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)
NCT03293485, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2019-09-17
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. 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). Trials, record NCT03293485. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03293485
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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 number
- NCT03293485
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 83 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Complicated Intra-abdominal Infection, Complicated Urinary Tract Infection
- Interventions
- Imipenem+Cilastatin/Relebactam
- First posted
- 2017-09-26
- Last updated
- 2021-02-12
- Results first posted
- 2019-09-17
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Experiencing ≥1 Adverse Events (AE) | Up to 28 days | 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. |
| Primary | Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (AE) | Up to 14 days (End of Therapy Visit) | 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. |
| Primary | Percentage of Complicated Intra-Abdominal Infection (cIAI) Participants With Favorable Clinical Response at End of Therapy Visit | Between Day 5 and Day 14 (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. |
| Primary | Percentage of Complicated Urinary Tract Infection (cUTI) Participants With Favorable Overall Microbiological Response at End of Therapy Visit | Between Day 5 and Day 14 (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. |
| Secondary | Percentage of Complicated Intra-Abdominal Infection (cIAI) Participants With Favorable Clinical Response at Test of Cure Visit | Between Day 10 and Day 23 (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. |
| Secondary | Percentage of Complicated Urinary Tract Infection (cUTI) Participants With Favorable Overall Microbiological Response at Test of Cure Visit | Between Day 10 and Day 23 (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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Experiencing ≥1 Adverse Events (AE) | Up to 28 days | Per protocol, the population analyzed was all participants who received ≥1 dose of intravenous imipenem+cilastatin+relebactam. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (AE) | Up to 14 days (End of Therapy Visit) | Per protocol, the population analyzed was all participants who received ≥1 dose of intravenous imipenem+cilastatin+relebactam. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Complicated Intra-Abdominal Infection (cIAI) Participants With Favorable Clinical Response at End of Therapy Visit | Between Day 5 and Day 14 (End of Therapy Visit) | 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. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Complicated Urinary Tract Infection (cUTI) Participants With Favorable Overall Microbiological Response at End of Therapy Visit | Between Day 5 and Day 14 (End of Therapy Visit) | 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. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Complicated Intra-Abdominal Infection (cIAI) Participants With Favorable Clinical Response at Test of Cure Visit | Between Day 10 and Day 23 (Test of Cure Visit) | 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. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Complicated Urinary Tract Infection (cUTI) Participants With Favorable Overall Microbiological Response at Test of Cure Visit | Between Day 10 and Day 23 (Test of Cure Visit) | 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. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Experiencing ≥1 Adverse Events (AE) | cIAI/cUTI | 74.1 | 95% Confidence Interval 63.5 to 82.4 | Percentage of Participants | |
| Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (AE) | cIAI/cUTI | 4.9 | 95% Confidence Interval 1.6 to 12.4 | Percentage of Participants | |
| Percentage of Complicated Intra-Abdominal Infection (cIAI) Participants With Favorable Clinical Response at End of Therapy Visit | cIAI | 85.7 | 95% Confidence Interval 67.9 to 94.9 | Percentage of Participants | |
| Percentage of Complicated Urinary Tract Infection (cUTI) Participants With Favorable Overall Microbiological Response at End of Therapy Visit | cUTI | 100 | 95% Confidence Interval 89.3 to 100.0 | Percentage of Participants | |
| Percentage of Complicated Intra-Abdominal Infection (cIAI) Participants With Favorable Clinical Response at Test of Cure Visit | cIAI | 82.1 | 95% Confidence Interval 63.9 to 92.6 | Percentage of Participants | |
| Percentage of Complicated Urinary Tract Infection (cUTI) Participants With Favorable Overall Microbiological Response at Test of Cure Visit | cUTI | 59.0 | 95% Confidence Interval 43.4 to 72.9 | Percentage of Participants |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | cIAI/cUTI | 83 | |
| Overall Study | Treated | cIAI/cUTI | 81 | |
| Overall Study | COMPLETED | cIAI/cUTI | 78 | |
| Overall Study | NOT COMPLETED | cIAI/cUTI | 5 |
Source ClinicalTrials.gov
Adverse events13
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | cIAI/cUTI | 7 | 81 | 7 |
| other | Nausea | Gastrointestinal disorders | cIAI/cUTI | 7 | 81 | 9 |
| other | Nasopharyngitis | Infections and infestations | cIAI/cUTI | 5 | 81 | 5 |
| serious | Rhegmatogenous retinal detachment | Eye disorders | cIAI/cUTI | 1 | 81 | 1 |
| serious | Large intestine perforation | Gastrointestinal disorders | cIAI/cUTI | 1 | 81 | 1 |
| serious | Pancreatitis acute | Gastrointestinal disorders | cIAI/cUTI | 1 | 81 | 1 |
| serious | Cholecystitis acute | Hepatobiliary disorders | cIAI/cUTI | 1 | 81 | 1 |
| serious | Abdominal abscess | Infections and infestations | cIAI/cUTI | 2 | 81 | 2 |
| serious | Pelvic abscess | Infections and infestations | cIAI/cUTI | 1 | 81 | 1 |
| serious | Peritonitis | Infections and infestations | cIAI/cUTI | 1 | 81 | 1 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | cIAI/cUTI | 1 | 81 |
| Total, other adverse events | cIAI/cUTI | 18 | 81 |
| Total, serious adverse events | cIAI/cUTI | 9 | 81 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33191112 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03293485
GET https://conductscience.org/api/trials/v1/NCT03293485/registered