Bacterial PneumoniaPhase 3RESTORE-IMI 2NCT02493764
Imipenem/Relebactam/Cilastatin Versus Piperacillin/Tazobactam for Treatment of Participants With Bacterial Pneumonia (MK-7655A-014)
A Phase 3 study testing Imipenem, Relebactam and Cilastatin in people with Bacterial Pneumonia, run by Merck Sharp & Dohme LLC.
Trial summary
This study aims to compare treatment with a fixed-dose combination (FDC) of imipenem/relebactam/cilastatin (IMI/REL) with a FDC of piperacillin/tazobactam (PIP/TAZ) in participants with hospital-acquired or ventilator-associated bacterial pneumonia (HABP or VAPB, respectively). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacterial Pneumonia
- What is being tested?
- Imipenem, Relebactam and Cilastatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 537 participants
- Where
- No sites listed yet
- Study dates
- 24 Nov 2015to 3 Apr 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Requires treatment with IV antibiotic therapy for hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP)
- Fulfills clinical and radiographic criteria, with onset of criteria occurring after more than 48 hours of hospitalization or within 7 days after discharge from a hospital (for HABP); or at least 48 hours after mechanical ventilation (for VABP)
- Has an adequate baseline lower respiratory tract specimen obtained for Gram stain and culture
- Has an infection known or thought to be caused by microorganisms susceptible to the IV study therapy
- Agrees to allow any bacterial isolates obtained from protocol-required specimens related to the current infection to be provided to the Central Microbiology Reference Laboratory for study-related microbiological testing, long term storage, and other future testing
- Is not of reproductive potential; or if of reproductive potential agrees to avoid impregnating a partner or avoid becoming pregnant, by practicing abstinence or using acceptable contraception
Who cannot join
- Has a baseline lower respiratory tract specimen Gram stain that shows the presence of Gram-positive cocci only
- Has confirmed or suspected community-acquired bacterial pneumonia (CABP)
- Has confirmed or suspected pneumonia of viral, fungal or parasitic origin
- Has HABP/VABP caused by an obstructive process, including lung cancer or other known obstruction
- Has a carcinoid tumor or carcinoid syndrome
- Has active immunosuppression defined as either receiving immunosuppressive medications or having a medical condition associated with immunodeficiency
Show all 16Show fewer
- Is expected to survive for less than 72 hours
- Has a concurrent condition or infection that would preclude evaluation of therapeutic response
- Has received effective antibacterial drug therapy for the index infection of HABP/VABP for more than 24 hours continuously, during the previous 72 hours
- Has a history of serious allergy, hypersensitivity or a serious reaction to any penicillin or beta-lactamase inhibitors
- Female is pregnant, expecting to conceive, is breastfeeding or plans to breastfeed
- Has a history of seizure disorder requiring ongoing prior treatment with anti-convulsive therapy within the last 3 years
- Anticipates treatment with the following: valproic acid or divalproex sodium, serotonin re-uptake inhibitors, tricyclic antidepressants, or serotonin receptor antagonists, meperidine, buspirone, concomitant systemic antibacterial agents, antifungal or antiviral therapy for the index infection of HABP/VABP
- Is currently undergoing hemodialysis or peritoneal dialysis
- Is currently participating in, has participated in during the previous 30 days, or anticipates to participate in any other clinical study involving the administration of experimental medication
- Has previously participated in this study
About this study
Official title: A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Study the Safety, Tolerability, and Efficacy of Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Piperacillin/Tazobactam in Subjects With Hospital-Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial Pneumonia
This study aims to compare treatment with a fixed-dose combination (FDC) of imipenem/relebactam/cilastatin (IMI/REL) with a FDC of piperacillin/tazobactam (PIP/TAZ) in participants with hospital-acquired or ventilator-associated bacterial pneumonia (HABP or VAPB, respectively). The primary hypothesis is that IMI/REL is non-inferior to PIP/TAZ in the incidence rate of all-cause mortality.
- Conditions
- Bacterial Pneumonia
- Being tested
- Imipenem, Relebactam, Cilastatin, Piperacillin, Tazobactam
- Medical subject headings
- Pneumonia, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImipenemDrug
Imipenem 500 mg as part of a FDC administered by IV every 6 hours for a minimum of 7 days, up to 14 days
RelebactamDrug
Relebactam 250 mg as part of a FDC administered by IV every 6 hours for a minimum of 7 days, up to 14 days
CilastatinDrug
Cilastatin 500 mg as part of a FDC administered by IV every 6 hours for a minimum of 7 days, up to 14 days
PiperacillinDrug
Piperacillin 4000 mg as part of a FDC administered by IV every 6 hours for a minimum of 7 days, up to 14 days
TazobactamDrug
Tazobactam 500 mg as part of a FDC administered by IV every 6 hours for a minimum of 7 days, up to 14 days
LinezolidDrug
Linezolid 600 mg administered open-label by IV every 12 hours for up to 14 days
| Study group | Role | What they receive |
|---|---|---|
| IMI/REL | Experimental | Imipenem 500 mg + relebactam 250 mg + cilastatin 500 mg as a FDC administered intravenously (IV) every 6 hours for a minimum of 7 days, up to 14 days. At study entry open label linezolid 600 mg will also be administered by IV every 12 hours for up to 14 days. Receives: Drug: Imipenem; Drug: Relebactam; Drug: Cilastatin; Drug: Linezolid |
| PIP/TAZ | Active comparator | Piperacillin 4000 mg + tazobactam 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At study entry open label linezolid 600 mg will also be administered by IV every 12 hours for up to 14 days. Receives: Drug: Piperacillin; Drug: Tazobactam; Drug: Linezolid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With All-cause Mortality (ACM) Through Day 28 in the Modified Intention-to-treat (MITT) Population
The percentage of participants in the MITT population with mortality due to any cause from randomization through Day 28 was determined for each arm.
Measured: Up to 28 days
Secondary outcomes (21)
Percentage of Participants in the MITT Population With a Favorable Clinical Response (FCR) at Early Follow-up (EFU) Visit
The percentage of participants with a FCR at EFU was determined for each arm. Favorable clinical response at EFU was defined as either "sustained cure" (all pre-therapy signs and symptoms of the index infection have resolved [or returned to "pre-infection status"] with no evidence of resurgence and no additional antibiotics are required) or "cure" (all pre-therapy signs and symptoms of the index infection have resolved [or returned to "pre-infection status"] and no additional antibiotics are required).
Measured: Up to 16 days after end of therapy (up to 30 days)
Percentage of Participants With ≥1 Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Measured: Up to 30 days
Percentage of Participants Discontinuing Study Therapy Due to an AE
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Measured: Up to 14 days
Percentage of Participants With ACM in the Microbiological Modified Intention-to-treat (mMITT) Population
The percentage of participants in the mMITT population with mortality due to any cause from randomization through Day 28 was determined for each arm.
Measured: Up to 28 days
Percentage of Participants With ACM at EFU in the MITT Population
The percentage of participants in the MITT population with mortality due to any cause from randomization through EFU was determined for each arm.
Measured: Up to 16 days after end of therapy (up to 30 days)
Percentage of Participants With ACM at EFU in the mMITT Population
The percentage of participants in the mMITT population with mortality due to any cause from randomization through EFU was determined for each arm.
Measured: Up to 16 days after end of therapy (up to 30 days)
Percentage of Participants in the Clinically Evaluable (CE) Population With a FCR at On-therapy Visit 1 (OTX1) [Day 3]
The percentage of participants with a FCR at OTX1 was determined for each arm. Favorable clinical response at OTX1 was defined as "improved" (majority of pre-therapy signs and symptoms of the index infection have improved or resolved [or returned to "pre-infection status"]).
Measured: Day 3 (OTX1)
Percentage of Participants in the CE Population With a FCR at OTX2 (Day 6)
The percentage of participants with a FCR at OTX2 was determined for each arm. Favorable clinical response at OTX2 was defined as "improved" (majority of pre-therapy signs and symptoms of the index infection have improved or resolved [or returned to "pre-infection status"]).
Measured: Day 6 (OTX2)
Percentage of Participants in the CE Population With a FCR at OTX3 (Day 10)
The percentage of participants with a FCR at OTX3 was determined for each arm. Favorable clinical response at OTX3 was defined as "improved" (majority of pre-therapy signs and symptoms of the index infection have improved or resolved [or returned to "pre-infection status"]).
Measured: Day 10 (OTX3)
Percentage of Participants in the CE Population With a FCR at EOT Visit
The percentage of participants with a FCR at EOT was determined for each arm. Favorable clinical response at EOT was defined as either "cure" (all pre-therapy signs and symptoms of the index infection have resolved [or returned to "pre-infection status"] and no additional antibiotics are required) or "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 antibiotics are required).
Measured: From Day 7 to Day 14
Percentage of Participants in the CE Population With a FCR at Day 28
The percentage of participants with a FCR at Day 28 was determined for each arm. Favorable clinical response at Day 28 was defined as either "sustained cure" (all pre-therapy signs and symptoms of the index infection have resolved [or returned to "pre-infection status"] with no evidence of resurgence and no additional antibiotics are required) or "cure" (all pre-therapy signs and symptoms of the index infection have resolved [or returned to "pre-infection status"] and no additional antibiotics are required).
Measured: Day 28
Percentage of Participants in the CE Population With a FCR at EFU Visit
The percentage of participants with a FCR at EFU was determined for each arm. Favorable clinical response at EFU was defined as either "sustained cure" (all pre-therapy signs and symptoms of the index infection have resolved [or returned to "pre-infection status"] with no evidence of resurgence and no additional antibiotics are required) or "cure" (all pre-therapy signs and symptoms of the index infection have resolved [or returned to "pre-infection status"] and no additional antibiotics are required).
Measured: Up to 16 days after end of therapy (up to Day 30)
Percentage of Participants in the MITT Population With a FCR at OTX1 (Day 3)
The percentage of participants with a FCR at OTX1 was determined for each arm. Favorable clinical response at OTX1 was defined as "improved" (majority of pre-therapy signs and symptoms of the index infection have improved or resolved [or returned to "pre-infection status"]).
Measured: Day 3 (OTX1)
Percentage of Participants in the MITT Population With a FCR at OTX2 (Day 6)
The percentage of participants with a FCR at OTX2 was determined for each arm. Favorable clinical response at OTX2 was defined as "improved" (majority of pre-therapy signs and symptoms of the index infection have improved or resolved [or returned to "pre-infection status"]).
Measured: Day 6 (OTX2)
Percentage of Participants in the MITT Population With a FCR at OTX3 (Day 10)
The percentage of participants with a FCR at OTX3 was determined for each arm. Favorable clinical response at OTX3 was defined as "improved" (majority of pre-therapy signs and symptoms of the index infection have improved or resolved [or returned to "pre-infection status"]).
Measured: Day 10 (OTX3)
Percentage of Participants in the MITT Population With a FCR at EOT
The percentage of participants with a FCR at EOT was determined for each arm. Favorable clinical response at EOT was defined as either "cure" (all pre-therapy signs and symptoms of the index infection have resolved [or returned to "pre-infection status"] and no additional antibiotics are required) or "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 antibiotics are required).
Measured: From Day 7 to Day 14
Percentage of Participants in the MITT Population With a FCR at Day 28
The percentage of participants with a FCR at Day 28 was determined for each arm. Favorable clinical response at Day 28 was defined as either "sustained cure" (all pre-therapy signs and symptoms of the index infection have resolved [or returned to "pre-infection status"] with no evidence of resurgence and no additional antibiotics are required) or "cure" (all pre-therapy signs and symptoms of the index infection have resolved [or returned to "pre-infection status"] and no additional antibiotics are required).
Measured: Day 28
Percentage of Participants in the mMITT Population With a Favorable Microbiological Response (FMR) at End of Treatment (EOT) Visit
The percentage of participants with a FMR at EOT was determined for each arm. Favorable microbiological response at EOT was defined as either "eradication" (a lower respiratory tract culture taken at EOT showing eradication of baseline pathogen) or "presumed eradication" (no specimen collected because the participant deemed clinically cured or improved).
Measured: From Day 7 to Day 14
Percentage of Participants in the mMITT Population With a FMR at EFU Visit
The percentage of participants with a FMR at EFU was determined for each arm. Favorable microbiological response at EOT was defined as either "eradication" (a lower respiratory tract culture taken at EFU showing eradication of baseline pathogen) or "presumed eradication" (no specimen collected because the participant deemed clinically cured or improved).
Measured: Up to 16 days after end of therapy (up to Day 30)
Percentage of Participants in the Microbiologically Evaluable (ME) Population With a FMR at EOT Visit
The percentage of participants with a FMR at EOT was determined for each arm. Favorable microbiological response at EOT was defined as either "eradication" (a lower respiratory tract culture taken at EOT showing eradication of baseline pathogen) or "presumed eradication" (no specimen collected because the participant deemed clinically cured or improved).
Measured: From Day 7 to Day 14
Percentage of Participants in the ME Population With a FMR at EFU Visit
The percentage of participants with a FMR at EOT was determined for each arm. Favorable microbiological response at EOT was defined as either "eradication" (a lower respiratory tract culture taken at EOT showing eradication of baseline pathogen) or "presumed eradication" (no specimen collected because the participant deemed clinically cured or improved).
Measured: Up to 16 days after end of therapy (up to Day 30)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2015 (estimated)
- Study start24 Nov 2015
- Primary completion3 Apr 2019
- Study completion3 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Bacterial PneumoniaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 537 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02493764
- Sponsor's protocol ID
- 7655A-014
- Other IDs
- 2015-000246-34, 163240, MK-7655A-014, 2015
- Acronym
- RESTORE-IMI 2
- Status last verified
- Mar 2020
- First submitted
- 7 Jul 2015
- Last updated
- 16 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Publications
Young K, DeRyke CA, Hilbert DW, Losada MC, Du J, Paschke A, Chen LF. Imipenem/cilastatin/relebactam treatment of hospital-acquired/ventilator-associated bacterial pneumonia caused by imipenem-nonsusceptible pathogens: Subgroup analysis and molecular characterization of isolates from the RESTORE-IMI 2 clinical study. PLoS One. 2026 Sep 15;21(9):e0357288. doi: 10.1371/journal.pone.0357288. eCollection 2026.
PubMed 42743113Patel M, Nieddu G, DeRyke CA, Young K, Chen LF, Paschke A, Rizk ML, Gheyas F. Imipenem/cilastatin/relebactam dosing regimen justification using exposure-efficacy analyses in participants with hospital-acquired bacterial pneumonia or ventilator-associated bacterial pneumonia in the RESTORE-IMI 2 phase 3 study. Antimicrob Agents Chemother. 2026 Mar 4;70(3):e0131325. doi: 10.1128/aac.01313-25. Epub 2026 Jan 26.
PubMed 41586496Martin-Loeches I, Shorr AF, Kollef MH, Du J, Losada MC, Paschke A, DeRyke CA, Wong M, Jensen EH, Chen LF. Participant- and Disease-Related Factors as Independent Predictors of Treatment Outcomes in the RESTORE-IMI 2 Clinical Trial: A Multivariable Regression Analysis. Open Forum Infect Dis. 2023 May 4;10(6):ofad225. doi: 10.1093/ofid/ofad225. eCollection 2023 Jun.
PubMed 37383243Patel M, Bellanti F, Daryani NM, Noormohamed N, Hilbert DW, Young K, Kulkarni P, Copalu W, Gheyas F, Rizk ML. Population pharmacokinetic/pharmacodynamic assessment of imipenem/cilastatin/relebactam in patients with hospital-acquired/ventilator-associated bacterial pneumonia. Clin Transl Sci. 2022 Feb;15(2):396-408. doi: 10.1111/cts.13158. Epub 2021 Oct 27.
PubMed 34704389Titov I, Wunderink RG, Roquilly A, Rodriguez Gonzalez D, David-Wang A, Boucher HW, Kaye KS, Losada MC, Du J, Tipping R, Rizk ML, Patel M, Brown ML, Young K, Kartsonis NA, Butterton JR, Paschke A, Chen LF. A Randomized, Double-blind, Multicenter Trial Comparing Efficacy and Safety of Imipenem/Cilastatin/Relebactam Versus Piperacillin/Tazobactam in Adults With Hospital-acquired or Ventilator-associated Bacterial Pneumonia (RESTORE-IMI 2 Study). Clin Infect Dis. 2021 Dec 6;73(11):e4539-e4548. doi: 10.1093/cid/ciaa803.
PubMed 32785589
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Study the Safety, Tolerability, and Efficacy of Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Piperacillin/Tazobactam in Subjects With Hospital-Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial Pneumonia
- ClinicalTrials.gov ID
- NCT02493764
- Acronym / sponsor ID
- RESTORE-IMI 2 / 7655A-014
- Conditions
- Bacterial Pneumonia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 537 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 24 Nov 2015 (actual)
- Primary completion
- 3 Apr 2019 (actual)
- Study completion
- 3 Apr 2019 (actual)
- First posted
- 9 Jul 2015 (estimated)
- Results
- Posted 16 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to compare treatment with a fixed-dose combination (FDC) of imipenem/relebactam/cilastatin (IMI/REL) with a FDC of piperacillin/tazobactam (PIP/TAZ) in participants with hospital-acquired or ventilator-associated bacterial pneumonia (HABP or VAPB, respectively). The primary hypothesis is that IMI/REL is non-inferior to PIP/TAZ in the incidence rate of all-cause mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMI/REL | Experimental | Drug: Imipenem, Drug: Relebactam, Drug: Cilastatin, Drug: LinezolidImipenem 500 mg + relebactam 250 mg + cilastatin 500 mg as a FDC administered intravenously (IV) every 6 hours for a minimum of 7 days, up to 14 days. At study entry open label linezolid 600 mg will also be administered by IV every 12 hours for up to 14 days. |
| PIP/TAZ | Active comparator | Drug: Piperacillin, Drug: Tazobactam, Drug: LinezolidPiperacillin 4000 mg + tazobactam 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At study entry open label linezolid 600 mg will also be administered by IV every 12 hours for up to 14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Requires treatment with IV antibiotic therapy for hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP)
- Fulfills clinical and radiographic criteria, with onset of criteria occurring after more than 48 hours of hospitalization or within 7 days after discharge from a hospital (for HABP); or at least 48 hours after mechanical ventilation (for VABP)
- Has an adequate baseline lower respiratory tract specimen obtained for Gram stain and culture
- Has an infection known or thought to be caused by microorganisms susceptible to the IV study therapy
- Agrees to allow any bacterial isolates obtained from protocol-required specimens related to the current infection to be provided to the Central Microbiology Reference Laboratory for study-related microbiological testing, long term storage, and other future testing
Key exclusion criteria (16 listed)
- Has a baseline lower respiratory tract specimen Gram stain that shows the presence of Gram-positive cocci only
- Has confirmed or suspected community-acquired bacterial pneumonia (CABP)
- Has confirmed or suspected pneumonia of viral, fungal or parasitic origin
- Has HABP/VABP caused by an obstructive process, including lung cancer or other known obstruction
- Has a carcinoid tumor or carcinoid syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImipenemImipenem 500 mg as part of a FDC administered by IV every 6 hours for a minimum of 7 days, up to 14 days | Drug | IMI/REL |
| RelebactamRelebactam 250 mg as part of a FDC administered by IV every 6 hours for a minimum of 7 days, up to 14 days | Drug | IMI/REL |
| CilastatinCilastatin 500 mg as part of a FDC administered by IV every 6 hours for a minimum of 7 days, up to 14 days | Drug | IMI/REL |
| PiperacillinPiperacillin 4000 mg as part of a FDC administered by IV every 6 hours for a minimum of 7 days, up to 14 days | Drug | PIP/TAZ |
| TazobactamTazobactam 500 mg as part of a FDC administered by IV every 6 hours for a minimum of 7 days, up to 14 days | Drug | PIP/TAZ |
| LinezolidLinezolid 600 mg administered open-label by IV every 12 hours for up to 14 days | Drug | IMI/REL, PIP/TAZ |
Primary outcome
Percentage of Participants With All-cause Mortality (ACM) Through Day 28 in the Modified Intention-to-treat (MITT) Population
Time frame: Up to 28 days
The percentage of participants in the MITT population with mortality due to any cause from randomization through Day 28 was determined for each arm.
21 secondary outcomes
Percentage of Participants in the MITT Population With a Favorable Clinical Response (FCR) at Early Follow-up (EFU) Visit
Time frame: Up to 16 days after end of therapy (up to 30 days)
Percentage of Participants With ≥1 Adverse Event (AE)
Time frame: Up to 30 days
Percentage of Participants Discontinuing Study Therapy Due to an AE
Time frame: Up to 14 days
Percentage of Participants With ACM in the Microbiological Modified Intention-to-treat (mMITT) Population
Time frame: Up to 28 days
Percentage of Participants With ACM at EFU in the MITT Population
Time frame: Up to 16 days after end of therapy (up to 30 days)
Percentage of Participants With ACM at EFU in the mMITT Population
Time frame: Up to 16 days after end of therapy (up to 30 days)
Percentage of Participants in the Clinically Evaluable (CE) Population With a FCR at On-therapy Visit 1 (OTX1) [Day 3]
Time frame: Day 3 (OTX1)
Percentage of Participants in the CE Population With a FCR at OTX2 (Day 6)
Time frame: Day 6 (OTX2)
Percentage of Participants in the CE Population With a FCR at OTX3 (Day 10)
Time frame: Day 10 (OTX3)
Percentage of Participants in the CE Population With a FCR at EOT Visit
Time frame: From Day 7 to Day 14
Percentage of Participants in the CE Population With a FCR at Day 28
Time frame: Day 28
Percentage of Participants in the CE Population With a FCR at EFU Visit
Time frame: Up to 16 days after end of therapy (up to Day 30)
Percentage of Participants in the MITT Population With a FCR at OTX1 (Day 3)
Time frame: Day 3 (OTX1)
Percentage of Participants in the MITT Population With a FCR at OTX2 (Day 6)
Time frame: Day 6 (OTX2)
Percentage of Participants in the MITT Population With a FCR at OTX3 (Day 10)
Time frame: Day 10 (OTX3)
Percentage of Participants in the MITT Population With a FCR at EOT
Time frame: From Day 7 to Day 14
Percentage of Participants in the MITT Population With a FCR at Day 28
Time frame: Day 28
Percentage of Participants in the mMITT Population With a Favorable Microbiological Response (FMR) at End of Treatment (EOT) Visit
Time frame: From Day 7 to Day 14
Percentage of Participants in the mMITT Population With a FMR at EFU Visit
Time frame: Up to 16 days after end of therapy (up to Day 30)
Percentage of Participants in the Microbiologically Evaluable (ME) Population With a FMR at EOT Visit
Time frame: From Day 7 to Day 14
Percentage of Participants in the ME Population With a FMR at EFU Visit
Time frame: Up to 16 days after end of therapy (up to Day 30)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42743113Young K, DeRyke CA, Hilbert DW, Losada MC, Du J, Paschke A, Chen LF. Imipenem/cilastatin/relebactam treatment of hospital-acquired/ventilator-associated bacterial pneumonia caused by imipenem-nonsusceptible pathogens: Subgroup analysis and molecular characterization of isolates from the RESTORE-IMI 2 clinical study. PLoS One. 2026 Sep 15;21(9):e0357288. doi: 10.1371/journal.pone.0357288. eCollection 2026.
- Derived from this study: PubMed 41586496Patel M, Nieddu G, DeRyke CA, Young K, Chen LF, Paschke A, Rizk ML, Gheyas F. Imipenem/cilastatin/relebactam dosing regimen justification using exposure-efficacy analyses in participants with hospital-acquired bacterial pneumonia or ventilator-associated bacterial pneumonia in the RESTORE-IMI 2 phase 3 study. Antimicrob Agents Chemother. 2026 Mar 4;70(3):e0131325. doi: 10.1128/aac.01313-25. Epub 2026 Jan 26.
- Derived from this study: PubMed 37383243Martin-Loeches I, Shorr AF, Kollef MH, Du J, Losada MC, Paschke A, DeRyke CA, Wong M, Jensen EH, Chen LF. Participant- and Disease-Related Factors as Independent Predictors of Treatment Outcomes in the RESTORE-IMI 2 Clinical Trial: A Multivariable Regression Analysis. Open Forum Infect Dis. 2023 May 4;10(6):ofad225. doi: 10.1093/ofid/ofad225. eCollection 2023 Jun.
- Derived from this study: PubMed 34704389Patel M, Bellanti F, Daryani NM, Noormohamed N, Hilbert DW, Young K, Kulkarni P, Copalu W, Gheyas F, Rizk ML. Population pharmacokinetic/pharmacodynamic assessment of imipenem/cilastatin/relebactam in patients with hospital-acquired/ventilator-associated bacterial pneumonia. Clin Transl Sci. 2022 Feb;15(2):396-408. doi: 10.1111/cts.13158. Epub 2021 Oct 27.
- Derived from this study: PubMed 32785589Titov I, Wunderink RG, Roquilly A, Rodriguez Gonzalez D, David-Wang A, Boucher HW, Kaye KS, Losada MC, Du J, Tipping R, Rizk ML, Patel M, Brown ML, Young K, Kartsonis NA, Butterton JR, Paschke A, Chen LF. A Randomized, Double-blind, Multicenter Trial Comparing Efficacy and Safety of Imipenem/Cilastatin/Relebactam Versus Piperacillin/Tazobactam in Adults With Hospital-acquired or Ventilator-associated Bacterial Pneumonia (RESTORE-IMI 2 Study). Clin Infect Dis. 2021 Dec 6;73(11):e4539-e4548. doi: 10.1093/cid/ciaa803.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Imipenem, Relebactam and Cilastatin in people with Bacterial Pneumonia, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With All-cause Mortality (ACM) Through Day 28 in the Modified Intention-to-treat (MITT) Population (time frame: Up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02493764, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2020.