A Phase 3 interventional study of Imipenem+Cilastatin/Relebactam in Complicated Intra-abdominal Infection and Complicated Urinary Tract Infection, sponsored by Merck Sharp & Dohme LLC. Completed at 29 sites in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-12.
Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Treatment
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).
Exclusion Criteria:
Participants with cIAI or cUTI will receive imipenem+cilastatin/relebactam intravenous (IV) infusion once every 6 hours for 5 to 14 days
Drug: 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
Also known as: IMI/REL, MK-7655A
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
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.
Time frame: Between Day 5 and Day 14 (End of Therapy Visit)
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.
Time frame: 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.
Time frame: Between Day 10 and Day 23 (Test of Cure Visit)
| Milestone | cIAI/cUTI |
|---|---|
| Started | 83 |
| Treated | 81 |
| Completed | 78 |
| Not completed | 5 |
| Withdrew: Death | 1 |
| Withdrew: Screen failure | 2 |
| Withdrew: Withdrawal by subject | 2 |
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.
| Percentage of Participants | cIAI/cUTI |
|---|---|
| Percentage of Participants Experiencing ≥1 Adverse Events (AE) | 74.1 (63.5 to 82.4) |
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.
| Percentage of Participants | cIAI/cUTI |
|---|---|
| Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (AE) | 4.9 (1.6 to 12.4) |
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.
| Percentage of Participants | cIAI |
|---|---|
| Percentage of Complicated Intra-Abdominal Infection (cIAI) Participants With Favorable Clinical Response at End of Therapy Visit | 85.7 (67.9 to 94.9) |
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.
| Percentage of Participants | cUTI |
|---|---|
| Percentage of Complicated Urinary Tract Infection (cUTI) Participants With Favorable Overall Microbiological Response at End of Therapy Visit | 100 (89.3 to 100.0) |
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.
| Percentage of Participants | cIAI |
|---|---|
| Percentage of Complicated Intra-Abdominal Infection (cIAI) Participants With Favorable Clinical Response at Test of Cure Visit | 82.1 (63.9 to 92.6) |
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.
| Percentage of Participants | cUTI |
|---|---|
| Percentage of Complicated Urinary Tract Infection (cUTI) Participants With Favorable Overall Microbiological Response at Test of Cure Visit | 59.0 (43.4 to 72.9) |
Collected over Up to 28 days (up to 14 days after completion of intravenous study therapy). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| cIAI/cUTI | 1/81 (1.2%) | 9/81 (11.1%) | 18/81 (22.2%) |
| Event | cIAI/cUTI |
|---|---|
| Abdominal abscessInfections and infestations | 2/81 |
| Rhegmatogenous retinal detachmentEye disorders | 1/81 |
| Large intestine perforationGastrointestinal disorders | 1/81 |
| Pancreatitis acuteGastrointestinal disorders | 1/81 |
| Cholecystitis acuteHepatobiliary disorders | 1/81 |
| Pelvic abscessInfections and infestations | 1/81 |
| PeritonitisInfections and infestations | 1/81 |
| Postoperative ileusInjury, poisoning and procedural complications | 1/81 |
| Acute kidney injuryRenal and urinary disorders | 1/81 |
| Renal haematomaRenal and urinary disorders | 1/81 |
| Event | cIAI/cUTI |
|---|---|
| DiarrhoeaGastrointestinal disorders | 7/81 |
| NauseaGastrointestinal disorders | 7/81 |
| NasopharyngitisInfections and infestations | 5/81 |
| Age, Continuous(Years) | cIAI/cUTI |
|---|---|
| Mean | 62.8 ± 18.2 |
| Sex: Female, Male(Participants) | cIAI/cUTI |
|---|---|
| Female | 45 |
| Male | 38 |
| Ethnicity (NIH/OMB)(Participants) | cIAI/cUTI |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 83 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | cIAI/cUTI |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 83 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Infection Type(Participants) | cIAI/cUTI |
|---|---|
| cIAI | 39 |
| cUTI | 44 |
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Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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