A Phase 2 interventional study of Cefepime and Ceftolozane in Other Infectious Diseases, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-15.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
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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.
M.D. Anderson Cancer Center is the lead sponsor of 3,047 studies on the registry; 578 are open to participants now.
Of its 612 completed or terminated interventional studies of FDA-regulated products, 409 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Ceftolozane · Other: Laboratory Biomarker Analysis · Drug: Tazobactam
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.
Drug: Cefepime · Other: Laboratory Biomarker Analysis · Drug: Meropenem · Drug: Piperacillin-Tazobactam · Drug: Tazobactam
Given IV
Given IV
Also known as: CXA-101
Correlative studies
Given IV
Also known as: Meropenem Trihydrate, Merrem I.V., SM-7338
Given IV
Also known as: PIPER/TAZO, Piperacillin/Tazobactam, Zosyn
Given IV
Also known as: YTR-830H
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.
Time frame: Within 72 hours after administration of the last dose of inpatient IV study drug
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 30 days after the last dose of inpatient IV study drug
| Milestone | Ceftolozane/Tazobactam Arm | Standard of Care (SOC) Arm |
|---|---|---|
| Started | 50 | 50 |
| Completed | 43 | 48 |
| Not completed | 7 | 2 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Death | 3 | 2 |
| Withdrew: Withdrawal by subject | 3 | 0 |
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.
| Participants | Ceftolozane/Tazobactam Arm | Standard of Care (SOC) Arm |
|---|---|---|
| Number of Participants With Favorable Clinical Response at End of Inpatient Intravenous Therapy (EOIV) | 41 | 36 |
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.
| Participants | Ceftolozane/Tazobactam Arm | Standard of Care (SOC) Arm |
|---|---|---|
| Number of Participants With Favorable Clinical Response in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set at EOIV. | 3 | 1 |
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.
| Participants | Ceftolozane/Tazobactam Arm | Standard of Care (SOC) Arm |
|---|---|---|
| Number of Participants With Favorable Clinical Response in the Clinically Evaluable (CE) Analysis Set at EOIV. | 29 | 32 |
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.
| Participants | Ceftolozane/Tazobactam Arm | Standard of Care (SOC) Arm |
|---|---|---|
| Number of Participants With Favorable Clinical Response in the MITT Analysis Set at TOC | 34 | 28 |
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.
| Participants | Ceftolozane/Tazobactam Arm | Standard of Care (SOC) Arm |
|---|---|---|
| Number of Participants With Favorable Clinical Response in the MITT Analysis Set at Late Follow-Up (LFU) | 33 | 26 |
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.
| Participants | Ceftolozane/Tazobactam Arm | Standard of Care (SOC) Arm |
|---|---|---|
| Number of Participants With Favorable Clinical Response in the mMITT Analysis Set at Test of Cure (TOC) | 3 | 1 |
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.
| Participants | Ceftolozane/Tazobactam Arm | Standard of Care (SOC) Arm |
|---|---|---|
| Number of Participants With Favorable Clinical Response in the mMITT Analysis Set at Late Follow-Up (LFU) | 3 | 1 |
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.
| Participants | Ceftolozane/Tazobactam Arm | Standard of Care (SOC) Arm |
|---|---|---|
| Number of Participants With Favorable Clinical Response in the CE Analysis Set at TOC | 28 | 26 |
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.
| Participants | Ceftolozane/Tazobactam Arm | Standard of Care (SOC) Arm |
|---|---|---|
| Number of Participants With Favorable Clinical Response in the CE Analysis Set at LFU. | 27 | 24 |
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.
| Participants | Ceftolozane/Tazobactam Arm | Standard of Care (SOC) Arm |
|---|---|---|
| Number of Participants With Favorable Clinical Response in the ME Analysis Set at EOIV. | 2 | 1 |
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.
| Participants | Ceftolozane/Tazobactam Arm | Standard of Care (SOC) Arm |
|---|---|---|
| Number of Participants With Favorable Clinical Response in the ME Analysis Set at TOC | 2 | 1 |
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.
| Participants | Ceftolozane/Tazobactam Arm | Standard of Care (SOC) Arm |
|---|---|---|
| Number of Participants With Favorable Clinical Response in the ME Analysis Set at LFU. | 2 | 1 |
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.
| Participants | Ceftolozane/Tazobactam Arm | Standard of Care (SOC) Arm |
|---|---|---|
| Number of Participants With Favorable Microbiological Response in the mMITT Analysis Set at EOIV. | 3 | 2 |
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.
| Participants | Ceftolozane/Tazobactam Arm | Standard of Care (SOC) Arm |
|---|---|---|
| Favorable Microbiological Response in the mMITT Analysis Set at TOC. | 3 | 2 |
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.
| Participants | Ceftolozane/Tazobactam Arm | Standard of Care (SOC) Arm |
|---|---|---|
| Number of Participants With Favorable Microbiological Response in the mMITT Analysis Set at LFU. | 3 | 2 |
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.
| Participants | Ceftolozane/Tazobactam Arm | Standard of Care (SOC) Arm |
|---|---|---|
| Number of Participants With Favorable Microbiological Response in the ME Analysis Set at EOIV. | 2 | 1 |
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.
| Participants | Ceftolozane/Tazobactam Arm | Standard of Care (SOC) Arm |
|---|---|---|
| Number of Participants With Favorable Microbiological Response in the ME Analysis Set at TOC. | 2 | 1 |
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.
| Participants | Ceftolozane/Tazobactam Arm | Standard of Care (SOC) Arm |
|---|---|---|
| Number of Participants With Favorable Microbiological Response in the ME Analysis Set at LFU | 2 | 1 |
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).
| Participants | Ceftolozane/Tazobactam Arm | Standard of Care (SOC) Arm |
|---|---|---|
| Number of Participants With Infection-related Mortality in the MITT Analysis Set at TOC | 0 | 0 |
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).
| Participants | Ceftolozane/Tazobactam Arm | Standard of Care (SOC) Arm |
|---|---|---|
| Number of Participants With Infection-related Mortality in the MITT Analysis Set at LFU | 0 | 0 |
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).
| Participants | Ceftolozane/Tazobactam Arm | Standard of Care (SOC) Arm |
|---|---|---|
| Number of Participants With Infection-related Mortality the mMITT Analysis Set at TOC | 0 | 0 |
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).
| Participants | Ceftolozane/Tazobactam Arm | Standard of Care (SOC) Arm |
|---|---|---|
| Number of Participants With Infection-related Mortality in the mMITT Analysis Set at LFU. | 0 | 0 |
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.
| Participants | Ceftolozane/Tazobactam Arm | Standard of Care (SOC) Arm |
|---|---|---|
| 30 Day All-cause Mortality in the MITT Analysis Set | 2 | 2 |
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.
| Participants | Ceftolozane/Tazobactam Arm | Standard of Care (SOC) Arm |
|---|---|---|
| 30 Day All-cause Mortality in the mMITT Analysis Set | 0 | 0 |
Collected over 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ceftolozane/Tazobactam Arm | 3/47 (6.4%) | 33/47 (70.2%) | 9/47 (19.1%) |
| Standard of Care (SOC) Arm | 2/50 (4%) | 33/50 (66%) | 6/50 (12%) |
| Event | Ceftolozane/Tazobactam Arm | Standard of Care (SOC) Arm |
|---|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 8/47 | 13/50 |
| Lung infectionInfections and infestations | 5/47 | 10/50 |
| FeverGeneral disorders | 6/47 | 8/50 |
| Bloodstream infectionInfections and infestations | 5/47 | 6/50 |
| Catheter related infectionInfections and infestations | 4/47 | 1/50 |
| Infections and infestationsInfections and infestations | 3/47 | 1/50 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 3/47 | 2/50 |
| EnterocolitisGastrointestinal disorders | 2/47 | 3/50 |
| Shortness of breathRespiratory, thoracic and mediastinal disorders | 2/47 | 0/50 |
| Skin infectionInfections and infestations | 2/47 | 1/50 |
| Event | Ceftolozane/Tazobactam Arm | Standard of Care (SOC) Arm |
|---|---|---|
| RashSkin and subcutaneous tissue disorders | 4/47 | 3/50 |
| ALT elevationHepatobiliary disorders | 3/47 | 3/50 |
| Urinary tract infectionInfections and infestations | 3/47 | 0/50 |
Patients in Modified Intent-To-Treat (MITT) analysis set
| Age, Continuous(years) | Ceftolozane/Tazobactam Arm | Standard of Care (SOC) Arm | Total |
|---|---|---|---|
| Median | 60 (25 to 84) | 55 (18 to 79) | 56 (18 to 84) |
| Sex: Female, Male(Participants) | Ceftolozane/Tazobactam Arm | Standard of Care (SOC) Arm | Total |
|---|---|---|---|
| Female | 19 | 18 | 37 |
| Male | 28 | 32 | 60 |
| Race/Ethnicity, Customized(Participants) | Ceftolozane/Tazobactam Arm | Standard of Care (SOC) Arm | Total |
|---|---|---|---|
| Asian | 0 | 1 | 1 |
| Black or African American | 4 | 5 | 9 |
| Hispanic or Latino | 6 | 7 | 13 |
| Middle East | 3 | 1 | 4 |
| White | 32 | 35 | 67 |
| Others | 2 | 1 | 3 |
| Region of Enrollment(participants) | Ceftolozane/Tazobactam Arm | Standard of Care (SOC) Arm | Total |
|---|---|---|---|
| United States | 47 | 50 | 97 |
| Type of Hematological malignancy(Participants) | Ceftolozane/Tazobactam Arm | Standard of Care (SOC) Arm | Total |
|---|---|---|---|
| Acute Lymphocytic Leukemia(ALL) | 9 | 12 | 21 |
| Chronic Lymphocytic Leukemia (AML) | 19 | 22 | 41 |
| Chronic Myeloid Leukemia (CML) | 3 | 0 | 3 |
| Lymphoma | 9 | 6 | 15 |
| Others | 7 | 10 | 17 |
| History of Bone Marrow Transplant (BMT) within 1 year(Participants) | Ceftolozane/Tazobactam Arm | Standard of Care (SOC) Arm | Total |
|---|---|---|---|
| Autologous | 2 | 4 | 6 |
| Allogeneic | 4 | 5 | 9 |
| Temperature at initial presentation(Participants) | Ceftolozane/Tazobactam Arm | Standard of Care (SOC) Arm | Total |
|---|---|---|---|
| < 36 Celsius | 0 | 0 | 0 |
| 36 -38 Celsius | 3 | 7 | 10 |
| >38 Celsius | 44 | 43 | 87 |
| Site of Microorganisms(Participants) | Ceftolozane/Tazobactam Arm | Standard of Care (SOC) Arm | Total |
|---|---|---|---|
| Genitourinary | 2 | 1 | 3 |
| Blood | 10 | 12 | 22 |
4 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from May 2018 to primary completion in May 2021, 35 months.
Results were first posted in Jul 2021, 2 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ceftolozane