Phase 2
N=100
Comparative Study To Determine The Efficacy, Safety, And Tolerability Of Ceftolozane-Tazobactam
Other Infectious Diseases
Bottom Line
View on ClinicalTrials.gov: NCT03485950 ↗Enrolled (actual)
100
Serious AEs
68.0%
Results posted
Jul 2021
Primary outcome: Primary: Number of Participants With Favorable Clinical Response at End of Inpatient Intravenous Therapy (EOIV) — 41; 36 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cefepime (Drug); Ceftolozane (Drug); Laboratory Biomarker Analysis (Other); Meropenem (Drug); Piperacillin-Tazobactam (Drug); Tazobactam (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Favorable Clinical Response at End of Inpatient Intravenous Therapy (EOIV) |
41; 36 | — |
| SECONDARY Number of Participants With Favorable Clinical Response in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set at EOIV. |
3; 1 | — |
| SECONDARY Number of Participants With Favorable Clinical Response in the Clinically Evaluable (CE) Analysis Set at EOIV. |
29; 32 | — |
| SECONDARY Number of Participants With Favorable Clinical Response in the MITT Analysis Set at TOC |
34; 28 | — |
| SECONDARY Number of Participants With Favorable Clinical Response in the MITT Analysis Set at Late Follow-Up (LFU) |
33; 26 | — |
| SECONDARY Number of Participants With Favorable Clinical Response in the mMITT Analysis Set at Test of Cure (TOC) |
3; 1 | — |
| SECONDARY Number of Participants With Favorable Clinical Response in the mMITT Analysis Set at Late Follow-Up (LFU) |
3; 1 | — |
| SECONDARY Number of Participants With Favorable Clinical Response in the CE Analysis Set at TOC |
28; 26 | — |
| SECONDARY Number of Participants With Favorable Clinical Response in the CE Analysis Set at LFU. |
27; 24 | — |
| SECONDARY Number of Participants With Favorable Clinical Response in the ME Analysis Set at EOIV. |
2; 1 | — |
| SECONDARY Number of Participants With Favorable Clinical Response in the ME Analysis Set at TOC |
2; 1 | — |
| SECONDARY Number of Participants With Favorable Clinical Response in the ME Analysis Set at LFU. |
2; 1 | — |
| SECONDARY Number of Participants With Favorable Microbiological Response in the mMITT Analysis Set at EOIV. |
3; 2 | — |
| SECONDARY Favorable Microbiological Response in the mMITT Analysis Set at TOC. |
3; 2 | — |
| SECONDARY Number of Participants With Favorable Microbiological Response in the mMITT Analysis Set at LFU. |
3; 2 | — |
| SECONDARY Number of Participants With Favorable Microbiological Response in the ME Analysis Set at EOIV. |
2; 1 | — |
| SECONDARY Number of Participants With Favorable Microbiological Response in the ME Analysis Set at TOC. |
2; 1 | — |
| SECONDARY Number of Participants With Favorable Microbiological Response in the ME Analysis Set at LFU |
2; 1 | — |
| SECONDARY Number of Participants With Infection-related Mortality in the MITT Analysis Set at TOC |
0; 0 | — |
| SECONDARY Number of Participants With Infection-related Mortality in the MITT Analysis Set at LFU |
0; 0 | — |
| SECONDARY Number of Participants With Infection-related Mortality the mMITT Analysis Set at TOC |
0; 0 | — |
| SECONDARY Number of Participants With Infection-related Mortality in the mMITT Analysis Set at LFU. |
0; 0 | — |
| SECONDARY 30 Day All-cause Mortality in the MITT Analysis Set |
2; 2 | — |
| SECONDARY 30 Day All-cause Mortality in the mMITT Analysis Set |
0; 0 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Has provided written informed consent, and has the willingness and ability to comply with all study procedures
- 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: 1) absolute neutrophil count (ANC) 101 degree Fahrenheit (F) (38.3 degree Celsius [C]) or a temperature of > 100.4 degree F (38.0 degree C) sustained over a 1-hour period
- 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 pregnancy test (if serum pregnancy test results are not available at the time of enrollment, a negative urine pregnancy test is required within 24 hours.); if of childbearing potential (including being 5 times the upper limit of normal (x ULN); patients with values > 3 x ULN and 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) = 24 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
- Requirement for any non-study potentially effective concomitant systemic antibacterial therapy
- 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 ceftolozane/tazobactam trial
Data sourced from ClinicalTrials.gov (NCT03485950). 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.