Status:
COMPLETED
Comparative Study To Determine The Efficacy, Safety, And Tolerability Of Ceftolozane-Tazobactam
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Merck Sharp & Dohme LLC
National Cancer Institute (NCI)
Conditions:
Other Infectious Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ap...
Detailed Description
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) ...
Eligibility Criteria
Inclusion
- 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) \< 500 cells/mm\^3 or has an ANC that is expected to decrease to \< 500 cells/mm\^3 within 48 hours of trial entry and fever defined as: 2) single oral temperature measurement of \> 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 \< 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 for ≥ 28 days after the last dose of any study therapy (IV or oral)
Exclusion
- History of any hypersensitivity or allergic reaction to any cephalosporin antibiotic or tazobactam
- 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)
- Known acute viral hepatitis
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level \> 5 times the upper limit of normal (x ULN); patients with values \> 3 x ULN and \< 5 x ULN are eligible if the value is acute and directly related to the infectious process being treated
- 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 \> 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
Key Trial Info
Start Date :
May 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 16 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03485950
Start Date
May 16 2018
End Date
February 16 2022
Last Update
March 15 2022
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030