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Hospital-Acquired Bacterial PneumoniaPhase 3NCT03583333

Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Piperacillin/Tazobactam in Participants With Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia (MK-7655A-016)

A Phase 3 study testing IMI/REL FDC, PIP/TAZ FDC and Linezolid in people with Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia, run by Merck Sharp & Dohme LLC at 68 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will evaluate the efficacy and safety of a FDC of imipenem/cilastatin (IMI) and relebactam (REL) [IMI/REL, MK-7655A] compared to piperacillin/tazobactam (PIP/TAZ) in the treatment of adults diagnosed with Hospital-Acquired Bacterial Pneumonia (HABP) or Ventilator-Associated Bacterial Pneumonia (VABP). Read more about this study

Who is it for?
Ages 18 to 90 years
What is being tested?
IMI/REL FDC, PIP/TAZ FDC and Linezolid
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
274 participants
Where
68 sitesin 8 countries
Study dates
18 Sep 2018to 12 Jul 2022
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 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Requires treatment with IV antibiotic therapy for HABP or VABP
  • Fulfills clinical and radiographic criteria within 48 hours prior to randomization, with onset of criteria occurring after more than 2 days of hospitalization or within 7 days after discharge from a hospital for HABP; or at least 2 days after mechanical ventilation (for VABP)
  • Has an adequate baseline (at or within 2 days of screening) lower respiratory tract specimen obtained for Gram stain and culture
  • Has an infection known or thought to be, in the opinion of the investigator, 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 and long-term storage
  • Males agree to use contraception as detailed in protocol from the time of providing informed consent through completion of the study and refrain from donating sperm during this period
  • Females are not pregnant, not breastfeeding, and are either: a.) Not a woman of childbearing potential (WOCBP) OR b.) A WOCBP who agrees to follow the contraceptive guidance from the time of providing informed consent through completion of the study
  • If a penicillin skin test is required by local clinical practice, the participant must have a negative skin test result for allergy to penicillin

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 caused by Mycoplasma, Chlamydia, or Legionella, or of viral, fungal, or parasitic etiology
  • Has HABP/VABP caused by an obstructive process, including lung cancer (or other malignancy metastatic to the lungs resulting in pulmonary obstruction) or other known obstruction
  • Has a carcinoid tumor or carcinoid syndrome
  • Has active immunosuppression
Show all 16Show fewer
  • Is expected to die during the 7- to 14-day treatment period, despite adequate antibiotic therapy
  • Has a concurrent condition or infection that, in the investigator's judgment, would preclude evaluation of therapeutic response
  • Has a history of serious allergy, hypersensitivity, or any serious reaction to any β-lactams or β-lactamase inhibitors
  • Has a history of a seizure disorder which has required ongoing treatment with anticonvulsive therapy or prior treatment with anti-convulsive therapy within the last 3 years
  • Is currently undergoing hemodialysis or peritoneal dialysis
  • A WOCBP who has a positive urine pregnancy test at screening
  • Has received effective antibacterial drug therapy with known coverage of pathogens that cause HABP/VABP for a continuous duration of more than 48 hours during the previous 72 hours
  • Is anticipated to be treated with any of the prohibited medications during the course of study therapy
  • Is currently participating in, or has participated in, any other clinical study involving the administration of investigational or experimental medication (not licensed by regulatory agencies) at the time of the presentation or during the previous 90 days prior to screening or is anticipated to participate in such a clinical study during the course of this trial
  • Has previously participated in this study at any time

Trial locations and contacts

68 sites in 8 countries.

68 sites in 8 countries

China45 sites

  • Beijing Chaoyang Hospital ( Site 0126)

    Beijing, Beijing Municipality, 100020

  • Peking University First Hospital ( Site 0131)

    Beijing, Beijing Municipality, 100034

  • Aero Space center hospital ( Site 0118)

    Beijing, Beijing Municipality, 100049

  • The Seventh Medical Center of PLA General Hospital-Intensive medicine ( Site 0157)

    Beijing, Beijing Municipality, 100073

  • Peking University Third Hospital ( Site 0115)

    Beijing, Beijing Municipality, 100191

  • Beijing Hospital ( Site 0127)

    Beijing, Beijing Municipality, 100730

  • Changsha Central Hospital ( Site 0119)

    Changsha, Hunan, 410004

  • Hunan Provincial People Hospital ( Site 0122)

    Changsha, Hunan, 410005

  • The First People's Hospital of Changzhou ( Site 0139)

    Changzhou, Jiangsu, 213003

  • The First Affiliated Hospital Of Fujian Medical University-Respiratory ( Site 0136)

    Fuzhou, Fujian, 350005

  • The First Affiliated Hospital ( Site 0100)

    Guangzhou, Guangdong, 510080

  • The First Affiliated Hospital of Guangzhou Medical University ( Site 0123)

    Guangzhou, Guangdong, 510120

  • Guangzhou First People's Hospital ( Site 0101)

    Guangzhou, Guangdong, 510180

  • Zhujiang Hospital of Southern Medical University ( Site 0148)

    Guangzhou, Guangdong, 510280

  • Southern Medical University Nanfang Hospital ( Site 0120)

    Guangzhou, Guangdong, 510515

  • Hainan General Hospital ( Site 0106)

    Haikou, Hainan, 570311

  • The First Affiliated Hospital.Zhejiang University ( Site 0102)

    Hangzhou, Zhejiang, 310003

  • Sir Run Run Shaw Hospital School of Medicine Zhejiang University ( Site 0110)

    Hangzhou, Zhejiang, 310016

  • First Huai'an Hospital Affiliated to Nanjing Medical University-Neurosurgery Department ( Site 0153)

    Huai'an, Jiangsu, 223300

  • Huizhou Municipal Central Hospital ( Site 0140)

    Huizhou, Guangdong

  • People's Hospital of Liaocheng City-Neurology ( Site 0154)

    Liaocheng, Shandong, 252000

  • People s Hospital of Lishui City ( Site 0137)

    Lishui, Zhejiang, 323000

  • Jiangxi Provincial People's Hospital ( Site 0129)

    Nanchang, Jiangxi, 330006

  • The First Affiliated Hospital of Nanchang University ( Site 0132)

    Nanchang, Jiangxi, 330006

  • The Second Affiliated Hospital of Nanchang University-Neurosurgery Department ( Site 0151)

    Nanchang, Jiangxi, 330006

  • The first people s hospital of Nanning ( Site 0138)

    Nanning, Guangxi, 530022

  • The first people s hospital of Nanning ( Site 0141)

    Nanning, Guangxi, 530022

  • Ningbo First Hospital-neurosurgery ( Site 0152)

    Ningbo, Zhejiang, 315010

  • Ruijin Hospital Shanghai Jiao Tong University School of Medicine ( Site 0104)

    Shanghai, Shanghai Municipality, 200025

  • Huadong Hospital Affiliated Fudan University ( Site 0103)

    Shanghai, Shanghai Municipality, 200040

  • Huashan Hospital of Fudan University ( Site 0105)

    Shanghai, Shanghai Municipality, 200040

  • Shanghai General Hospital ( Site 0125)

    Shanghai, Shanghai Municipality, 200080

  • Shanghai Pulmonary Hospital ( Site 0108)

    Shanghai, Shanghai Municipality, 200443

  • The First Affiliated Hospital of China Medical University ( Site 0116)

    Shenyang, Liaoning, 110001

  • Shenzhen People s Hospital ( Site 0134)

    Shenzhen, Guangdong, 518020

  • Shiyan City People's Hospital-Neurosurgery ( Site 0155)

    Shiyan, Hubei, 442000

  • First Hospital Affiliated to Suzhou University ( Site 0111)

    Suzhou, Jiangsu, 215008

  • Tianjin Medical University General Hospital ( Site 0113)

    Tianjin, Tianjin Municipality, 300052

  • The 2nd Affiliated Hospital of Wenzhou Medical University ( Site 0130)

    Wenzhou, Zhejiang, 325000

  • Wuxi People's Hospital ( Site 0124)

    Wuxi, Jiangsu, 214023

  • Zhongshan Hospital Affiliated to Xiamen University ( Site 0133)

    Xiamen, Fujian, 361004

  • General Hospital of Ningxia Medical University ( Site 0135)

    Yinchuan, Ningxia, 750004

  • Zhangzhou Municipal Hospital of Fujian Province-Neurosurgery Department ( Site 0150)

    Zhangzhou, Fujian, 363000

  • The First Affiliated Hospital of Zhengzhou University ( Site 0121)

    Zhengzhou, Henan, 450052

  • Affiliated Hospital of Jiangsu University ( Site 0147)

    Zhenjiang, Jiangsu, 212000

Other trials in China

Russia5 sites

  • First City Clinical Hospital n.a. E.E.Volosevich ( Site 1016)

    Arkhangelsk, Arkhangelskaya oblast, 163001

  • Research Institute of Emergency Medicine n.a. I.I.Dzhanelidze ( Site 1011)

    Saint Petersburg, Sankt-Peterburg, 192242

  • Clinical Hospital #122 L.G. Sokolova FMBA ( Site 1015)

    Saint Petersburg, Sankt-Peterburg, 194291

  • City Hospital #26 ( Site 1002)

    Saint Petersburg, Sankt-Peterburg, 196247

  • City Hospital #2 Severodvinsk ( Site 1017)

    Severodvinsk, Arkhangelskaya oblast, 164500

Other trials in Russia

Ukraine5 sites

  • ME Dnipropetrovsk Clinical Joinder of Emergency Care of DRC ( Site 1304)

    Dnipro, Dnipropetrovsk Oblast, 49006

  • Ivano-Frankivsk regional clinical hospital ( Site 1301)

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76008

  • City Clinical Hospital No13 of Kharkiv City Council ( Site 1303)

    Kharkiv, Kharkiv Oblast, 61124

  • Kiyv city municipal hospital 17 ( Site 1300)

    Kiev, Kyivska Oblast, 01133

  • Reg. Clin. Hospital ( Site 1306)

    Poltava, Poltava Oblast, 36000

Other trials in Ukraine

France4 sites

  • Hopital Bicetre ( Site 0605)

    Le Kremlin-Bicêtre, Val-de-Marne, 94270

  • Hopital Roger Salengro du Lille ( Site 0601)

    Lille, Nord, 59037

  • CHU de Nantes - Hotel Dieu ( Site 0600)

    Nantes, Pays de la Loire Region, 44093

  • Hospices Civils de Lyon ( Site 0603)

    Pierre-Bénite, Rhone, 69495

Other trials in France

Philippines3 sites

  • West Visayas State University Medical Center ( Site 0900)

    Iloilo City, 5000

  • Mary Johnston Hospital ( Site 0901)

    Metro Manila, National Capital Region, 1012

  • Lung Center of the Philippines ( Site 0903)

    Quezon City, National Capital Region, 1104

Other trials in Philippines

Brazil2 sites

  • Santa Casa de Misericordia de Belo Horizonte ( Site 0300)

    Belo Horizonte, Minas Gerais, 30150-221

  • Hospital de Base de Sao Jose de Rio Preto ( Site 0301)

    Sao Jose Do Rio Preto - SP, São Paulo, 15090-000

Other trials in Brazil

Mexico2 sites

  • Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0800)

    Guadalajara, Jalisco, 44280

  • Hospital Civil Nuevo de Guadalajara Dr. Juan I. Menchaca ( Site 0804)

    Guadalajara, Jalisco, 44340

Other trials in Mexico

Romania2 sites

  • Spitalul Clinic de Urgenta Bagdasar-Arseni ( Site 1101)

    Bucharest, 041915

  • Spitalul Clinic Judetean de Urgenta Pius Branzeu ( Site 1103)

    Timișoara, Timiș County, 300723

Other trials in Romania

About this study

Official title: A Multi-national Phase 3, 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 will evaluate the efficacy and safety of a FDC of imipenem/cilastatin (IMI) and relebactam (REL) [IMI/REL, MK-7655A] compared to piperacillin/tazobactam (PIP/TAZ) in the treatment of adults diagnosed with Hospital-Acquired Bacterial Pneumonia (HABP) or Ventilator-Associated Bacterial Pneumonia (VABP). The primary hypothesis is that IMI/REL is non-inferior to PIP/TAZ as measured by the incidence rate of all-cause mortality through Day 28 post-randomization.

Being tested
IMI/REL FDC, PIP/TAZ FDC, Linezolid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IMI/REL FDCDrug

    Also called MK-7655A

    500 mg Imipenem, 500 mg Cilastatin and 250 mg Relebactam powder FDC provided in a single vial

  • PIP/TAZ FDCDrug

    4000 mg Piperacillin and 500 mg Tazobactam powder FDC provided in a single vial

  • LinezolidDrug

    Open-label 600 mg Linezolid

Study groups in NCT03583333
Study groupRoleWhat they receive
IMI/REL FDCExperimentalImipenem/cilastatin/relebactam (IMI/REL) administered intravenously (IV) as a fixed-dose combination (FDC) at a dosage of 500 mg IMI/250 mg REL, once every 6 hours for a minimum 7 days, up to 14 days. At the start of IMI/REL treatment, participants will be treated empirically with 600 mg open-label linezolid administered IV every 12 hours until methicillin-resistant Staphylococcus aureus (MRSA) is ruled out. Participants with confirmed MRSA infection will continue to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.
Receives: Drug: IMI/REL FDC; Drug: Linezolid
PIP/TAZ FDCActive comparatorPiperacillin/tazobactam (PIP/TAZ ) administered IV as a FDC at a dosage of 4000 mg PIP/500 mg TAZ once every 6 hours for a minimum 7 days, up to 14 days. At the start of PIP/TAZ treatment, participants will be treated empirically with 600 mg open-label linezolid administered IV every 12 hours until methicillin-resistant Staphylococcus aureus (MRSA) is ruled out. Participants with confirmed MRSA infection will continue to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.
Receives: Drug: PIP/TAZ FDC; Drug: Linezolid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With All-cause Mortality Through Day 28 in the Modified Intent to Treat (MITT) Population

    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.

    Measured: Up to approximately 28 days

Secondary outcomes (9)

  1. Percentage of Participants Achieving a Favorable Clinical Response at Early Follow-up (EFU) Visit in the MITT Population

    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.

    Measured: Up to approximately 27 days

  2. Percentage of Participants Achieving a Favorable Clinical Response at EFU Visit in the Clinically Evaluable (CE) Population

    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.

    Measured: Up to approximately 27 days

  3. Percentage of Participants Achieving a Favorable Clinical Response at End of Therapy (EOT) Visit in the MITT Population

    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.

    Measured: Up to approximately 14 days

  4. Percentage of Participants Achieving a Favorable Clinical Response at EOT Visit in the Clinically Evaluable (CE) Population

    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.

    Measured: Up to approximately 14 days

  5. Percentage of Participants Achieving a Favorable Microbiological Response at EOT Visit in Microbiological Modified Intent-To-Treat Population (mMITT) Population

    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.

    Measured: Up to approximately 14 days

  6. Percentage of Participants Achieving a Favorable Microbiological Response at EFU Visit in Microbiological-evaluable (ME) Population.

    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.

    Measured: Up to approximately 27 days

  7. Percentage of Participants Achieving a Favorable Microbiological Response at EOT Visit in the ME Population

    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.

    Measured: Up to approximately 14 days

  8. Percentage of Participants Experiencing Adverse Events (AEs)

    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.

    Measured: Up to approximately 98 days

  9. Percentage of Participants Discontinuing Study Drug Due to AEs

    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.

    Measured: Up to approximately 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2018
  2. Study start18 Sep 2018
  3. Primary completion12 Jul 2022
  4. Study completion12 Jul 2022

Resources

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
274 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03583333
Sponsor's protocol ID
7655A-016
Other IDs
MK-7655A-016, PHRR190814-002177, 2018-003202-82, 2018
Status last verified
Jan 2025
First submitted
28 Jun 2018
Last updated
29 Jan 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

  • Li J, Wei F, Xiang P, Tang Z, Ding L, Chen LF, Losada M, Iamboliyska Z, Sun F, Zhu M, Guo X, Du X, Chen C, Bruno C, Koseoglu S, Young K, Zhou M, Qu J. A phase III, randomized, controlled noninferiority trial to study the efficacy and safety of imipenem/cilastatin/relebactam (IMI/REL) vs piperacillin/tazobactam (PIP/TAZ) in patients with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP). Int J Infect Dis. 2025 Apr;153:107357. doi: 10.1016/j.ijid.2024.107357. Epub 2024 Dec 12.

    PubMed 39674398

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing IMI/REL FDC, PIP/TAZ FDC and Linezolid in people with Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia, run by Merck Sharp & Dohme LLC at 68 sites in 8 countries.

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 8 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 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in China, Russia, Ukraine, France, Philippines and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

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 28 Jun 2023). 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 Through Day 28 in the Modified Intent to Treat (MITT) Population (time frame: Up to approximately 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 NCT03583333, which also lists 1 linked publication.

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 29 Jan 2025.

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