Febrile neutropenia in patients with lung cancer
Conditions
Interventions
Cefepime (1g every 8 hours intravenously) treatment
Sponsors
Central Japan Lung Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with lung cancer who are treated with chemotherapy or chemoradiotherapy 2) Fever defined as an axillary temperature 38 oC or greater 3) Neutropenia defined as an absolute neutrophil count of less than 500/mm3 or less than 1000/mm3 with provision to fall to less than 500/mm3 within the next 48 hours 4) ALT and AST less than 200 IU/L Serum creatinine less than 2.0 mg/dL 5) Age of 18 years or older 6) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Infection in which the study drug is considered to be ineffective 2) Medical history of anaphylaxis or hypersensitivity to beta-lactams 3) Positive skin test to the study drug if skin testing is performed 4) Sings and symptoms of shock 5) Mycobacterial, fungal, rickettsial, viral, chlamydial, parasitic or protozoal infection 6) Prior history of antimicrobial therapy (prophylaxis with trimethoprin-sulfapethoxazole is excluded) within the past 14 days 7) Pregnant or nursing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate at the completion of cefepime treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Defervescence rate at 72 hours Safety Survival status at day 30 Detection rate of bacteria in blood using in situ hybridization method | — |
Countries
Japan
Contacts
Public ContactHiroshi Saito
Aichi Cancer Center Aichi Hospital Department of Respiratory Medicine
Outcome results
None listed