Phase 2
N=100
PHASE II SINGLE-CENTER, RANDOMIZED, OPEN-LABEL, PROSPECTIVE, STUDY TO DETERMINE THE IMPACT OF SERIAL PROCALCITONIN
Hematopoietic and Lymphoid Cell Neoplasm · Malignant Solid Neoplasm
Bottom Line
View on ClinicalTrials.gov: NCT04983901 ↗Enrolled (actual)
100
Serious AEs
59.6%
Results posted
Mar 2024
Primary outcome: Primary: Clinical Outcome in the MITT Analysis Set at EOIV. — 44; 37; 5; 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Imipenem/Cilastatin/Relebactam (Drug); Cefepime (Drug); Meropenem (Drug); Piperacillin-Tazobactam (Drug); Vancomycin (Drug); Daptomycin (Drug); Linezolid (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Outcome in the MITT Analysis Set at EOIV. |
44; 37; 5; 12; 0; 1 | — |
| SECONDARY Clinical Outcome in the mMITT Analysis Set at EOIV. |
6; 8; 1; 3; 0; 1 | — |
| SECONDARY Clinical Outcome in the CE Analysis Set at EOIV. |
37; 26; 5; 9 | — |
| SECONDARY Clinical Outcome in the MITT Analysis Set at TOC. |
35; 32; 8; 13; 6; 5 | — |
| SECONDARY Clinical Outcome in the MITT Analysis Set at LFU. |
33; 30; 8; 13; 8; 7 | — |
| SECONDARY Clinical Outcome in the mMITT Analysis Set at TOC. |
3; 6; 2; 4; 2; 2 | — |
| SECONDARY Clinical Outcome in the mMITT Analysis Set at LFU. |
3; 6; 2; 4; 2; 2 | — |
| SECONDARY Clinical Outcome in the CE Analysis Set at TOC. |
34; 25; 8; 10 | — |
| SECONDARY Clinical Outcome in the CE Analysis Set at LFU. |
32; 23; 8; 10; 2; 2 | — |
| SECONDARY Clinical Outcome in the ME Analysis Set at EOIV. |
4; 6; 1; 1 | — |
| SECONDARY Clinical Outcome in the ME Analysis Set at TOC. |
3; 5; 2; 2 | — |
| SECONDARY Clinical Outcome in the ME Analysis Set at LFU. |
3; 5; 2; 2 | — |
| SECONDARY Microbiological Outcome in the mMITT Analysis Set at EOIV. |
7; 9; 0; 2; 0; 1 | — |
| SECONDARY Microbiological Outcome in the mMITT Analysis Set at TOC. |
5; 10; 0; 1; 2; 1 | — |
| SECONDARY Microbiological Outcome in the mMITT Analysis Set at LFU. |
5; 10; 0; 1; 2; 1 | — |
| SECONDARY Microbiological Outcome in the ME Analysis Set at EOIV. |
5; 5; 0; 2 | — |
| SECONDARY Microbiological Outcome in the ME Analysis Set at TOC. |
5; 6; 0; 1 | — |
| SECONDARY Microbiological Outcome in the ME Analysis Set at LFU. |
5; 6; 0; 1 | — |
| SECONDARY Infection-related Mortality in the MITT Analysis Set at TOC. |
0; 0 | — |
| SECONDARY Infection-related Mortality in the MITT Analysis Set at LFU. |
0; 0 | — |
| SECONDARY Infection-related Mortality in the mMITT Analysis Set at TOC. |
0; 0 | — |
| SECONDARY Infection-related Mortality in the mMITT Analysis Set at LFU. |
0; 0 | — |
| SECONDARY 30-Day All-cause Mortality in the MITT Analysis Set. |
2; 3 | — |
| SECONDARY 30-Day All-cause Mortality in the mMITT Analysis Set. |
0; 0 | — |
Summary
This phase II trial studies the effect of imipenem-relebactam in treating patients with cancer who have a fever due to low white blood cell counts (febrile neutropenia). In this study, imipenem-relebactam will be compared to the standard-of-care treatment (cefepime, meropenem, or piperacillin/tazobactam) for the treatment of febrile neutropenia. Imipenem-relebactam is used to treat infections. Giving imipenem-relebactam may help to control febrile neutropenia in patients with cancer.
Eligibility Criteria
Inclusion Criteria
- Has provided written informed consent, and has the willingness and ability to comply with all study procedures
- >= 18 years old
- Patients with neutropenic fever who have existing malignancy or have undergone hematopoietic stem cell transplantation
- Neutropenic fever is defined as the presence of neutropenia defined by:
- Absolute neutrophil count (ANC) 100.4 degree F (38.0 degree C).
- Requires hospitalization for IV empiric antibiotic therapy
- If female:
- Not breastfeeding
- Agrees to not attempt to become pregnant during the study. Is surgically sterile or at least 2-years postmenopausal, or if of childbearing potential, has negative screening serum or urine pregnancy test within 5 days
- If of childbearing potential (including being 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) = 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
Data sourced from ClinicalTrials.gov (NCT04983901). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.