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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-00755 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2017-0729 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
| National Cancer Institute (NCI) | NIH |
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The goal of this clinical research study is to learn if the study drug ceftolozane-tazobactam is more effective in controlling febrile neutropenia (fever and low white blood cell counts) than using approved antibiotics in patients with cancer. The safety of ceftolozane-tazobactam will also be studied.
This is an investigational study. Ceftolozane-tazobactam is FDA approved and commercially available to treat certain types of infections. It is not approved for the treatment of febrile neutropenia, either by itself or in combination with other antibiotics. Its use to treat febrile neutropenia is investigational.
All other antibiotics given on this study are FDA approved and commercially available for the treatment of infections. However, only cefepime is specifically FDA approved to treat febrile neutropenia. The study doctor can explain how the study drugs are designed to work.
Up to 100 participants will take part in this study. All will be enrolled at MD Anderson.
Study Groups and Study Drug Administration:
If participant is found to be eligible to take part in this study and participant agrees, participant will be randomly assigned (as in the flip of a coin) to either receive either the study drug (Group 1) or a standard treatment antibiotic (Group 2). This is done because no one knows if one study group is better, the same, or worse than the other group. Both participant and the study doctor will know what participant is receiving.
If participant is in Group 1, participant will receive ceftolozane-tazobactam by vein over 1 hour every 8 hours.
If participant is in Group 2, participant will receive a standard treatment antibiotic. This may include one of the following 3 options:
cefepime by vein over about 30 minutes every 8 hours. meropenem by vein over about 30 minutes every 8 hours. piperacillin/tazobactam by vein over about 1 hour every 6 hours.
Participant will receive the study drugs by vein for at least 3 days. After 3 days, if the study doctor thinks it is in participant's best interest and participant is eligible, participant may switch to receiving a different antibiotic either by mouth or by vein. The study doctor will tell participant more about what antibiotic participant may begin to receive, how it is administered, and its possible risks. If participant begins taking the study drugs by mouth, the study doctor or study staff will tell participant how and when to take each drug.
If the doctor thinks it is needed, participant will be given additional standard drugs to help control the infection. Participant may ask the study staff for information about how the drugs are given and their risks.
Length of Study:
Participant may receive the study drugs for up to 14 days. Participant will no longer be able to receive the study drugs if the disease gets worse, if intolerable side effects occur, if participant needs treatment that is not allowed on this study, or if participant is unable to follow study directions.
Participation on this study will be over after the late follow-up visit.
Study Visits:
Participant will have the following tests/procedures while participant is in the hospital. If participant begins to take the study drugs by mouth, participant will no longer have these study visits.
Each day for up to 2 weeks, if the doctor thinks it is needed, blood (about 1 tablespoon) or urine will be collected for routine tests.
Every 2 days for up to 2 weeks, blood (about 1 tablespoon) will be drawn to check for infection. Participant will stop having these blood draws when there is no longer a sign of infection and participant does not have a fever.
Twice each week for up to 2 weeks, participant will have a physical exam.
Follow-Up:
Within 72 hours (3 days) after participant's last dose of participant's assigned study treatment and before starting the second antibiotic therapy (if applicable):
Participant will have a physical exam. Blood (about 1 tablespoon) and urine will be collected for routine tests. If participant tested positive for infection at the beginning of the study, blood (about 1 tablespoon) will be drawn to check for infection. The study doctor will tell participant if participant will have this blood draw.
About 21-28 days (3-4 weeks) after participant's first dose of study drug, participant will return to MD Anderson for the following tests/procedures:
Participant will have a physical exam. If participant tested positive for infection at the beginning of the study, blood (about 1 tablespoon) will be drawn to check for infection. The study doctor will tell participant if participant will have this blood draw.
If participant can become pregnant, blood (about 1 teaspoon) will be drawn for a pregnancy test.
About 35-42 days (5-6 weeks) after participant's first dose of study drug, a member of the study staff will call participant to ask about any new drugs participant may have started and if participant is having any side effects. If participant is called, it should last about 10 minutes. If the doctor or study staff thinks it is needed, participant will be asked to come back to the clinic for the following tests/procedures:
Participant will have a physical exam. If the doctor thinks it is needed, blood (about 1 tablespoon) will be drawn to check for infection.
At any of these follow-up visits, if participant's doctor thinks it is needed, participant will have a chest x-ray or CT scan to check participant's lungs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (ceftolozane-tazobactam) | Experimental | Participants receive ceftolozane-tazobactam IV over 1 hour every 8 hours for up to 14 days in the absence of disease progression or unacceptable toxicity. After at least 3 days, participants may switch to different PO or IV antibiotics at the discretion of the study doctor. |
|
| Group II (standard of care antibiotic treatment) | Active Comparator | Participants receive standard of care antibiotic treatment consisting of either cefepime IV over 30 minutes every 8 hours, meropenem IV over 30 minutes every 8 hours, or piperacillin-tazobactam IV over 1 hour every 6 hours for up to 14 days in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cefepime | Drug | Given IV |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Favorable Clinical Response at End of Inpatient Intravenous Therapy (EOIV) | Resolution of all acute signs and symptoms of the primary infection or improvement to such an extent that no additional antibacterial therapy is required (ie, except for protocol-allowed adjunctive therapies and/or oral or IV switch) and such that no more than 14 days of total antibacterial therapy is required. | Within 72 hours after administration of the last dose of inpatient IV study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Favorable Clinical Response in the Microbiological Modified Intent-to-treat (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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Issam I Raad | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35663286 | Derived | Chaftari AM, Hachem R, Malek AE, Mulanovich VE, Szvalb AD, Jiang Y, Yuan Y, Ali S, Deeba R, Chaftari P, Raad I. A Prospective Randomized Study Comparing Ceftolozane/Tazobactam to Standard of Care in the Management of Neutropenia and Fever in Patients With Hematological Malignancies. Open Forum Infect Dis. 2022 Feb 14;9(6):ofac079. doi: 10.1093/ofid/ofac079. eCollection 2022 Jun. |
| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ceftolozane/Tazobactam Arm | Received IV Ceftolozane/Tazobactam (minimum of 9 doses). Patients may receive other additional therapy. |
| FG001 | Standard of Care (SOC) Arm | Received one of the following IV therapies: Cefepime (minimum of 9 doses), Meropenem (minimum of 9 doses), Piperacillin/Tazobactam (minimum of 12 doses). Patients may receive other additional therapy. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Patients in Modified Intent-To-Treat (MITT) analysis set
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| ID | Title | Description |
|---|---|---|
| BG000 | Ceftolozane/Tazobactam Arm | Received IV Ceftolozane/Tazobactam (minimum of 9 doses). Patients may receive other additional therapy. |
| BG001 | Standard of Care (SOC) Arm | Received one of the following IV therapies: Cefepime (minimum of 9 doses), Meropenem (minimum of 9 doses), Piperacillin/Tazobactam (minimum of 12 doses). Patients may receive other additional therapy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Favorable Clinical Response at End of Inpatient Intravenous Therapy (EOIV) | Resolution of all acute signs and symptoms of the primary infection or improvement to such an extent that no additional antibacterial therapy is required (ie, except for protocol-allowed adjunctive therapies and/or oral or IV switch) and such that no more than 14 days of total antibacterial therapy is required. | Patients in MITT (Modified Intent-To-Treat) Analysis Set | Posted | Count of Participants | Participants | Within 72 hours after administration of the last dose of inpatient IV study drug |
|
From the date of the first dose of IV study drug to 30 days following the last dose of study drug. All patients were followed until last follow up which occurred 35-42 days following the first dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ceftolozane/Tazobactam Arm | Received IV Ceftolozane/Tazobactam (minimum of 9 doses). Patients may receive other additional therapy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ALT elevation | Hepatobiliary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Issam Raad,MD - Chair, Infectious Diseases | UT MD Anderson Cancer Center | (713) 792-7943 | iraad@mdanderson.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 16, 2020 | Jun 2, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000077723 | Cefepime |
| C519491 | ceftolozane |
| D000077731 | Meropenem |
| D000077725 | Piperacillin, Tazobactam Drug Combination |
| D000078142 | Tazobactam |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
Not provided
Not provided
Not provided
Not provided
Not provided
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| Ceftolozane |
| Drug |
Given IV |
|
|
| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Meropenem | Drug | Given IV |
|
|
| Piperacillin-Tazobactam | Drug | Given IV |
|
|
| Tazobactam | Drug | Given IV |
|
|
| Within 72 hours after administration of the last dose of inpatient IV study drug. |
| Number of Participants With Favorable Clinical Response in the Clinically Evaluable (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. | Within 72 hours after administration of the last dose of inpatient IV study drug. |
| Number of Participants With Favorable Clinical Response 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: Favorable clinical response, Clinical failure, and Indeterminate. | 21 to 28 days after the start of inpatient IV study drug |
| Number of Participants With Favorable Clinical Response in the MITT Analysis Set at Late Follow-Up (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: Favorable clinical response, Clinical failure, and Indeterminate. | 35 to 42 days after the start of inpatient IV study drug |
| Number of Participants With Favorable Clinical Response in the mMITT Analysis Set at Test of Cure (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: Favorable clinical response, Clinical failure, and Indeterminate. | 21 to 28 days after the start of inpatient IV study drug. |
| Number of Participants With Favorable Clinical Response in the mMITT Analysis Set at Late Follow-Up (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: Favorable clinical response, Clinical failure, and Indeterminate. | 35 to 42 days after the start of inpatient IV study drug |
| Number of Participants With Favorable Clinical Response 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: Favorable clinical response, Clinical failure, and Indeterminate. | 21 to 28 days after the start of inpatient IV study drug |
| Number of Participants With Favorable Clinical Response 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: Favorable clinical response, Clinical failure, and Indeterminate. | 35 to 42 days after the start of inpatient IV study drug |
| Number of Participants With Favorable Clinical Response 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. | Within 72 hours after administration of the last dose of inpatient IV study drug. |
| Number of Participants With Favorable Clinical Response 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: Favorable clinical response, Clinical failure, and Indeterminate. | 21 to 28 days after the start of inpatient IV study drug. |
| Number of Participants With Favorable Clinical Response 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: Favorable clinical response, Clinical failure, and Indeterminate. | 35 to 42 days after the start of inpatient IV study drug |
| Number of Participants With Favorable Microbiological Response 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 clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate. | Within 72 hours after administration of the last dose of inpatient IV study drug |
| Favorable Microbiological Response 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 clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate. | 21 to 28 days after the start of inpatient IV study drug |
| Number of Participants With Favorable Microbiological Response 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 clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate. | 35 to 42 days after the start of inpatient IV study drug. |
| Number of Participants With Favorable Microbiological Response 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. | Within 72 hours after administration of the last dose of inpatient IV study drug |
| Number of Participants With Favorable Microbiological Response 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 clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate. | 21 to 28 days after the start of inpatient IV study drug |
| Number of Participants With Favorable Microbiological Response in the ME Analysis Set at LFU | The secondary efficacy outcome is favorable microbiological response of the patients in the ME (Microbiologically Evaluable) Analysis Set at late follow-up (LFU). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate. | 35 to 42 days after the start of inpatient IV study drug |
| Number of Participants With 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). | 21 to 28 days after the start of inpatient IV study drug |
| Number of Participants With 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). | 35 to 42 days after the start of inpatient IV study drug |
| Number of Participants With Infection-related Mortality the mMITT Analysis Set at TOC | The secondary efficacy outcome is infection-related mortality of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at test-of-cure (TOC). | 21 to 28 days after the start of inpatient IV study drug |
| Number of Participants With 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). | 35 to 42 days after the start of inpatient IV study drug |
| 30 Day All-cause Mortality in the MITT Analysis Set | The secondary efficacy outcome is all-cause mortality of the patients in the MITT (Modified Intent-To-Treat) Analysis Set, which is mortality within 30 days after the last dose of inpatient IV study drug. | 30 days after the last dose of inpatient IV study drug |
| 30 Day All-cause Mortality in the mMITT Analysis Set | The secondary efficacy outcome is all-cause mortality of the patients in the mMITT (microbiological Modified Intent-To-Treat) Analysis Set, which is mortality within 30 days after the last dose of inpatient IV study drug. | 30 days after the last dose of inpatient IV study drug |
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Type of Hematological malignancy | Count of Participants | Participants |
|
| History of Bone Marrow Transplant (BMT) within 1 year | Count of Participants | Participants |
|
| Temperature at initial presentation | Count of Participants | Participants |
|
| Site of Microorganisms | Count of Participants | Participants |
|
| Organism of positive culture | Count of Participants | Participants |
|
| Temperature at baseline | Median | Inter-Quartile Range | Celsius |
|
| Microbiology Documentation | Site of Microorganisms | Count of Participants | Participants |
|
| Bacterial Pathogen Causing Documented Infection | Count of Participants | Participants |
|
| Standard of Care (SOC) Arm |
Received one of the following IV therapies: Cefepime (minimum of 9 doses), Meropenem (minimum of 9 doses), Piperacillin/Tazobactam (minimum of 12 doses). Patients may receive other additional therapy. |
|
|
| Secondary | Number of Participants With Favorable Clinical Response in the Microbiological Modified Intent-to-treat (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. | Patients in mMITT (Microbiological Modified Intent-To-Treat) Analysis Set | Posted | Count of Participants | Participants | Within 72 hours after administration of the last dose of inpatient IV study drug. |
|
|
|
| Secondary | Number of Participants With Favorable Clinical Response in the Clinically Evaluable (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. | Patients in CE (Clinically Evaluable) Analysis Set | Posted | Count of Participants | Participants | Within 72 hours after administration of the last dose of inpatient IV study drug. |
|
|
|
| Secondary | Number of Participants With Favorable Clinical Response 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: Favorable clinical response, Clinical failure, and Indeterminate. | Patients in the MITT (Modified Intent-To-Treat) Analysis Set | Posted | Count of Participants | Participants | 21 to 28 days after the start of inpatient IV study drug |
|
|
|
| Secondary | Number of Participants With Favorable Clinical Response in the MITT Analysis Set at Late Follow-Up (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: Favorable clinical response, Clinical failure, and Indeterminate. | Patients in the MITT (Modified Intent-To-Treat) Analysis Set | Posted | Count of Participants | Participants | 35 to 42 days after the start of inpatient IV study drug |
|
|
|
| Secondary | Number of Participants With Favorable Clinical Response in the mMITT Analysis Set at Test of Cure (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: Favorable clinical response, Clinical failure, and Indeterminate. | Patients in mMITT (Microbiological Modified Intent-To-Treat) Analysis Set | Posted | Count of Participants | Participants | 21 to 28 days after the start of inpatient IV study drug. |
|
|
|
| Secondary | Number of Participants With Favorable Clinical Response in the mMITT Analysis Set at Late Follow-Up (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: Favorable clinical response, Clinical failure, and Indeterminate. | Patients in mMITT (Microbiological Modified Intent-To-Treat) Analysis Set | Posted | Count of Participants | Participants | 35 to 42 days after the start of inpatient IV study drug |
|
|
|
| Secondary | Number of Participants With Favorable Clinical Response 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: Favorable clinical response, Clinical failure, and Indeterminate. | Patients in CE (Clinically Evaluable) Analysis Set | Posted | Count of Participants | Participants | 21 to 28 days after the start of inpatient IV study drug |
|
|
|
| Secondary | Number of Participants With Favorable Clinical Response 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: Favorable clinical response, Clinical failure, and Indeterminate. | Patients in CE (Clinically Evaluable) Analysis Set | Posted | Count of Participants | Participants | 35 to 42 days after the start of inpatient IV study drug |
|
|
|
| Secondary | Number of Participants With Favorable Clinical Response 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. | Patients in CE analysis set with baseline Gram-negative pathogen (= ME (Microbiologically Evaluable) Analysis Set) | Posted | Count of Participants | Participants | Within 72 hours after administration of the last dose of inpatient IV study drug. |
|
|
|
| Secondary | Number of Participants With Favorable Clinical Response 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: Favorable clinical response, Clinical failure, and Indeterminate. | Patients in CE analysis set with baseline Gram-negative pathogen (= ME (Microbiologically Evaluable) Analysis Set) | Posted | Count of Participants | Participants | 21 to 28 days after the start of inpatient IV study drug. |
|
|
|
| Secondary | Number of Participants With Favorable Clinical Response 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: Favorable clinical response, Clinical failure, and Indeterminate. | Patients in CE analysis set with baseline Gram-negative pathogen (= ME (Microbiologically Evaluable) Analysis Set) | Posted | Count of Participants | Participants | 35 to 42 days after the start of inpatient IV study drug |
|
|
|
| Secondary | Number of Participants With Favorable Microbiological Response 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 clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate. | Patients in mMITT (Microbiological Modified Intent-To-Treat) Analysis Set | Posted | Count of Participants | Participants | Within 72 hours after administration of the last dose of inpatient IV study drug |
|
|
|
| Secondary | Favorable Microbiological Response 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 clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate. | Patients in mMITT (Microbiological Modified Intent-To-Treat) Analysis Set | Posted | Count of Participants | Participants | 21 to 28 days after the start of inpatient IV study drug |
|
|
|
| Secondary | Number of Participants With Favorable Microbiological Response 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 clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate. | Patients in mMITT (Microbiological Modified Intent-To-Treat) Analysis Set | Posted | Count of Participants | Participants | 35 to 42 days after the start of inpatient IV study drug. |
|
|
|
| Secondary | Number of Participants With Favorable Microbiological Response 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. | Patients in ME (Microbiologically Evaluable) Analysis Set | Posted | Count of Participants | Participants | Within 72 hours after administration of the last dose of inpatient IV study drug |
|
|
|
| Secondary | Number of Participants With Favorable Microbiological Response 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 clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate. | Patients in ME (Microbiologically Evaluable) Analysis Set. | Posted | Count of Participants | Participants | 21 to 28 days after the start of inpatient IV study drug |
|
|
|
| Secondary | Number of Participants With Favorable Microbiological Response in the ME Analysis Set at LFU | The secondary efficacy outcome is favorable microbiological response of the patients in the ME (Microbiologically Evaluable) Analysis Set at late follow-up (LFU). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate. | Posted | Count of Participants | Participants | 35 to 42 days after the start of inpatient IV study drug |
|
|
|
| Secondary | Number of Participants With 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). | Patients in MITT (Modified Intent-To-Treat) Analysis Set | Posted | Count of Participants | Participants | 21 to 28 days after the start of inpatient IV study drug |
|
|
|
| Secondary | Number of Participants With 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). | Patients in MITT (Modified Intent-to-Treat) Analysis Set | Posted | Count of Participants | Participants | 35 to 42 days after the start of inpatient IV study drug |
|
|
|
| Secondary | Number of Participants With Infection-related Mortality the mMITT Analysis Set at TOC | The secondary efficacy outcome is infection-related mortality of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at test-of-cure (TOC). | Patients in mMITT (Microbiological Modified Intent-To-Treat) Analysis Set | Posted | Count of Participants | Participants | 21 to 28 days after the start of inpatient IV study drug |
|
|
|
| Secondary | Number of Participants With 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). | Posted | Count of Participants | Participants | 35 to 42 days after the start of inpatient IV study drug |
|
|
|
| Secondary | 30 Day All-cause Mortality in the MITT Analysis Set | The secondary efficacy outcome is all-cause mortality of the patients in the MITT (Modified Intent-To-Treat) Analysis Set, which is mortality within 30 days after the last dose of inpatient IV study drug. | Patients in MITT (Modified Intent-To-Treat) Analysis Set | Posted | Count of Participants | Participants | 30 days after the last dose of inpatient IV study drug |
|
|
|
| Secondary | 30 Day All-cause Mortality in the mMITT Analysis Set | The secondary efficacy outcome is all-cause mortality of the patients in the mMITT (microbiological Modified Intent-To-Treat) Analysis Set, which is mortality within 30 days after the last dose of inpatient IV study drug. | Patients in mMITT (Modified Intent-To-Treat) Analysis Set | Posted | Count of Participants | Participants | 30 days after the last dose of inpatient IV study drug |
|
|
|
| 3 |
| 47 |
| 33 |
| 47 |
| 9 |
| 47 |
| EG001 | Standard of Care (SOC) Arm | Received one of the following IV therapies: Cefepime (minimum of 9 doses), Meropenem (minimum of 9 doses), Piperacillin/Tazobactam (minimum of 12 doses). Patients may receive other additional therapy. | 2 | 50 | 33 | 50 | 6 | 50 |
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
|
| Bacterial infection | Infections and infestations | Systematic Assessment |
|
| Bilirubin increased | Hepatobiliary disorders | Systematic Assessment |
|
| Bloodstream infection | Infections and infestations | Systematic Assessment |
|
| Catheter related infection | Infections and infestations | Systematic Assessment |
|
| Chest pain | Cardiac disorders | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | Systematic Assessment |
|
| Confusion | Nervous system disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Creatinine increased | Renal and urinary disorders | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
|
| Disease progression | General disorders | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | Systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Heart failure | Cardiac disorders | Systematic Assessment |
|
| Hypernatremia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
| Hypotension | Vascular disorders | Systematic Assessment |
|
| Infections and infestations | Infections and infestations | Systematic Assessment |
|
| Intracranial hemorrhage | Nervous system disorders | Systematic Assessment |
|
| Lung infection | Infections and infestations | Systematic Assessment |
|
| Multi-organ failure | General disorders | Systematic Assessment |
|
| Papilledema | Eye disorders | Systematic Assessment |
|
| Pulmonary embolism | Vascular disorders | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Retroperitoneal hemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Sepsis | Infections and infestations | Systematic Assessment |
|
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Sinusitis | Infections and infestations | Systematic Assessment |
|
| Skin infection | Infections and infestations | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Splenic infection | Infections and infestations | Systematic Assessment |
|
| Syncope | Nervous system disorders | Systematic Assessment |
|
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | Systematic Assessment |
|
| Vascular access complication | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Viral hepatitis | Infections and infestations | Systematic Assessment |
|
| Viral infection | Infections and infestations | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D013845 | Thienamycins |
| D015780 | Carbapenems |
| D010397 | Penicillanic Acid |
| D010406 | Penicillins |
| D010878 | Piperacillin |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D013450 | Sulfones |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |