Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
Conditions
Brief summary
This phase II trial studies the effect of imipenem-relebactam in treating patients with cancer who have a fever due to low white blood cell counts (febrile neutropenia). In this study, imipenem-relebactam will be compared to the standard-of-care treatment (cefepime, meropenem, or piperacillin/tazobactam) for the treatment of febrile neutropenia. Imipenem-relebactam is used to treat infections. Giving imipenem-relebactam may help to control febrile neutropenia in patients with cancer.
Detailed description
PRIMARY OBJECTIVES: I. To evaluate the safety and tolerability of imipenem-relebactam plus vancomycin, daptomycin, or linezolid compared with SOC plus vancomycin, daptomycin or linezolid as empiric therapy in febrile neutropenic adults with cancer. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I (TREATMENT): Patients receive imipenem/cilastatin/relebactam IV over 30-60 minutes once every 6 hours (q6h) for 2 days for a minimum of 8 doses. Patients may also receive gram-positive therapy at the discretion of the primary team or emergency center physician consisting of vancomycin IV q12h or linezolid IV or orally (PO) q12h. Patients may continue to receive imipenem/cilastatin/relebactam IV over 30-60 minutes for up to 14 days if clinically indicated by the assessment of the treating physician. GROUP II (STANDARD OF CARE): Patients receive cefepime IV q8h for a minimum of 6 doses, meropenem IV q8h for a minimum of 6 doses, or piperacillin/tazobactam IV q6h for a minimum of 8 doses. Patients may also receive gram-positive therapy at the discretion of the primary team or emergency center physician consisting of vancomycin IV q12h or linezolid IV or PO q12h. Patients in both groups may receive other additional therapy (double-gram negative therapy) consisting of tobramycin IV q24h, amikacin IV q24h, ciprofloxacin IV q8h, minocycline q12h, tigecycline on days 1-2 q12h, doxycycline q12h, and/or bactrim. After at least 48 hours of gram-negative antimicrobial therapy, patients may be allowed to switch to PO or IV therapy such as linezolid PO, ampicillin, amoxicillin, amoxicillin/clavulanate PO, minocycline PO, ciprofloxacin PO, levofloxacin PO, cefpodoxime PO, trimethoprim/sulfamethoxazole PO, ceftriaxone IV, ertapenem IV, daptomycin IV and/or vancomycin IV for outpatient or home administration as clinically indicated. While in the hospital, patients undergo the collection of blood samples daily for 2 weeks, and urine samples every 2 days for up to 2 weeks. After completion of study treatment, patients are followed up at 2, 21-28, and 35-42 days.
Interventions
Given IV
DRUGCefepime
Given IV
DRUGMeropenem
Given IV
Given IV
DRUGVancomycin
Given IV
DRUGDaptomycin
Given IV
DRUGLinezolid
Given IV or PO
Sponsors
Merck Sharp & Dohme LLC
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Has provided written informed consent, and has the willingness and ability to comply with all study procedures * \>= 18 years old * Patients with neutropenic fever who have existing malignancy or have undergone hematopoietic stem cell transplantation * Neutropenic fever is defined as the presence of neutropenia defined by: * Absolute neutrophil count (ANC) \< 500 cells/mm3 or has an ANC that is expected to decrease to \< 500 cells/mm\^3 within 48 hours of trial entry and fever defined as: * Single oral temperature measurement of \> 100.4 degree F (38.0 degree C). * Requires hospitalization for IV empiric antibiotic therapy * If female: * Not breastfeeding * Agrees to not attempt to become pregnant during the study. Is surgically sterile or at least 2-years postmenopausal, or if of childbearing potential, has negative screening serum or urine pregnancy test within 5 days * If of childbearing potential (including being \< 2 years postmenopausal), is willing to practice sexual abstinence or use an effective dual form of contraception with her partner (eg, 2 barrier methods, barrier method plus hormonal method) during treatment and up 28 days post treatment
Exclusion criteria
* History of any hypersensitivity or allergic reaction to any carbapenem * Fever suspected to be caused by a noninfectious cause (eg, fever related to drug or blood product administration) * Confirmed fungal infection (eg, Pneumocystis jirovecii etiology in patients with pneumonia) that justifies adding additional empiric antimicrobial therapy (eg, antifungals) * Confirmed viral infection that justifies adding additional empiric antiviral therapy (eg, ganciclovir, foscarnet) * Evidence of significant hepatic impairment (any of the following): * Known acute viral hepatitis * Alanine aminotransferase (ALT) level \> 5 times the upper limit of normal (x upper limit of normal \[ULN\]). Total bilirubin \> 3 x ULN unless isolated hyperbilirubinemia is directly related to the acute infection or due to known Gilbert disease * Manifestations of end-stage liver disease, such as ascites or hepatic encephalopathy * Known to be human immunodeficiency virus positive * Severely impaired renal function, defined as creatinine clearance (CrCl) =\< 30 mL/min estimated by the Cockcroft-Gault formula * Expected requirement for hemodialysis while on study therapy * Received \> 36 hours of IV antibacterial therapy (with study drugs) within 72 hours of the initiation of inpatient IV study drug for treatment of suspected infection. Antibiotic prophylaxis and oral antibiotics is allowed. Prophylactic use of antiviral or antifungal medication is permitted * Past or current history of epilepsy or seizure disorder; exception: well-documented febrile seizure of childhood * Evidence of immediately life-threatening disease, progressively fatal disease, or life expectancy of 3 months or less (eg, moribund or with shock unresponsive to fluid replacement) * Unable or unwilling to adhere to the study-specified procedures and restrictions * Any condition that would make the patient, in the opinion of the Investigator, unsuitable for the study (eg, would place a patient at risk or compromise the quality of the data * Participation in any other ongoing imipenem-relebactam trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Outcome in the MITT Analysis Set at EOIV. | Within 72 hours after administration of the last dose of inpatient IV study drug. | The primary efficacy outcome is favorable clinical response of the patients in the MITT (Modified Intent-To-Treat) Analysis Set at end of inpatient intravenous therapy (EOIV). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Outcome in the CE Analysis Set at LFU. | 35 to 42 days after the start of inpatient IV study drug. | The secondary efficacy outcome is favorable clinical response of the patients in the CE (Clinically Evaluable) Analysis Set at late follow-up (LFU). The clinical outcome has three categories: Clinical cure, Clinical failure, and Indeterminate. |
| Clinical Outcome in the ME Analysis Set at EOIV. | Within 72 hours after administration of the last dose of inpatient IV study drug. | The secondary efficacy outcome is favorable clinical response of the patients in the ME (Microbiologically Evaluable) Analysis Set at end of inpatient intravenous therapy (EOIV). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate. |
| Clinical Outcome in the mMITT Analysis Set at EOIV. | Within 72 hours after administration of the last dose of inpatient IV study drug. | The secondary efficacy outcome is favorable clinical response of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at end of inpatient intravenous therapy (EOIV). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate. |
| Clinical Outcome in the CE Analysis Set at EOIV. | Within 72 hours after administration of the last dose of inpatient IV study drug. | The secondary efficacy outcome is favorable clinical response of the patients in the CE (Clinically Evaluable) Analysis Set at end of inpatient intravenous therapy (EOIV). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate. |
| Clinical Outcome in the MITT Analysis Set at TOC. | 21 to 28 days after the start of inpatient IV study drug. | The secondary efficacy outcome is favorable clinical response of the patients in the MITT (Modified Intent-To-Treat) Analysis Set at test-of-cure (TOC). The clinical outcome has three categories: Clinical cure, Clinical failure, and Indeterminate. |
| Clinical Outcome in the MITT Analysis Set at LFU. | 35 to 42 days after the start of inpatient IV study drug. | The secondary efficacy outcome is favorable clinical response of the patients in the MITT (Modified Intent-To-Treat) Analysis Set at late follow-up (LFU). The clinical outcome has three categories: Clinical cure, Clinical failure, and Indeterminate. |
| Clinical Outcome in the mMITT Analysis Set at TOC. | 21 to 28 days after the start of inpatient IV study drug. | The secondary efficacy outcome is favorable clinical response of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at test-of-cure (TOC). The clinical outcome has three categories: Clinical cure, Clinical failure, and Indeterminate. |
| Clinical Outcome in the mMITT Analysis Set at LFU. | Pateints in mMITT (Microbiological Modified Intent-To-Treat) Analysis Set | The secondary efficacy outcome is favorable clinical response of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at late follow-up (LFU). The clinical outcome has three categories: Clinical cure, Clinical failure, and Indeterminate. |
| Clinical Outcome in the CE Analysis Set at TOC. | 21 to 28 days after the start of inpatient IV study drug. | The secondary efficacy outcome is favorable clinical response of the patients in the CE (Clinically Evaluable) Analysis Set at test-of-cure (TOC). The clinical outcome has three categories: Clinical cure, Clinical failure, and Indeterminate. |
| Clinical Outcome in the ME Analysis Set at TOC. | 21 to 28 days after the start of inpatient IV study drug. | The secondary efficacy outcome is favorable clinical response of the patients in the ME (Microbiologically Evaluable) Analysis Set at test-of-cure (TOC). The clinical outcome has three categories: Clinical cure, Clinical failure, and Indeterminate. |
| Clinical Outcome in the ME Analysis Set at LFU. | 35 to 42 days after the start of inpatient IV study drug. | The secondary efficacy outcome is favorable clinical response of the patients in the ME (Microbiologically Evaluable) Analysis Set at late follow-up (LFU). The clinical outcome has three categories: Clinical cure, Clinical failure, and Indeterminate. |
| Microbiological Outcome in the mMITT Analysis Set at EOIV. | Within 72 hours after administration of the last dose of inpatient IV study drug. | The secondary efficacy outcome is favorable microbiological response of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at end of inpatient intravenous therapy (EOIV). The microbiological response outcome has five categories: Persistence, eradication, presumed eradication, presumed persistence, and Indeterminate. |
| Microbiological Outcome in the mMITT Analysis Set at TOC. | 21 to 28 days after the start of inpatient IV study drug. | The secondary efficacy outcome is favorable microbiological response of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at test-of-cure (TOC). The microbiological response outcome has five categories: Persistence, eradication, presumed eradication, presumed persistence, and Indeterminate. |
| Microbiological Outcome in the mMITT Analysis Set at LFU. | 35 to 42 days after the start of inpatient IV study drug. | The secondary efficacy outcome is favorable microbiological response of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at late follow-up (LFU). The microbiological response outcome has five categories: Persistence, eradication, presumed eradication, presumed persistence, and Indeterminate. |
| Microbiological Outcome in the ME Analysis Set at EOIV. | Within 72 hours after administration of the last dose of inpatient IV study drug. | The secondary efficacy outcome is favorable microbiological response of the patients in the ME (Microbiologically Evaluable) Analysis Set at end of inpatient intravenous therapy (EOIV). The microbiological response outcome has five categories: Persistence, eradication, presumed eradication, presumed persistence, and Indeterminate. |
| Microbiological Outcome in the ME Analysis Set at TOC. | 21 to 28 days after the start of inpatient IV study drug. | The secondary efficacy outcome is favorable microbiological response of the patients in the ME (Microbiologically Evaluable) Analysis Set at test-of-cure (TOC). The microbiological response outcome has five categories: Persistence, eradication, presumed eradication, presumed persistence, and Indeterminate. |
| Microbiological Outcome in the ME Analysis Set at LFU. | 35 to 42 days after the start of inpatient IV study drug. | The secondary efficacy outcome is favorable microbiological response of the participants in the ME (Microbiologically Evaluable) Analysis Set at late follow-up (LFU). The microbiological response outcome has five categories: Persistence, eradication, presumed eradication, presumed persistence, and Indeterminate. |
| Infection-related Mortality in the MITT Analysis Set at TOC. | 21 to 28 days after the start of inpatient IV study drug. | The secondary efficacy outcome is infection-related mortality of the patients in the MITT (Modified Intent-To-Treat) Analysis Set at test-of-cure (TOC). |
| Infection-related Mortality in the MITT Analysis Set at LFU. | 35 to 42 days after the start of inpatient IV study drug. | The secondary efficacy outcome is infection-related mortality of the patients in the MITT (Modified Intent-To-Treat) Analysis Set at late follow-up (LFU). |
| Infection-related Mortality in the mMITT Analysis Set at TOC. | 21 to 28 days after the start of inpatient IV study drug. | The secondary efficacy outcome is Infection-related mortality of the participants in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at test-of-cure (TOC). |
| Infection-related Mortality in the mMITT Analysis Set at LFU. | 35 to 42 days after the start of inpatient IV study drug. | The secondary efficacy outcome is Infection-related mortality of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at late follow-up (LFU). |
| 30-Day All-cause Mortality in the MITT Analysis Set. | 30 days after the last dose of inpatient IV study drug. | The secondary efficacy outcome is 30-day all-cause mortality of the patients in the MITT (Modified Intent-To-Treat) Analysis Set. |
| 30-Day All-cause Mortality in the mMITT Analysis Set. | 30 days after the last dose of inpatient IV study drug. | The secondary efficacy outcome is 30-day all-cause mortality of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set. |
Countries
United States
Participant flow
Recruitment details
Between September 14, 2021 and October 06, 2023, patients presenting to the emergency medicine department were screened through an EPIC generated list identifying patients with fever and neutropenia that meet the inclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| Imipenem-Relebactam Arm Patients receive imipenem/cilastatin/relebactam IV over 30-60 minutes once every 6 hours (q6h) for 2 days for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or orally (PO) q12h. Daptomycion could be given if no pneumonia. Participants may continue on the study drug for up to 14 days. Participants may receive other addtional therapy. | 49 |
| Standard of Care (SOC) Arm Patients receive cefepime IV q8h for a minimum of 6 doses, or meropenem IV q8h for a minimum of 6 doses, or piperacillin/tazobactam IV q6h for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or orally (PO) q12h. Daptomycion could be given if no pneumonia. Patients may receive other additional therapy. | 50 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 4 |
| Overall Study | Lost to Follow-up | 3 | 0 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Total | Standard of Care (SOC) Arm | Imipenem-Relebactam Arm |
|---|---|---|---|
| Age, Continuous | 61 years | 63 years | 55 years |
| Antibiotics for gram positive coverage Daptomycin | 4 Participants | 1 Participants | 3 Participants |
| Antibiotics for gram positive coverage Linezolid | 45 Participants | 27 Participants | 18 Participants |
| Antibiotics for gram positive coverage Linezolid & daptomycin | 1 Participants | 0 Participants | 1 Participants |
| Antibiotics for gram positive coverage None | 9 Participants | 2 Participants | 7 Participants |
| Antibiotics for gram positive coverage Vancomycin | 40 Participants | 20 Participants | 20 Participants |
| Bacteremia | 28 Participants | 15 Participants | 13 Participants |
| Clinical source presentation | 51 Participants | 25 Participants | 26 Participants |
| CVC being the source of BSI isolation | 23 Participants | 11 Participants | 12 Participants |
| Gram positive coverage with any of the above antibiotics | 90 Participants | 48 Participants | 42 Participants |
| History of BMT within one year Allogeniec | 6 Participants | 3 Participants | 3 Participants |
| History of BMT within one year Autologous | 3 Participants | 3 Participants | 0 Participants |
| History of BMT within one year History of BMT within one year | 9 Participants | 6 Participants | 3 Participants |
| ICU admission | 5 Participants | 2 Participants | 3 Participants |
| Mechanical ventilation | 1 Participants | 0 Participants | 1 Participants |
| Microbiological documentation (positivity) | 30 Participants | 17 Participants | 13 Participants |
| Neurologic impairment Confusion | 1 Participants | 0 Participants | 1 Participants |
| Neurologic impairment Neurologic impairment | 1 Participants | 0 Participants | 1 Participants |
| Organisms identified Both Gram Positive and Gram Negative | 4 Participants | 4 Participants | 0 Participants |
| Organisms identified Gram negative | 15 Participants | 8 Participants | 7 Participants |
| Organisms identified Gram positive | 11 Participants | 5 Participants | 6 Participants |
| Organisms identified Organisms identified | 30 Participants | 17 Participants | 13 Participants |
| Organisms recovered in positive cultures Enterobacter cloacae | 3 Participants | 1 Participants | 2 Participants |
| Organisms recovered in positive cultures Enterococcus faecalis & Rothia mucilaginosa | 1 Participants | 0 Participants | 1 Participants |
| Organisms recovered in positive cultures Enterococcus faecium | 1 Participants | 1 Participants | 0 Participants |
| Organisms recovered in positive cultures Escherichia coli | 6 Participants | 3 Participants | 3 Participants |
| Organisms recovered in positive cultures Haemophilus parainfluenzae & Streptococcus mitis/oralis Group | 1 Participants | 1 Participants | 0 Participants |
| Organisms recovered in positive cultures Klebsiella pneumoniae | 2 Participants | 2 Participants | 0 Participants |
| Organisms recovered in positive cultures Klebsiella pneumoniae & Enterococcus faecalis | 1 Participants | 1 Participants | 0 Participants |
| Organisms recovered in positive cultures Organisms recovered in positive cultures | 30 Participants | 17 Participants | 13 Participants |
| Organisms recovered in positive cultures Pseudomonas aeruginosa | 3 Participants | 2 Participants | 1 Participants |
| Organisms recovered in positive cultures Pseudomonas aeruginosa, Streptococcus mitis/oralis Group & Enterococcus faecalis | 1 Participants | 1 Participants | 0 Participants |
| Organisms recovered in positive cultures Rhizobium radiobacter | 1 Participants | 0 Participants | 1 Participants |
| Organisms recovered in positive cultures Roseomonas mucosa, Micrococcus luteus & Dermacoccus nishinomiyaensis | 1 Participants | 1 Participants | 0 Participants |
| Organisms recovered in positive cultures Staphylococcus epidermidis | 3 Participants | 2 Participants | 1 Participants |
| Organisms recovered in positive cultures Streptococcus mitis/oralis group | 6 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Asian | 4 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Black or African American | 9 Participants | 5 Participants | 4 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 12 Participants | 4 Participants | 8 Participants |
| Race/Ethnicity, Customized Middle East | 2 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Others | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 71 Participants | 38 Participants | 33 Participants |
| Region of Enrollment United States | 99 participants | 50 participants | 49 participants |
| Sepsis status No sepsis | 70 Participants | 35 Participants | 35 Participants |
| Sepsis status Sepsis | 28 Participants | 14 Participants | 14 Participants |
| Sepsis status Severe sepsis | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Female | 46 Participants | 23 Participants | 23 Participants |
| Sex: Female, Male Male | 53 Participants | 27 Participants | 26 Participants |
| Site of clinical presentation Abdomen | 11 Participants | 4 Participants | 7 Participants |
| Site of clinical presentation Genitourinary | 3 Participants | 2 Participants | 1 Participants |
| Site of clinical presentation Head and neck | 1 Participants | 0 Participants | 1 Participants |
| Site of clinical presentation Lung (pneumonia) | 37 Participants | 19 Participants | 18 Participants |
| Site of clinical presentation Skin and soft tissue | 2 Participants | 1 Participants | 1 Participants |
| Site of organism Blood | 28 Participants | 15 Participants | 13 Participants |
| Site of organism Genitourinary | 2 Participants | 2 Participants | 0 Participants |
| SOC Antibiotics Cefepime | 43 Participants | 43 Participants | 0 Participants |
| SOC Antibiotics Meropenem | 2 Participants | 2 Participants | 0 Participants |
| SOC Antibiotics Piperacillin/tazobactam | 5 Participants | 5 Participants | 0 Participants |
| Temperature at initial presentation (oC) < 36 | 0 Participants | 0 Participants | 0 Participants |
| Temperature at initial presentation (oC) 36-38 | 0 Participants | 0 Participants | 0 Participants |
| Temperature at initial presentation (oC) > 38 | 99 Participants | 50 Participants | 49 Participants |
| Type of allogeneic transplant GVHD | 4 Participants | 2 Participants | 2 Participants |
| Type of allogeneic transplant HLA matched related | 1 Participants | 0 Participants | 1 Participants |
| Type of allogeneic transplant Matched unrelated donor | 4 Participants | 2 Participants | 2 Participants |
| Type of allogeneic transplant Others | 1 Participants | 1 Participants | 0 Participants |
| Type of Cancer Hematological malignancy | 64 Participants | 31 Participants | 33 Participants |
| Type of Cancer Solid tumor | 35 Participants | 19 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 49 | 4 / 50 |
| other Total, other adverse events | 4 / 49 | 7 / 50 |
| serious Total, serious adverse events | 30 / 49 | 29 / 50 |
Outcome results
Primary
Clinical Outcome in the MITT Analysis Set at EOIV.
The primary efficacy outcome is favorable clinical response of the patients in the MITT (Modified Intent-To-Treat) Analysis Set at end of inpatient intravenous therapy (EOIV). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate.
Time frame: Within 72 hours after administration of the last dose of inpatient IV study drug.
Population: Patients in MITT (Modified Intent-To-Treat) Analysis Set The MITT Analysis Set will be a subset of the ITT Analysis Set and will include all randomized patients who received any amount of inpatient IV study drug and meet minimal disease criteria (Inclusion Criterion 3). Patients will be analyzed according to randomized treatment group, regardless of treatment received.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Imipenem-Relebactam Arm | Clinical Outcome in the MITT Analysis Set at EOIV. | Favorable clinical resposne | 44 Participants |
| Imipenem-Relebactam Arm | Clinical Outcome in the MITT Analysis Set at EOIV. | Clinical failure | 5 Participants |
| Imipenem-Relebactam Arm | Clinical Outcome in the MITT Analysis Set at EOIV. | Indeterminate | 0 Participants |
| Standard of Care (SOC) Arm | Clinical Outcome in the MITT Analysis Set at EOIV. | Favorable clinical resposne | 37 Participants |
| Standard of Care (SOC) Arm | Clinical Outcome in the MITT Analysis Set at EOIV. | Clinical failure | 12 Participants |
| Standard of Care (SOC) Arm | Clinical Outcome in the MITT Analysis Set at EOIV. | Indeterminate | 1 Participants |
Secondary
30-Day All-cause Mortality in the MITT Analysis Set.
The secondary efficacy outcome is 30-day all-cause mortality of the patients in the MITT (Modified Intent-To-Treat) Analysis Set.
Time frame: 30 days after the last dose of inpatient IV study drug.
Population: Patients in MITT (Modified Intent-To-Treat) Analysis Set The MITT Analysis Set will be a subset of the ITT Analysis Set and will include all randomized patients who received any amount of inpatient IV study drug and meet minimal disease criteria (Inclusion Criterion 3). Patients will be analyzed according to randomized treatment group, regardless of treatment received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Imipenem-Relebactam Arm | 30-Day All-cause Mortality in the MITT Analysis Set. | 2 Participants |
| Standard of Care (SOC) Arm | 30-Day All-cause Mortality in the MITT Analysis Set. | 3 Participants |
Secondary
30-Day All-cause Mortality in the mMITT Analysis Set.
The secondary efficacy outcome is 30-day all-cause mortality of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set.
Time frame: 30 days after the last dose of inpatient IV study drug.
Population: Patients in MITT (Modified Intent-To-Treat) Analysis Set The mMITT Analysis Set will be a subset of the MITT Analysis Set and will include those patients for whom at least 1 qualifying bacterial pathogen was isolated from an appropriate microbiological specimen at baseline, irrespective of susceptibility to study therapies.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Imipenem-Relebactam Arm | 30-Day All-cause Mortality in the mMITT Analysis Set. | 0 Participants |
| Standard of Care (SOC) Arm | 30-Day All-cause Mortality in the mMITT Analysis Set. | 0 Participants |
Secondary
Clinical Outcome in the CE Analysis Set at EOIV.
The secondary efficacy outcome is favorable clinical response of the patients in the CE (Clinically Evaluable) Analysis Set at end of inpatient intravenous therapy (EOIV). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate.
Time frame: Within 72 hours after administration of the last dose of inpatient IV study drug.
Population: Patients in CE (Clinically Evaluable) Analysis Set - A subset of the MITT Analysis Set including patients with the following conditions:~Received \>=48 hrs of IV study drug to be considered an evaluable clinical failure, unless deemed a clinical failure based on a treatment-limiting AE Received \>=48 hrs of IV gram negative coverage to be considered an evaluable clinical cure Had clinical outcome assessment at TOC (other than indeterminate) or assessed as clinical failure at EOIV or TOC
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Imipenem-Relebactam Arm | Clinical Outcome in the CE Analysis Set at EOIV. | Favorable clinical resposne | 37 Participants |
| Imipenem-Relebactam Arm | Clinical Outcome in the CE Analysis Set at EOIV. | Clinical failure | 5 Participants |
| Standard of Care (SOC) Arm | Clinical Outcome in the CE Analysis Set at EOIV. | Favorable clinical resposne | 26 Participants |
| Standard of Care (SOC) Arm | Clinical Outcome in the CE Analysis Set at EOIV. | Clinical failure | 9 Participants |
Secondary
Clinical Outcome in the CE Analysis Set at LFU.
The secondary efficacy outcome is favorable clinical response of the patients in the CE (Clinically Evaluable) Analysis Set at late follow-up (LFU). The clinical outcome has three categories: Clinical cure, Clinical failure, and Indeterminate.
Time frame: 35 to 42 days after the start of inpatient IV study drug.
Population: Patients in CE (Clinically Evaluable) Analysis Set - A subset of the MITT Analysis Set including patients with the following conditions:~Received \>=48 hrs of IV study drug to be considered an evaluable clinical failure, unless deemed a clinical failure based on a treatment-limiting AE Received \>=48 hrs of IV gram negative coverage to be considered an evaluable clinical cure Had clinical outcome assessment at TOC (other than indeterminate) or assessed as clinical failure at EOIV or TOC
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Imipenem-Relebactam Arm | Clinical Outcome in the CE Analysis Set at LFU. | Clinical failure | 8 Participants |
| Imipenem-Relebactam Arm | Clinical Outcome in the CE Analysis Set at LFU. | Clinical cure | 32 Participants |
| Imipenem-Relebactam Arm | Clinical Outcome in the CE Analysis Set at LFU. | Indeterminate | 2 Participants |
| Standard of Care (SOC) Arm | Clinical Outcome in the CE Analysis Set at LFU. | Clinical failure | 10 Participants |
| Standard of Care (SOC) Arm | Clinical Outcome in the CE Analysis Set at LFU. | Clinical cure | 23 Participants |
| Standard of Care (SOC) Arm | Clinical Outcome in the CE Analysis Set at LFU. | Indeterminate | 2 Participants |
Secondary
Clinical Outcome in the CE Analysis Set at TOC.
The secondary efficacy outcome is favorable clinical response of the patients in the CE (Clinically Evaluable) Analysis Set at test-of-cure (TOC). The clinical outcome has three categories: Clinical cure, Clinical failure, and Indeterminate.
Time frame: 21 to 28 days after the start of inpatient IV study drug.
Population: Patients in CE (Clinically Evaluable) Analysis Set - A subset of the MITT Analysis Set including patients with the following conditions:~Received \>=48 hrs of IV study drug to be considered an evaluable clinical failure, unless deemed a clinical failure based on a treatment-limiting AE Received \>=48 hrs of IV gram negative coverage to be considered an evaluable clinical cure Had clinical outcome assessment at TOC (other than indeterminate) or assessed as clinical failure at EOIV or TOC
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Imipenem-Relebactam Arm | Clinical Outcome in the CE Analysis Set at TOC. | Clinical cure | 34 Participants |
| Imipenem-Relebactam Arm | Clinical Outcome in the CE Analysis Set at TOC. | Clinical failure | 8 Participants |
| Standard of Care (SOC) Arm | Clinical Outcome in the CE Analysis Set at TOC. | Clinical cure | 25 Participants |
| Standard of Care (SOC) Arm | Clinical Outcome in the CE Analysis Set at TOC. | Clinical failure | 10 Participants |
Secondary
Clinical Outcome in the ME Analysis Set at EOIV.
The secondary efficacy outcome is favorable clinical response of the patients in the ME (Microbiologically Evaluable) Analysis Set at end of inpatient intravenous therapy (EOIV). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate.
Time frame: Within 72 hours after administration of the last dose of inpatient IV study drug.
Population: Patients in ME (Microbiologically Evaluable) Analysis Set The ME Analysis Set will include patients who meet the criteria for both the CE and mMITT analysis sets.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Imipenem-Relebactam Arm | Clinical Outcome in the ME Analysis Set at EOIV. | Favorable clinical resposne | 4 Participants |
| Imipenem-Relebactam Arm | Clinical Outcome in the ME Analysis Set at EOIV. | Clinical failure | 1 Participants |
| Standard of Care (SOC) Arm | Clinical Outcome in the ME Analysis Set at EOIV. | Clinical failure | 1 Participants |
| Standard of Care (SOC) Arm | Clinical Outcome in the ME Analysis Set at EOIV. | Favorable clinical resposne | 6 Participants |
Secondary
Clinical Outcome in the ME Analysis Set at LFU.
The secondary efficacy outcome is favorable clinical response of the patients in the ME (Microbiologically Evaluable) Analysis Set at late follow-up (LFU). The clinical outcome has three categories: Clinical cure, Clinical failure, and Indeterminate.
Time frame: 35 to 42 days after the start of inpatient IV study drug.
Population: Patients in ME (Microbiologically Evaluable) Analysis Set The ME Analysis Set will include patients who meet the criteria for both the CE and mMITT analysis sets.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Imipenem-Relebactam Arm | Clinical Outcome in the ME Analysis Set at LFU. | Clinical cure | 3 Participants |
| Imipenem-Relebactam Arm | Clinical Outcome in the ME Analysis Set at LFU. | Clinical failure | 2 Participants |
| Standard of Care (SOC) Arm | Clinical Outcome in the ME Analysis Set at LFU. | Clinical cure | 5 Participants |
| Standard of Care (SOC) Arm | Clinical Outcome in the ME Analysis Set at LFU. | Clinical failure | 2 Participants |
Secondary
Clinical Outcome in the ME Analysis Set at TOC.
The secondary efficacy outcome is favorable clinical response of the patients in the ME (Microbiologically Evaluable) Analysis Set at test-of-cure (TOC). The clinical outcome has three categories: Clinical cure, Clinical failure, and Indeterminate.
Time frame: 21 to 28 days after the start of inpatient IV study drug.
Population: Patients in ME (Microbiologically Evaluable) Analysis Set The ME Analysis Set will include patients who meet the criteria for both the CE and mMITT analysis sets.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Imipenem-Relebactam Arm | Clinical Outcome in the ME Analysis Set at TOC. | Clinical cure | 3 Participants |
| Imipenem-Relebactam Arm | Clinical Outcome in the ME Analysis Set at TOC. | Clinical failure | 2 Participants |
| Standard of Care (SOC) Arm | Clinical Outcome in the ME Analysis Set at TOC. | Clinical cure | 5 Participants |
| Standard of Care (SOC) Arm | Clinical Outcome in the ME Analysis Set at TOC. | Clinical failure | 2 Participants |
Secondary
Clinical Outcome in the MITT Analysis Set at LFU.
The secondary efficacy outcome is favorable clinical response of the patients in the MITT (Modified Intent-To-Treat) Analysis Set at late follow-up (LFU). The clinical outcome has three categories: Clinical cure, Clinical failure, and Indeterminate.
Time frame: 35 to 42 days after the start of inpatient IV study drug.
Population: Pateints in MITT (Modified Intent-To-Treat) Analysis Set The MITT Analysis Set will be a subset of the ITT Analysis Set and will include all randomized patients who received any amount of inpatient IV study drug and meet minimal disease criteria (Inclusion Criterion 3). Patients will be analyzed according to randomized treatment group, regardless of treatment received.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Imipenem-Relebactam Arm | Clinical Outcome in the MITT Analysis Set at LFU. | Indeterminate | 8 Participants |
| Imipenem-Relebactam Arm | Clinical Outcome in the MITT Analysis Set at LFU. | Clinical cure | 33 Participants |
| Imipenem-Relebactam Arm | Clinical Outcome in the MITT Analysis Set at LFU. | Clinical failure | 8 Participants |
| Standard of Care (SOC) Arm | Clinical Outcome in the MITT Analysis Set at LFU. | Clinical failure | 13 Participants |
| Standard of Care (SOC) Arm | Clinical Outcome in the MITT Analysis Set at LFU. | Indeterminate | 7 Participants |
| Standard of Care (SOC) Arm | Clinical Outcome in the MITT Analysis Set at LFU. | Clinical cure | 30 Participants |
Secondary
Clinical Outcome in the MITT Analysis Set at TOC.
The secondary efficacy outcome is favorable clinical response of the patients in the MITT (Modified Intent-To-Treat) Analysis Set at test-of-cure (TOC). The clinical outcome has three categories: Clinical cure, Clinical failure, and Indeterminate.
Time frame: 21 to 28 days after the start of inpatient IV study drug.
Population: Pateints in MITT (Modified Intent-To-Treat) Analysis Set The MITT Analysis Set will be a subset of the ITT Analysis Set and will include all randomized patients who received any amount of inpatient IV study drug and meet minimal disease criteria (Inclusion Criterion 3). Patients will be analyzed according to randomized treatment group, regardless of treatment received.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Imipenem-Relebactam Arm | Clinical Outcome in the MITT Analysis Set at TOC. | Clinical failure | 8 Participants |
| Imipenem-Relebactam Arm | Clinical Outcome in the MITT Analysis Set at TOC. | Clinical cure | 35 Participants |
| Imipenem-Relebactam Arm | Clinical Outcome in the MITT Analysis Set at TOC. | Indeterminate | 6 Participants |
| Standard of Care (SOC) Arm | Clinical Outcome in the MITT Analysis Set at TOC. | Clinical cure | 32 Participants |
| Standard of Care (SOC) Arm | Clinical Outcome in the MITT Analysis Set at TOC. | Clinical failure | 13 Participants |
| Standard of Care (SOC) Arm | Clinical Outcome in the MITT Analysis Set at TOC. | Indeterminate | 5 Participants |
Secondary
Clinical Outcome in the mMITT Analysis Set at EOIV.
The secondary efficacy outcome is favorable clinical response of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at end of inpatient intravenous therapy (EOIV). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate.
Time frame: Within 72 hours after administration of the last dose of inpatient IV study drug.
Population: Patients in mMITT (Microbiological Modified Intent-To-Treat) Analysis Set The mMITT Analysis Set will be a subset of the MITT Analysis Set and will include those patients for whom at least 1 qualifying bacterial pathogen was isolated from an appropriate microbiological specimen at baseline, irrespective of susceptibility to study therapies
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Imipenem-Relebactam Arm | Clinical Outcome in the mMITT Analysis Set at EOIV. | Favorable clinical resposne | 6 Participants |
| Imipenem-Relebactam Arm | Clinical Outcome in the mMITT Analysis Set at EOIV. | Clinical failure | 1 Participants |
| Imipenem-Relebactam Arm | Clinical Outcome in the mMITT Analysis Set at EOIV. | Indeterminate | 0 Participants |
| Standard of Care (SOC) Arm | Clinical Outcome in the mMITT Analysis Set at EOIV. | Favorable clinical resposne | 8 Participants |
| Standard of Care (SOC) Arm | Clinical Outcome in the mMITT Analysis Set at EOIV. | Clinical failure | 3 Participants |
| Standard of Care (SOC) Arm | Clinical Outcome in the mMITT Analysis Set at EOIV. | Indeterminate | 1 Participants |
Secondary
Clinical Outcome in the mMITT Analysis Set at LFU.
The secondary efficacy outcome is favorable clinical response of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at late follow-up (LFU). The clinical outcome has three categories: Clinical cure, Clinical failure, and Indeterminate.
Time frame: Pateints in mMITT (Microbiological Modified Intent-To-Treat) Analysis Set
Population: Patients in mMITT (Microbiological Modified Intent-To-Treat) Analysis Set The mMITT Analysis Set will be a subset of the MITT Analysis Set and will include those patients for whom at least 1 qualifying bacterial pathogen was isolated from an appropriate microbiological specimen at baseline, irrespective of susceptibility to study therapies.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Imipenem-Relebactam Arm | Clinical Outcome in the mMITT Analysis Set at LFU. | Clinical cure | 3 Participants |
| Imipenem-Relebactam Arm | Clinical Outcome in the mMITT Analysis Set at LFU. | Clinical failure | 2 Participants |
| Imipenem-Relebactam Arm | Clinical Outcome in the mMITT Analysis Set at LFU. | Indeterminate | 2 Participants |
| Standard of Care (SOC) Arm | Clinical Outcome in the mMITT Analysis Set at LFU. | Clinical cure | 6 Participants |
| Standard of Care (SOC) Arm | Clinical Outcome in the mMITT Analysis Set at LFU. | Clinical failure | 4 Participants |
| Standard of Care (SOC) Arm | Clinical Outcome in the mMITT Analysis Set at LFU. | Indeterminate | 2 Participants |
Secondary
Clinical Outcome in the mMITT Analysis Set at TOC.
The secondary efficacy outcome is favorable clinical response of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at test-of-cure (TOC). The clinical outcome has three categories: Clinical cure, Clinical failure, and Indeterminate.
Time frame: 21 to 28 days after the start of inpatient IV study drug.
Population: Patients in mMITT (Microbiological Modified Intent-To-Treat) Analysis Set The mMITT Analysis Set will be a subset of the MITT Analysis Set and will include those patients for whom at least 1 qualifying bacterial pathogen was isolated from an appropriate microbiological specimen at baseline, irrespective of susceptibility to study therapies.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Imipenem-Relebactam Arm | Clinical Outcome in the mMITT Analysis Set at TOC. | Clinical failure | 2 Participants |
| Imipenem-Relebactam Arm | Clinical Outcome in the mMITT Analysis Set at TOC. | Clinical cure | 3 Participants |
| Imipenem-Relebactam Arm | Clinical Outcome in the mMITT Analysis Set at TOC. | Indeterminate | 2 Participants |
| Standard of Care (SOC) Arm | Clinical Outcome in the mMITT Analysis Set at TOC. | Clinical failure | 4 Participants |
| Standard of Care (SOC) Arm | Clinical Outcome in the mMITT Analysis Set at TOC. | Clinical cure | 6 Participants |
| Standard of Care (SOC) Arm | Clinical Outcome in the mMITT Analysis Set at TOC. | Indeterminate | 2 Participants |
Secondary
Infection-related Mortality in the MITT Analysis Set at LFU.
The secondary efficacy outcome is infection-related mortality of the patients in the MITT (Modified Intent-To-Treat) Analysis Set at late follow-up (LFU).
Time frame: 35 to 42 days after the start of inpatient IV study drug.
Population: Patients in MITT (Modified Intent-To-Treat) Analysis Set The MITT Analysis Set will be a subset of the ITT Analysis Set and will include all randomized patients who received any amount of inpatient IV study drug and meet minimal disease criteria (Inclusion Criterion 3). Patients will be analyzed according to randomized treatment group, regardless of treatment received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Imipenem-Relebactam Arm | Infection-related Mortality in the MITT Analysis Set at LFU. | 0 Participants |
| Standard of Care (SOC) Arm | Infection-related Mortality in the MITT Analysis Set at LFU. | 0 Participants |
Secondary
Infection-related Mortality in the MITT Analysis Set at TOC.
The secondary efficacy outcome is infection-related mortality of the patients in the MITT (Modified Intent-To-Treat) Analysis Set at test-of-cure (TOC).
Time frame: 21 to 28 days after the start of inpatient IV study drug.
Population: Participants in MITT (Modified Intent-To-Treat) Analysis Set The MITT Analysis Set will be a subset of the ITT Analysis Set and will include all randomized patients who received any amount of inpatient IV study drug and meet minimal disease criteria (Inclusion Criterion 3). Patients will be analyzed according to randomized treatment group, regardless of treatment received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Imipenem-Relebactam Arm | Infection-related Mortality in the MITT Analysis Set at TOC. | 0 Participants |
| Standard of Care (SOC) Arm | Infection-related Mortality in the MITT Analysis Set at TOC. | 0 Participants |
Secondary
Infection-related Mortality in the mMITT Analysis Set at LFU.
The secondary efficacy outcome is Infection-related mortality of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at late follow-up (LFU).
Time frame: 35 to 42 days after the start of inpatient IV study drug.
Population: Patients in mMITT (Microbiological Modified Intent-To-Treat) Analysis Set The mMITT Analysis Set will be a subset of the MITT Analysis Set and will include those patients for whom at least 1 qualifying bacterial pathogen was isolated from an appropriate microbiological specimen at baseline, irrespective of susceptibility to study therapies.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Imipenem-Relebactam Arm | Infection-related Mortality in the mMITT Analysis Set at LFU. | 0 Participants |
| Standard of Care (SOC) Arm | Infection-related Mortality in the mMITT Analysis Set at LFU. | 0 Participants |
Secondary
Infection-related Mortality in the mMITT Analysis Set at TOC.
The secondary efficacy outcome is Infection-related mortality of the participants in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at test-of-cure (TOC).
Time frame: 21 to 28 days after the start of inpatient IV study drug.
Population: Patients in mMITT (Microbiological Modified Intent-To-Treat) Analysis Set The mMITT Analysis Set will be a subset of the MITT Analysis Set and will include those patients for whom at least 1 qualifying bacterial pathogen was isolated from an appropriate microbiological specimen at baseline, irrespective of susceptibility to study therapies.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Imipenem-Relebactam Arm | Infection-related Mortality in the mMITT Analysis Set at TOC. | 0 Participants |
| Standard of Care (SOC) Arm | Infection-related Mortality in the mMITT Analysis Set at TOC. | 0 Participants |
Secondary
Microbiological Outcome in the ME Analysis Set at EOIV.
The secondary efficacy outcome is favorable microbiological response of the patients in the ME (Microbiologically Evaluable) Analysis Set at end of inpatient intravenous therapy (EOIV). The microbiological response outcome has five categories: Persistence, eradication, presumed eradication, presumed persistence, and Indeterminate.
Time frame: Within 72 hours after administration of the last dose of inpatient IV study drug.
Population: Patients in ME (Microbiologically Evaluable) Analysis Set The ME Analysis Set will include patients who meet the criteria for both the CE and mMITT analysis sets.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Imipenem-Relebactam Arm | Microbiological Outcome in the ME Analysis Set at EOIV. | Eradication | 5 Participants |
| Imipenem-Relebactam Arm | Microbiological Outcome in the ME Analysis Set at EOIV. | Presumed eradication | 0 Participants |
| Standard of Care (SOC) Arm | Microbiological Outcome in the ME Analysis Set at EOIV. | Eradication | 5 Participants |
| Standard of Care (SOC) Arm | Microbiological Outcome in the ME Analysis Set at EOIV. | Presumed eradication | 2 Participants |
Secondary
Microbiological Outcome in the ME Analysis Set at LFU.
The secondary efficacy outcome is favorable microbiological response of the participants in the ME (Microbiologically Evaluable) Analysis Set at late follow-up (LFU). The microbiological response outcome has five categories: Persistence, eradication, presumed eradication, presumed persistence, and Indeterminate.
Time frame: 35 to 42 days after the start of inpatient IV study drug.
Population: Patients in ME (Microbiologically Evaluable) Analysis Set The ME Analysis Set will include patients who meet the criteria for both the CE and mMITT analysis sets.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Imipenem-Relebactam Arm | Microbiological Outcome in the ME Analysis Set at LFU. | Presumed eradication | 0 Participants |
| Imipenem-Relebactam Arm | Microbiological Outcome in the ME Analysis Set at LFU. | Eradication | 5 Participants |
| Standard of Care (SOC) Arm | Microbiological Outcome in the ME Analysis Set at LFU. | Eradication | 6 Participants |
| Standard of Care (SOC) Arm | Microbiological Outcome in the ME Analysis Set at LFU. | Presumed eradication | 1 Participants |
Secondary
Microbiological Outcome in the ME Analysis Set at TOC.
The secondary efficacy outcome is favorable microbiological response of the patients in the ME (Microbiologically Evaluable) Analysis Set at test-of-cure (TOC). The microbiological response outcome has five categories: Persistence, eradication, presumed eradication, presumed persistence, and Indeterminate.
Time frame: 21 to 28 days after the start of inpatient IV study drug.
Population: Patients in ME (Microbiologically Evaluable) Analysis Set The ME Analysis Set will include patients who meet the criteria for both the CE and mMITT analysis sets.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Imipenem-Relebactam Arm | Microbiological Outcome in the ME Analysis Set at TOC. | Eradication | 5 Participants |
| Imipenem-Relebactam Arm | Microbiological Outcome in the ME Analysis Set at TOC. | Presumed eradication | 0 Participants |
| Standard of Care (SOC) Arm | Microbiological Outcome in the ME Analysis Set at TOC. | Eradication | 6 Participants |
| Standard of Care (SOC) Arm | Microbiological Outcome in the ME Analysis Set at TOC. | Presumed eradication | 1 Participants |
Secondary
Microbiological Outcome in the mMITT Analysis Set at EOIV.
The secondary efficacy outcome is favorable microbiological response of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at end of inpatient intravenous therapy (EOIV). The microbiological response outcome has five categories: Persistence, eradication, presumed eradication, presumed persistence, and Indeterminate.
Time frame: Within 72 hours after administration of the last dose of inpatient IV study drug.
Population: Patients in mMITT (Microbiological Modified Intent-To-Treat) Analysis Set The mMITT Analysis Set will be a subset of the MITT Analysis Set and will include those patients for whom at least 1 qualifying bacterial pathogen was isolated from an appropriate microbiological specimen at baseline, irrespective of susceptibility to study therapies.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Imipenem-Relebactam Arm | Microbiological Outcome in the mMITT Analysis Set at EOIV. | Eradication | 7 Participants |
| Imipenem-Relebactam Arm | Microbiological Outcome in the mMITT Analysis Set at EOIV. | Presumed eradication | 0 Participants |
| Imipenem-Relebactam Arm | Microbiological Outcome in the mMITT Analysis Set at EOIV. | Indeterminate | 0 Participants |
| Standard of Care (SOC) Arm | Microbiological Outcome in the mMITT Analysis Set at EOIV. | Eradication | 9 Participants |
| Standard of Care (SOC) Arm | Microbiological Outcome in the mMITT Analysis Set at EOIV. | Presumed eradication | 2 Participants |
| Standard of Care (SOC) Arm | Microbiological Outcome in the mMITT Analysis Set at EOIV. | Indeterminate | 1 Participants |
Secondary
Microbiological Outcome in the mMITT Analysis Set at LFU.
The secondary efficacy outcome is favorable microbiological response of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at late follow-up (LFU). The microbiological response outcome has five categories: Persistence, eradication, presumed eradication, presumed persistence, and Indeterminate.
Time frame: 35 to 42 days after the start of inpatient IV study drug.
Population: Patients in mMITT (Microbiological Modified Intent-To-Treat) Analysis Set The mMITT Analysis Set will be a subset of the MITT Analysis Set and will include those patients for whom at least 1 qualifying bacterial pathogen was isolated from an appropriate microbiological specimen at baseline, irrespective of susceptibility to study therapies.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Imipenem-Relebactam Arm | Microbiological Outcome in the mMITT Analysis Set at LFU. | Eradication | 5 Participants |
| Imipenem-Relebactam Arm | Microbiological Outcome in the mMITT Analysis Set at LFU. | Presumed eradication | 0 Participants |
| Imipenem-Relebactam Arm | Microbiological Outcome in the mMITT Analysis Set at LFU. | Indeterminate | 2 Participants |
| Standard of Care (SOC) Arm | Microbiological Outcome in the mMITT Analysis Set at LFU. | Indeterminate | 1 Participants |
| Standard of Care (SOC) Arm | Microbiological Outcome in the mMITT Analysis Set at LFU. | Eradication | 10 Participants |
| Standard of Care (SOC) Arm | Microbiological Outcome in the mMITT Analysis Set at LFU. | Presumed eradication | 1 Participants |
Secondary
Microbiological Outcome in the mMITT Analysis Set at TOC.
The secondary efficacy outcome is favorable microbiological response of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at test-of-cure (TOC). The microbiological response outcome has five categories: Persistence, eradication, presumed eradication, presumed persistence, and Indeterminate.
Time frame: 21 to 28 days after the start of inpatient IV study drug.
Population: Patients in mMITT (Microbiological Modified Intent-To-Treat) Analysis Set The mMITT Analysis Set will be a subset of the MITT Analysis Set and will include those patients for whom at least 1 qualifying bacterial pathogen was isolated from an appropriate microbiological specimen at baseline, irrespective of susceptibility to study therapies.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Imipenem-Relebactam Arm | Microbiological Outcome in the mMITT Analysis Set at TOC. | Presumed eradication | 0 Participants |
| Imipenem-Relebactam Arm | Microbiological Outcome in the mMITT Analysis Set at TOC. | Eradication | 5 Participants |
| Imipenem-Relebactam Arm | Microbiological Outcome in the mMITT Analysis Set at TOC. | Indeterminate | 2 Participants |
| Standard of Care (SOC) Arm | Microbiological Outcome in the mMITT Analysis Set at TOC. | Presumed eradication | 1 Participants |
| Standard of Care (SOC) Arm | Microbiological Outcome in the mMITT Analysis Set at TOC. | Eradication | 10 Participants |
| Standard of Care (SOC) Arm | Microbiological Outcome in the mMITT Analysis Set at TOC. | Indeterminate | 1 Participants |