Patients who decided prophylactic administration of levofloxacin is necessary
Conditions
Interventions
administration of levofloxacin alone
co-administration of levofloxacin and magnesium oxide
Sponsors
Department of Pharmacy, Gunma Prefectural Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients receiving levofloxacin for prevention of bacterial infections 2) Signed informed consent 3) Age >= 20 and < 75 years 4) ECOG performance status: 0-3 5) Sufficient organ function of important organs Laboratory test results meet the following criteria (within 2 weeks before registration) a) Hemoglobin: >= 8.0 g/dL b) WBC: >= 3,000/mm3, <12,000/mm3 c) Neutrophil: >= 1,200/mm3 d) Platelet: >= 100,000/mm3 e) ALT, AST: =< 2.5 x the ULN for the reference lab f) Total bilirubin: =< 3 x the ULN for the reference lab g) Creatinine: =< the ULN for the reference lab
Exclusion criteria
Exclusion criteria: 1) Patients with a known allergy or hypersensitivity to any component of levofloxacin. 2) Patient who is unable to comply with dietary restriction*. *Patients taking prohibited medications and supplements high in metallic cations (e.g. sucralfate, iron pill, milk, yogurt, etc.) 3) Patients who have donated over 200 ml of blood within 2 weeks of therapy. 4) Female patients who are pregnant or breast feeding and women suspected of being pregnant. 5) Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of levofloxacin (e.g. ulcerative disease, malabsorption syndrome or small bowel resection). 6) Participation in a clinical trial within 12 weeks before registration. 7) Patients deemed ineligible by the attending physicians for various reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| area under the blood concentration-time curve (AUC) | — |
Countries
Japan
Contacts
Public ContactYukiyoshi Fujita
Gunma Prefectural Cancer Center Department of Pharmacy
Outcome results
None listed