510 | Japan |
| National Hospital Organization Nagasaki Medical Center ( Site 1718) | Ōmura | Nagasaki | 856-8562 | Japan |
| National Hospital Organization Osaka Minami Medical Center ( Site 1715) | Kawachi-Nagano | Osaka | 586-8521 | Japan |
| National Hospital Organization Utsunomiya National Hospital ( Site 1711) | Utsunomiya | Tochigi | 329-1193 | Japan |
| National Hospital Organization Minami Wakayama Medical Center ( Site 1725) | Tanabe | Wakayama | 646-8558 | Japan |
| Yamanashi Prefectural Central Hospital ( Site 1703) | Kofu | Yamanashi | 400-8506 | Japan |
| Fukuiken Saiseikai Hospital ( Site 1704) | Fukui | 918-8503 | Japan |
| Medical Corporation Chiyukai Fukuoka Wajiro Hospital ( Site 1709) | Fukuoka | 811-0213 | Japan |
| Medical Corporation Shingenkai Kawahara Urological Clinic ( Site 1726) | Kagoshima | 890-0073 | Japan |
| Medical Corporation Seifukai Yagi Clinic ( Site 1720) | Kagoshima | 891-0105 | Japan |
| National Hospital Organization Kumamoto Medical Center ( Site 1713) | Kumamoto | 860-0008 | Japan |
| National Hospital Organization Oita Medical Center ( Site 1717) | Ōita | 870-0263 | Japan |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | cIAI/cUTI | Participants with cIAI or cUTI received intravenous imipenem+cilastatin+relebactam once every 6 hours for 5-14 days. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Infection Type | Participants enrolled with either complicated intra-abdominal infection (cIAI), or complicated urinary tract infection (cUTI). | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Experiencing ≥1 Adverse Events (AE) | The percentage of participants experiencing ≥1 AE was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined. | Per protocol, the population analyzed was all participants who received ≥1 dose of intravenous imipenem+cilastatin+relebactam. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 28 days |
|
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| |||||||||||||||||||||||||
| Primary | Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (AE) | The percentage of participants who discontinued from study medication due to an adverse event was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined. | Per protocol, the population analyzed was all participants who received ≥1 dose of intravenous imipenem+cilastatin+relebactam. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 14 days (End of Therapy Visit) |
|
| ||||||||||||||||||||||||||
| Primary | Percentage of Complicated Intra-Abdominal Infection (cIAI) Participants With Favorable Clinical Response at End of Therapy Visit | The percentage of participants with cIAI who display a favorable clinical response at End of Therapy visit was presented. Per protocol, a subset of the cIAI/cUTI study arm was analyzed: only participants with cIAI were evaluated because clinical response is primarily relevant to cIAI. Favorable clinical response is a rating of "cure" or "improved" as determined by the investigator at the End of Therapy Visit. "Cure" is defined as: all pretherapy signs and symptoms of the index infection(s) have resolved (or returned to preinfection status) AND no additional intravenous antibiotic therapy is required AND no unplanned surgical or percutaneous drainage procedures have been performed. "Improved" is defined as: All or most pretherapy signs and symptoms of the index infection(s) have improved or resolved (or returned to preinfection status) AND no additional intravenous antibiotic therapy is required AND no unplanned surgical or percutaneous drainage procedures have been performed. | Per protocol, the population analyzed was all participants with cIAI who received intravenous imipenem+cilastatin+relebactam ≥96 hours, whose pre-study infection-site culture grew ≥1 gram-negative enteric and/or anaerobic pathogen, and who had no major deviations from the protocol that may substantially affect the results of the efficacy analyses. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Between Day 5 and Day 14 (End of Therapy Visit) |
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| Primary | Percentage of Complicated Urinary Tract Infection (cUTI) Participants With Favorable Overall Microbiological Response at End of Therapy Visit | The percentage of participants with cUTI who display a favorable Overall Microbiological Response at the End of Therapy visit was calculated. Per protocol, only a subset of the cIAI/cUTI study arm was analyzed: only participants with cUTI were evaluated because the microbiological response evaluation is primarily relevant to cUTI. A favorable Overall Microbiological Response is defined as a urine culture taken at the End of Therapy Visit showing eradication (e.g., ≥10^5 CFU/mL is reduced to <10^4 CFU/mL) of all uropathogens found at study entry. | Per protocol, the population analyzed was all participants with cUTI who received intravenous imipenem+cilastatin+relebactam ≥96 hours, whose pre-study infection-site culture grew ≥1 gram-negative and/or anaerobic pathogen, and who had no major deviations from the protocol that may substantially affect the results of the efficacy analyses. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Between Day 5 and Day 14 (End of Therapy Visit) |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Complicated Intra-Abdominal Infection (cIAI) Participants With Favorable Clinical Response at Test of Cure Visit | The percentage of participants with cIAI who display a favorable Clinical Response at the Test of Cure visit was calculated. Per protocol, only a subset of the cIAI/cUTI study arm was analyzed: only participants with cIAI were evaluated because the clinical response evaluation is primarily relevant to cIAI. A favorable clinical response is a rating of "cure" as determined by the investigator at the Test of Cure Visit. "Cure" is defined as: all pretherapy signs and symptoms of the index infection(s) have resolved (or returned to "preinfection status") AND no additional intravenous antibiotic therapy is required AND no unplanned surgical or percutaneous drainage procedures have been performed. | Per protocol, the population analyzed was all participants with cIAI who received intravenous imipenem+cilastatin+relebactam ≥96 hours, whose pre-study infection-site culture grew ≥1 gram-negative enteric and/or anaerobic pathogen, and who had no major deviations from the protocol that may substantially affect the results of the efficacy analyses. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Between Day 10 and Day 23 (Test of Cure Visit) |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Complicated Urinary Tract Infection (cUTI) Participants With Favorable Overall Microbiological Response at Test of Cure Visit | The percentage of participants with cUTI who display a favorable Overall Microbiological Response at the Test of Cure visit was calculated. Per protocol, only a subset of the cIAI/cUTI study arm was analyzed: only participants with cUTI were evaluated because the microbiological response evaluation is primarily relevant to cUTI. A favorable Overall Microbiological Response is defined as a urine culture taken at the Test of Cure visit still showing eradication (e.g., ≥10^5 CFU/mL is reduced to <10^4 CFU/mL) of all uropathogens found at study entry. | Per protocol, the population analyzed was all participants with cUTI who received intravenous imipenem+cilastatin+relebactam ≥96 hours, whose pre-study infection-site culture grew ≥1 gram-negative and/or anaerobic pathogen, and who had no major deviations from the protocol that may substantially affect the results of the efficacy analyses. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Between Day 10 and Day 23 (Test of Cure Visit) |
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Up to 28 days (up to 14 days after completion of intravenous study therapy)
Adverse events were reported for all participants who received at least one dose of IV study therapy.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | cIAI/cUTI | Participants with cIAI or cUTI received intravenous imipenem+cilastatin+relebactam once every 6 hours for 5-14 days. | 1 | 81 | 9 | 81 | 18 | 81 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rhegmatogenous retinal detachment | Eye disorders | MedDRA 21.1 | Systematic Assessment |
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| Large intestine perforation | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Pancreatitis acute | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA 21.1 | Systematic Assessment |
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| Abdominal abscess | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Pelvic abscess | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Peritonitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
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| Renal haematoma | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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Subsequent to the multicenter publication (or after public disclosure of the results at www.clinicaltrials.gov if multicenter manuscript is not planned), an investigator and colleagues may publish their data independently.
Sponsor must have opportunity to review proposed abstracts, manuscripts or presentations 45 days prior to submission for publication/presentation. Confidential information must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| Aug 23, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| C000633884 | imipenem, cilastatin and relebactam |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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