Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation
Condition: Acute Leukemias of Ambiguous Lineage; Bacterial Infection; Diarrhea; Fungal Infection; Musculoskeletal Complications; Neutropenia; Recurrent Childhood Acute Lymphoblastic Leukemia; Recurrent Childhood Acute Myeloid Leukemia; Secondary Acute Myeloid Leukemia; Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies
MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Mycoses; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Neutropenia; Recurrence; Diarrhea; Acute Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This randomized phase III trial studies how well levofloxacin works in preventing infection
      in young patients with acute leukemia receiving chemotherapy or undergoing stem cell
      transplant. Giving antibiotics may be effective in preventing or controlling early infection
      in patients receiving chemotherapy or undergoing stem cell transplant for acute leukemia. It
      is not yet known whether levofloxacin is effective in preventing infection.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To determine whether levofloxacin given prophylactically during periods of neutropenia to
      patients being treated with chemotherapy for acute leukemia (AL) or undergoing hematopoietic
      stem cell transplantation (HSCT) will decrease the incidence of bacteremia.

      SECONDARY OBJECTIVES:

      I. To determine the effect of prophylactic levofloxacin on resistance patterns of bacterial
      isolates from all sterile site cultures, and the evolution of antimicrobial resistance from
      peri-rectal swab isolates of Enterobacteriaceae, Escherichia coli, Klebsiella pneumoniae,
      Pseudomonas aeruginosa, and Streptococcus mitis.

      II. To determine the effect of levofloxacin prophylaxis on total number of days of antibiotic
      administration (prophylactic, empiric, and treatment) in children undergoing therapy for AL
      or HSCT.

      III. To determine whether levofloxacin prophylaxis reduces the incidence of fever with
      neutropenia, severe infection, and death from bacterial infection.

      IV. To assess the safety of levofloxacin prophylaxis, with specific attention to
      musculoskeletal disorders including tendinopathy and tendon rupture.

      V. To assess the impact of prophylactic levofloxacin on the incidence of Clostridium
      difficile-associated diarrhea (CDAD), and the incidence of microbiologically documented
      invasive fungal infections (IFI).

      OUTLINE: Patients are randomized to 1 of 2 treatment arms.

      ARM I: Patients receive levofloxacin orally (PO) or intravenously (IV) over 60-90 minutes
      once daily (QD) or twice daily (BID) beginning on day 3 during 2 consecutive courses of
      chemotherapy or beginning on day -2 during HSCT and continuing until blood counts recover.

      ARM II: Patients receive established standard of care and receive chemotherapy or HSCT as
      patients in Arm I.

      After completion of study therapy, patients are followed up for 1 year.
    

Intervention name(s): levofloxacin
Intervention type(s): Drug
Intervention description(s): Given PO or IV
Other intervention name(s): Levaquin; Quixin
Intervention MeSH terms: Levofloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Supportive Care