Hematopoietic and Lymphoid Cell NeoplasmPhase 2NCT04983901
PHASE II SINGLE-CENTER, RANDOMIZED, OPEN-LABEL, PROSPECTIVE, STUDY TO DETERMINE THE IMPACT OF SERIAL PROCALCITONIN
A Phase 2 study testing Imipenem/Cilastatin/Relebactam, Cefepime and Meropenem in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Imipenem/Cilastatin/Relebactam, Cefepime and Meropenem
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2021to 6 Oct 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Investigator Initiated, Phase II Single-Center, Randomized, Open-Label, Prospective, Study To Determine The Impact Of Serial Procalcitonin On Improving Antimicrobial Stewardship And On The Efficacy, Safety, And Tolerability Of Imipenem-Cilastatin-Relebactam Plus/Minus Vancomycin Or Linezolid Versus Standard Of Care Antipseudomonal Beta-Lactams Plus/Minus Vancomycin Or Linezolid As Empiric Therapy In Febrile Neutropenic Adults With Cancer
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Being tested
- Imipenem/Cilastatin/Relebactam, Cefepime, Meropenem, Piperacillin-Tazobactam, Vancomycin
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imipenem/Cilastatin/RelebactamDrug
Also called RECARBRIO™
Given IV
CefepimeDrug
Given IV
MeropenemDrug
Also called Meropenem Trihydrate, Merrem I.V., SM-7338
Given IV
Piperacillin-TazobactamDrug
Also called PIPER/TAZO, Piperacillin/Tazobactam, Zosyn
Given IV
VancomycinDrug
Given IV
DaptomycinDrug
Also called Cubicin, LY146032
Given IV
LinezolidDrug
Also called Zyvox
Given IV or PO
| Study group | Role | What they receive |
|---|---|---|
| Group I (imipenem, cilastatin, relebactam) | Experimental | Patients receive imipenem/cilastatin/relebactam IV over 30-60 minutes 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 PO q12h. Patients may continue to receive imipenem/cilastatin/relebactam IVover 30-60 minutes for up to 14 days if clinically indicated by the assessment of the treating physician. Receives: Drug: Imipenem/Cilastatin/Relebactam; Drug: Vancomycin; Drug: Daptomycin; Drug: Linezolid |
| Group II (cefepime, meropenem, piperacillin/tazobactam) | Active comparator | 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. Receives: Drug: Cefepime; Drug: Meropenem; Drug: Piperacillin-Tazobactam; Drug: Vancomycin; Drug: Daptomycin; Drug: Linezolid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 72 hours after administration of the last dose of inpatient IV study drug.
Secondary outcomes (23)
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.
Measured: Within 72 hours after administration of the last dose of inpatient IV study drug.
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.
Measured: Within 72 hours after administration of the last dose of inpatient IV study drug.
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.
Measured: 21 to 28 days after the start of inpatient IV study drug.
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.
Measured: 35 to 42 days after the start of inpatient IV study drug.
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.
Measured: 21 to 28 days after the start of inpatient IV study drug.
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.
Measured: Pateints in mMITT (Microbiological Modified Intent-To-Treat) Analysis Set
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.
Measured: 21 to 28 days after the start of inpatient IV study drug.
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.
Measured: 35 to 42 days after the start of inpatient IV study drug.
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.
Measured: Within 72 hours after administration of the last dose of inpatient IV study drug.
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.
Measured: 21 to 28 days after the start of inpatient IV study drug.
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.
Measured: 35 to 42 days after the start of inpatient IV study drug.
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.
Measured: Within 72 hours after administration of the last dose of inpatient IV study drug.
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.
Measured: 21 to 28 days after the start of inpatient IV study drug.
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.
Measured: 35 to 42 days after the start of inpatient IV study drug.
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.
Measured: Within 72 hours after administration of the last dose of inpatient IV study drug.
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.
Measured: 21 to 28 days after the start of inpatient IV study drug.
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.
Measured: 35 to 42 days after the start of inpatient IV study drug.
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).
Measured: 21 to 28 days after the start of inpatient IV study drug.
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).
Measured: 35 to 42 days after the start of inpatient IV study drug.
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).
Measured: 21 to 28 days after the start of inpatient IV study drug.
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).
Measured: 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 30-day all-cause mortality of the patients in the MITT (Modified Intent-To-Treat) Analysis Set.
Measured: 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 30-day all-cause mortality of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set.
Measured: 30 days after the last dose of inpatient IV study drug.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start14 Sep 2021
- Primary completion6 Oct 2023
- Study completion6 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hematopoietic and Lymphoid Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Issam I Raad, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04983901
- Sponsor's protocol ID
- 2020-0074
- Other IDs
- NCI-2021-01957, 2020-0074
- Status last verified
- Mar 2026
- First submitted
- 21 Jul 2021
- Last updated
- 6 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Dagher H, Chaftari AM, Hachem R, Jiang Y, Philip A, Mulanovich P, Haddad A, Lamie P, Wilson Dib R, John TM, Dailey Garnes NJM, Ali S, Chaftari P, Raad II. Procalcitonin Level Monitoring in Antibiotic De-Escalation and Stewardship Program for Patients with Cancer and Febrile Neutropenia. Cancers (Basel). 2024 Oct 11;16(20):3450. doi: 10.3390/cancers16203450.
PubMed 39456544
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator Initiated, Phase II Single-Center, Randomized, Open-Label, Prospective, Study To Determine The Impact Of Serial Procalcitonin On Improving Antimicrobial Stewardship And On The Efficacy, Safety, And Tolerability Of Imipenem-Cilastatin-Relebactam Plus/Minus Vancomycin Or Linezolid Versus Standard Of Care Antipseudomonal Beta-Lactams Plus/Minus Vancomycin Or Linezolid As Empiric Therapy In Febrile Neutropenic Adults With Cancer
- ClinicalTrials.gov ID
- NCT04983901
- Acronym / sponsor ID
- 2020-0074
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 6 Oct 2023 (actual)
- Study completion
- 6 Oct 2023 (actual)
- First posted
- 30 Jul 2021 (actual)
- Results
- Posted 12 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (imipenem, cilastatin, relebactam) | Experimental | Drug: Imipenem/Cilastatin/Relebactam, Drug: Vancomycin, Drug: Daptomycin, Drug: LinezolidPatients receive imipenem/cilastatin/relebactam IV over 30-60 minutes 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 PO q12h. Patients may continue to receive imipenem/cilastatin/relebactam IVover 30-60 minutes for up to 14 days if clinically indicated by the assessment of the treating physician. |
| Group II (cefepime, meropenem, piperacillin/tazobactam) | Active comparator | Drug: Cefepime, Drug: Meropenem, Drug: Piperacillin-Tazobactam, Drug: Vancomycin, Drug: Daptomycin, Drug: LinezolidPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- Single oral temperature measurement of > 100.4 degree F (38.0 degree C).
Key exclusion criteria (17 listed)
- 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):
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imipenem/Cilastatin/RelebactamAlso: RECARBRIO™Given IV | Drug | Group I (imipenem, cilastatin, relebactam) |
| CefepimeGiven IV | Drug | Group II (cefepime, meropenem, piperacillin/tazobactam) |
| MeropenemAlso: Meropenem Trihydrate, Merrem I.V., SM-7338Given IV | Drug | Group II (cefepime, meropenem, piperacillin/tazobactam) |
| Piperacillin-TazobactamAlso: PIPER/TAZO, Piperacillin/Tazobactam, ZosynGiven IV | Drug | Group II (cefepime, meropenem, piperacillin/tazobactam) |
| VancomycinGiven IV | Drug | Group I (imipenem, cilastatin, relebactam), Group II (cefepime, meropenem, piperacillin/tazobactam) |
| DaptomycinAlso: Cubicin, LY146032Given IV | Drug | Group I (imipenem, cilastatin, relebactam), Group II (cefepime, meropenem, piperacillin/tazobactam) |
| LinezolidAlso: ZyvoxGiven IV or PO | Drug | Group I (imipenem, cilastatin, relebactam), Group II (cefepime, meropenem, piperacillin/tazobactam) |
Primary outcome
Clinical Outcome in the MITT Analysis Set at EOIV.
Time frame: 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.
23 secondary outcomes
Clinical Outcome in the mMITT Analysis Set at EOIV.
Time frame: Within 72 hours after administration of the last dose of inpatient IV study drug.
Clinical Outcome in the CE Analysis Set at EOIV.
Time frame: Within 72 hours after administration of the last dose of inpatient IV study drug.
Clinical Outcome in the MITT Analysis Set at TOC.
Time frame: 21 to 28 days after the start of inpatient IV study drug.
Clinical Outcome in the MITT Analysis Set at LFU.
Time frame: 35 to 42 days after the start of inpatient IV study drug.
Clinical Outcome in the mMITT Analysis Set at TOC.
Time frame: 21 to 28 days after the start of inpatient IV study drug.
Clinical Outcome in the mMITT Analysis Set at LFU.
Time frame: Pateints in mMITT (Microbiological Modified Intent-To-Treat) Analysis Set
Clinical Outcome in the CE Analysis Set at TOC.
Time frame: 21 to 28 days after the start of inpatient IV study drug.
Clinical Outcome in the CE Analysis Set at LFU.
Time frame: 35 to 42 days after the start of inpatient IV study drug.
Clinical Outcome in the ME Analysis Set at EOIV.
Time frame: Within 72 hours after administration of the last dose of inpatient IV study drug.
Clinical Outcome in the ME Analysis Set at TOC.
Time frame: 21 to 28 days after the start of inpatient IV study drug.
Clinical Outcome in the ME Analysis Set at LFU.
Time frame: 35 to 42 days after the start of inpatient IV study drug.
Microbiological Outcome in the mMITT Analysis Set at EOIV.
Time frame: Within 72 hours after administration of the last dose of inpatient IV study drug.
Microbiological Outcome in the mMITT Analysis Set at TOC.
Time frame: 21 to 28 days after the start of inpatient IV study drug.
Microbiological Outcome in the mMITT Analysis Set at LFU.
Time frame: 35 to 42 days after the start of inpatient IV study drug.
Microbiological Outcome in the ME Analysis Set at EOIV.
Time frame: Within 72 hours after administration of the last dose of inpatient IV study drug.
Microbiological Outcome in the ME Analysis Set at TOC.
Time frame: 21 to 28 days after the start of inpatient IV study drug.
Microbiological Outcome in the ME Analysis Set at LFU.
Time frame: 35 to 42 days after the start of inpatient IV study drug.
Infection-related Mortality in the MITT Analysis Set at TOC.
Time frame: 21 to 28 days after the start of inpatient IV study drug.
Infection-related Mortality in the MITT Analysis Set at LFU.
Time frame: 35 to 42 days after the start of inpatient IV study drug.
Infection-related Mortality in the mMITT Analysis Set at TOC.
Time frame: 21 to 28 days after the start of inpatient IV study drug.
Infection-related Mortality in the mMITT Analysis Set at 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.
Time frame: 30 days after the last dose of inpatient IV study drug.
30-Day All-cause Mortality in the mMITT Analysis Set.
Time frame: 30 days after the last dose of inpatient IV study drug.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39456544Dagher H, Chaftari AM, Hachem R, Jiang Y, Philip A, Mulanovich P, Haddad A, Lamie P, Wilson Dib R, John TM, Dailey Garnes NJM, Ali S, Chaftari P, Raad II. Procalcitonin Level Monitoring in Antibiotic De-Escalation and Stewardship Program for Patients with Cancer and Febrile Neutropenia. Cancers (Basel). 2024 Oct 11;16(20):3450. doi: 10.3390/cancers16203450.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Issam I Raad principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Imipenem/Cilastatin/Relebactam, Cefepime and Meropenem in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Outcome in the MITT Analysis Set at EOIV. (time frame: Within 72 hours after administration of the last dose of inpatient IV study drug.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04983901, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.