Comparative Study To Determine The Efficacy, Safety, And Tolerability Of Ceftolozane-Tazobactam
Status:
Active, not recruiting
Trial end date:
2022-05-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborators:
Merck Sharp & Dohme Corp. National Cancer Institute (NCI)
Treatments:
Cefepime Ceftolozane Ceftolozane, tazobactam drug combination Cephalosporins Meropenem Penicillanic Acid Piperacillin Piperacillin, Tazobactam Drug Combination Tazobactam Thienamycins