Trial · NCT03583333
Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Piperacillin/Tazobactam in Participants With Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia (MK-7655A-016)
NCT03583333, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2023-06-28
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Piperacillin/Tazobactam in Participants With Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia (MK-7655A-016). Trials, record NCT03583333. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03583333
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Piperacillin/Tazobactam in Participants With Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia (MK-7655A-016)
- NCT number
- NCT03583333
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 274 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Hospital-Acquired Bacterial Pneumonia, Ventilator-Associated Bacterial Pneumonia
- Interventions
- IMI/REL FDC, PIP/TAZ FDC, Linezolid
- First posted
- 2018-07-11
- Last updated
- 2025-01-29
- Other registries' IDs
- eudract:2018-003202-82
- Results first posted
- 2023-06-28
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With All-cause Mortality Through Day 28 in the Modified Intent to Treat (MITT) Population | Up to approximately 28 days | For each participant, survival status was assessed at Day 28 post-randomization and recorded on the electronic Case Report Form. The percentage of participants with all-cause mortality through Day 28 in the MITT population is presented. |
| Secondary | Percentage of Participants Achieving a Favorable Clinical Response at Early Follow-up (EFU) Visit in the MITT Population | Up to approximately 27 days | Clinical response was defined as "Sustained cure" (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status with no evidence of resurgence AND no additional antibiotic therapy was required for the index infection) or "Cure" (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status AND no additional antibiotic therapy was required for the index infection). The percentage of participants achieving a favorable clinical response at EFU visit in the MITT population is presented. |
| Secondary | Percentage of Participants Achieving a Favorable Clinical Response at EFU Visit in the Clinically Evaluable (CE) Population | Up to approximately 27 days | Clinical response was defined as "Sustained cure" (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status with no evidence of resurgence) AND no additional antibiotic therapy was required for the index infection or "Cure" (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status) AND no additional antibiotic therapy was required for the index infection. The percentage of participants achieving a favorable clinical response at EFU visit in the CE population is presented. |
| Secondary | Percentage of Participants Achieving a Favorable Clinical Response at End of Therapy (EOT) Visit in the MITT Population | Up to approximately 14 days | Clinical response was defined as "Improved" (The majority of pre-therapy signs and symptoms of the index infection have improved or resolved or returned to "pre-infection status" AND no additional antibiotic therapy was required) or "Cure" (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status AND no additional antibiotic therapy was required for the index infection). The percentage of participants achieving a favorable clinical response at EOT visit in the MITT population is presented. |
| Secondary | Percentage of Participants Achieving a Favorable Clinical Response at EOT Visit in the Clinically Evaluable (CE) Population | Up to approximately 14 days | Clinical response was defined as "Improved" (The majority of pre-therapy signs and symptoms of the index infection have improved or resolved or returned to "pre-infection status" AND no additional antibiotic therapy is required) or "Cure" (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status) AND no additional antibiotic therapy is required for the index infection. The percentage of participants achieving a favorable clinical response at End of Treatment (EOT) visit in the CE population is presented. |
| Secondary | Percentage of Participants Achieving a Favorable Microbiological Response at EOT Visit in Microbiological Modified Intent-To-Treat Population (mMITT) Population | Up to approximately 14 days | Favorable overall microbiological response rates were defined as "eradication" (A lower respiratory tract culture taken at the EOT visit showed eradication of the pathogen found at study entry) OR "presumed eradication" (No specimen taken because participant was deemed clinically cured or improved) of the baseline pathogen. The percentage of participants achieving a favorable microbiological response at EOT visit in the mMITT population is presented. |
| Secondary | Percentage of Participants Achieving a Favorable Microbiological Response at EFU Visit in Microbiological-evaluable (ME) Population. | Up to approximately 27 days | A favorable by-pathogen microbiological response at EFU visit required "eradication" (A lower respiratory tract culture taken at the EFU visit showed eradication of the pathogen found at study entry) or "presumed eradication" (No specimen taken because participant was deemed clinically cured or improved) of the baseline pathogen. The percentage of participants achieving a favorable microbiological response at EFU visit in the ME population is presented. |
| Secondary | Percentage of Participants Achieving a Favorable Microbiological Response at EOT Visit in the ME Population | Up to approximately 14 days | Favorable overall microbiological response rates was defined as "eradication" (A lower respiratory tract culture taken at the EOT visit showed eradication of the pathogen found at study entry) OR "presumed eradication" (No specimen taken because participant was deemed clinically cured or improved) of the baseline pathogen. The percentage of participants achieving a favorable microbiological response at End of Treatment (EOT) visit in the ME population is presented. |
| Secondary | Percentage of Participants Experiencing Adverse Events (AEs) | Up to approximately 98 days | An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants experiencing an AE was reported for each arm. |
| Secondary | Percentage of Participants Discontinuing Study Drug Due to AEs | Up to approximately 14 days | An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants that discontinued study therapy due to an AE was reported for each arm. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With All-cause Mortality Through Day 28 in the Modified Intent to Treat (MITT) Population | Up to approximately 28 days | The MITT population consisting of all randomized participants who received at least 1 dose of IV study therapy and did not have the presence of positive cocci only on baseline Gram stain were analyzed. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a Favorable Clinical Response at Early Follow-up (EFU) Visit in the MITT Population | Up to approximately 27 days | MITT population consisting of all randomized participants who received at least 1 dose of IV study therapy and did not have the presence of positive cocci only on baseline Gram stain. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a Favorable Clinical Response at EFU Visit in the Clinically Evaluable (CE) Population | Up to approximately 27 days | MITT population consisting of all randomized participants who received at least 1 dose of IV study therapy and did not have the presence of positive cocci only on baseline Gram stain. The CE population was a subset of the MITT population who also met important diagnostic criteria for entry into the study, had no significant deviation from the protocol and received the minimum duration of IV study therapy. Only participants with non-missing/non-indeterminate response were assessed at EFU visit. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a Favorable Clinical Response at End of Therapy (EOT) Visit in the MITT Population | Up to approximately 14 days | MITT population consisting of all randomized participants who received at least 1 dose of IV study therapy and did not have the presence of positive cocci only on baseline Gram stain were analyzed. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a Favorable Clinical Response at EOT Visit in the Clinically Evaluable (CE) Population | Up to approximately 14 days | MITT population consisting of all randomized participants who received at least 1 dose of IV study therapy and did not have the presence of positive cocci only on baseline Gram stain. The CE population was a subset of the MITT population who also met important diagnostic criteria for entry into the study, had no significant deviation from the protocol and received the minimum duration of IV study therapy. Only participants with non-missing/non-indeterminate response were assessed at EOT visit. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a Favorable Microbiological Response at EOT Visit in Microbiological Modified Intent-To-Treat Population (mMITT) Population | Up to approximately 14 days | The MITT population consisted of all randomized participants who received at least 1 dose of IV study therapy and did not have the presence of positive cocci. The microbiological modified intention-to-treat (mMITT) population was a subset of the MITT population that possessed a baseline bacterial pathogen isolated from a lower respiratory tract (LRT) specimen that was identified as the cause of HABP/VABP and against which IMI/REL has been shown to have antibacterial activity. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a Favorable Microbiological Response at EFU Visit in Microbiological-evaluable (ME) Population. | Up to approximately 27 days | All randomized participants receiving ≥1 dose of IV study therapy without presence of positive cocci (MITT); who met important diagnostic criteria for study with no significant protocol deviation and received minimum duration of IV study therapy (CE); had a baseline bacterial pathogen cause of HABP/VABP against which IMI/REL has antibacterial activity and results from a lower respiratory tract culture obtained at indicated time point (ME); and had non-missing/non-indeterminate response at EFU. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a Favorable Microbiological Response at EOT Visit in the ME Population | Up to approximately 14 days | All randomized participants receiving ≥1 dose of IV study therapy without presence of positive cocci (MITT); who met important diagnostic criteria for study with no significant protocol deviation and received minimum duration of IV study therapy (CE); had a baseline bacterial pathogen cause of HABP/VABP against which IMI/REL has antibacterial activity and results from a lower respiratory tract culture obtained at indicated time point (ME); and had non-missing/non-indeterminate response at EOT. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Experiencing Adverse Events (AEs) | Up to approximately 98 days | All randomized participants who received at least 1 dose of IV study therapy were assessed. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Discontinuing Study Drug Due to AEs | Up to approximately 14 days | All randomized participants who received at least 1 dose of IV study therapy were assessed. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With All-cause Mortality Through Day 28 in the Modified Intent to Treat (MITT) Population | IMI/REL FDC | 11.2 | Percentage of Participants | ||
| Percentage of Participants With All-cause Mortality Through Day 28 in the Modified Intent to Treat (MITT) Population | PIP/TAZ FDC | 5.9 | Percentage of Participants | ||
| Percentage of Participants Achieving a Favorable Clinical Response at Early Follow-up (EFU) Visit in the MITT Population | IMI/REL FDC | 50.7 | Percentage of Participants | ||
| Percentage of Participants Achieving a Favorable Clinical Response at Early Follow-up (EFU) Visit in the MITT Population | PIP/TAZ FDC | 47.8 | Percentage of Participants | ||
| Percentage of Participants Achieving a Favorable Clinical Response at EFU Visit in the Clinically Evaluable (CE) Population | IMI/REL FDC | 64.6 | Percentage of Participants | ||
| Percentage of Participants Achieving a Favorable Clinical Response at EFU Visit in the Clinically Evaluable (CE) Population | PIP/TAZ FDC | 62.2 | Percentage of Participants | ||
| Percentage of Participants Achieving a Favorable Clinical Response at End of Therapy (EOT) Visit in the MITT Population | IMI/REL FDC | 71.6 | Percentage of Participants | ||
| Percentage of Participants Achieving a Favorable Clinical Response at End of Therapy (EOT) Visit in the MITT Population | PIP/TAZ FDC | 68.4 | Percentage of Participants | ||
| Percentage of Participants Achieving a Favorable Clinical Response at EOT Visit in the Clinically Evaluable (CE) Population | IMI/REL FDC | 77.4 | Percentage of Participants | ||
| Percentage of Participants Achieving a Favorable Clinical Response at EOT Visit in the Clinically Evaluable (CE) Population | PIP/TAZ FDC | 82.3 | Percentage of Participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | IMI/REL FDC | 138 | |
| Overall Study | STARTED | PIP/TAZ FDC | 136 | |
| Overall Study | Treated | IMI/REL FDC | 134 | |
| Overall Study | Treated | PIP/TAZ FDC | 136 | |
| Overall Study | COMPLETED | IMI/REL FDC | 90 | |
| Overall Study | COMPLETED | PIP/TAZ FDC | 106 | |
| Overall Study | NOT COMPLETED | IMI/REL FDC | 48 | |
| Overall Study | NOT COMPLETED | PIP/TAZ FDC | 30 |
Source ClinicalTrials.gov
Adverse events116
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 | Anaemia | Blood and lymphatic system disorders | IMI/REL | 18 | 134 | 20 |
| other | Anaemia | Blood and lymphatic system disorders | PIP/TAZ | 17 | 136 | 17 |
| other | Constipation | Gastrointestinal disorders | IMI/REL | 15 | 134 | 15 |
| other | Constipation | Gastrointestinal disorders | PIP/TAZ | 9 | 136 | 10 |
| other | Diarrhoea | Gastrointestinal disorders | IMI/REL | 21 | 134 | 27 |
| other | Diarrhoea | Gastrointestinal disorders | PIP/TAZ | 22 | 136 | 25 |
| other | Vomiting | Gastrointestinal disorders | IMI/REL | 8 | 134 | 11 |
| other | Vomiting | Gastrointestinal disorders | PIP/TAZ | 6 | 136 | 6 |
| other | Hepatic function abnormal | Hepatobiliary disorders | IMI/REL | 17 | 134 | 18 |
| other | Hepatic function abnormal | Hepatobiliary disorders | PIP/TAZ | 13 | 136 | 13 |
1 to 10 of 116Source ClinicalTrials.gov
See all 116 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IMI/REL | 18 | 138 |
| Total, all-cause mortality | PIP/TAZ | 11 | 136 |
| Total, other adverse events | IMI/REL | 81 | 134 |
| Total, other adverse events | PIP/TAZ | 66 | 136 |
| Total, serious adverse events | IMI/REL | 29 | 134 |
| Total, serious adverse events | PIP/TAZ | 21 | 136 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39674398 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| IMI/REL vs PIP/TAZ: deaths from any cause | Trial comparisons |
| IMI/REL vs PIP/TAZ: serious adverse events | Trial comparisons |
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/NCT03583333
GET https://conductscience.org/api/trials/v1/NCT03583333/events?page=2