Acute lymphoblastic leukemia
Conditions
Interventions
This is a two-arm, open-label, randomized controlled clinical trial. 200 Children ages 1 through 18 years (100 in the control group and 100 in the intervencion group), with newly-diagnosed Acute Lymph
(b) start of the next cycle of chemotherapy
(c) use of parenteral antibiotic therapy for any reason. Children from ages 1 to < 5 years will be given a dose of 10 mg/kg/dose of levofloxacin, twice a day
children older than 5 years will be prescribed 10 mg/kg/dose once a day, with a maximum dose of 750 mg a day. Levofloxacin will be administered orally but, if the oral route will not be tolerated, it
Sponsors
Hospital de Clínicas de Porto Alegre
Hospital de Clínicas de Porto Alegre
Eligibility
Age
1 Years to 19 Years
Inclusion criteria
Inclusion criteria: Patients with an initial diagnosis of Acute Lymphoblastic Leukemia; age from 1 year to 18 years.
Exclusion criteria
Exclusion criteria: Children with clinically or microbiologically documented infection before initiation of induction or with fever before induction therapy that required prolonged antibiotic therapy (more than 5 days); history of allergy to the use of quinolones; history of chronic arthritis being treated; patients who developed febrile neutropenia within the first 7 days of induction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| prevention of febrile neutropenia, defined by the presence of axillary body temperature greater than or equal to 37.8 oC in patients whose total neutrophil count was below 500/µL | — |
Secondary
| Measure | Time frame |
|---|---|
| Clostridoides difficile diarrhea, defined by the presence of diarrhea and identification of Clostridoides difficile in the stool or the presence of its toxins; colonization of carbapenemase-producing Enterobacteriaceae, monitoring performed by rectal swab at the time of admission to the hospital and at the end of the induction phase; Adverse events defined by World Health Organization criteria. | — |
Countries
Brazil
Contacts
Public ContactMauro Dufrayer
Hospital de Clínicas de Porto Alegre
Outcome results
None listed