Febrile episode in non-Hodgkin lymphoma Febrile episode Non-Hodgkin lymphoma Levofloxacin R-CHOP
Conditions
Interventions
Levofloxacin 500 mg po ac , start 1 day after chemotherapy, for total 7 days each cycle of chemotherapy,Placebo with similar appearance to trial medication given in the same manner
Experimental Drug,Placebo Comparator Drug
LFX,PCB
Sponsors
Ratchadapisek Research Funds
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Non-Hodgkin lymphoma patients confirmed by pathology Age 18 years old or more Receive R-CHOP regimen
Exclusion criteria
Exclusion criteria: Refuse to treatment/not consent History of fluoroquinolone allergy Epilepsy QT prolongation on ECG History of serious adverse events from fluoroquinolone unable to follow up active infection or documented fever previous antibiotics within 5 days before enrollment pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Febrile episode within 120 days Core Body temperature | — |
Secondary
| Measure | Time frame |
|---|---|
| Septic shock rate within 120 days septic shock event,Infection-related mortality and all-cause mortality within 120 days death,Chemotherapy reduction rate and relative dose intensity end of R-CHOP 6 cycles event of chemotherapy reduction, RDI,Composite outcome of septic shock rate, chemotherapy dose reduction rate, infection-related mortality and all-cause mortality within 120 days Summation of each events,Onset of first febrile episode within 120 days time to first febrile episode,Febrile neutropenia rate within 120 days febile neutropenia event,fever-free survival within 120 days time to fever,Febrile neutropenia-free survival within 120 days time to event | — |
Countries
Thailand
Contacts
Public ContactMutita Surakijboworn
Faculty of Medicine, Chulalongkorn University
Outcome results
None listed