A Randomized Trial of Levofloxacin to Prevent Bacteremia in Children Being Treated for Acute Leukemia (AL) or Undergoing Hematopoietic Stem Cell Transplantation (HSCT)
- 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
- 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 Escherichia coli, Klebsiella pneumoniae,
Pseudomonas aeruginosa, and Streptococcus mitis.
- 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.
- To determine whether levofloxacin prophylaxis reduces the incidence of fever with
neutropenia, severe infection, and death from bacterial infection.
- To assess the safety of levofloxacin prophylaxis, with specific attention to
musculoskeletal disorders including tendinopathy and tendon rupture.
- 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: This is a multicenter study. Patients are stratified according to diagnosis (de
novo acute myeloid leukemia [AML] vs secondary AML vs relapsed AML vs relapsed acute
lymphoblastic leukemia [ALL]), and therapy (undergoing autologous HSCT vs undergoing
allogeneic HSCT). Patients are randomized to 1 of 2 treatment groups.
- Arm I: Patients receive levofloxacin orally (PO) or IV over 60-90 minutes once or twice
daily beginning on day 1 during 2 consecutive courses of chemotherapy or beginning on
day -2 during hematopoietic stem cell transplantation (HSCT) and continuing until blood
- Arm II: Patients receive established standard of care and receive chemotherapy or HSCT
as patients in arm 1.
Musculoskeletal assessment is conducted at baseline and at 2 and 12 months.
Patients may undergo perirectal or stool swab collection for ancillary studies.
After completion of study therapy, patients are followed up for 1 year.
Allocation: Randomized, Masking: Single Blind, Primary Purpose: Supportive Care
Occurrence of at least 1 episode of true bacteremia during the study timeframe of 2 courses of chemotherapy or 1 transplant procedure among AL and HSCT subjects, respectively
Sarah Alexander, MD
The Hospital for Sick Children
|Roswell Park Cancer Institute||Buffalo, New York 14263|
|Children's Hospital of Philadelphia||Philadelphia, Pennsylvania 19104|
|Sanford Cancer Center at Sanford USD Medical Center||Sioux Falls, South Dakota 57117-5039|
|Children's National Medical Center||Washington, District of Columbia 20010-2970|
|Nemours Children's Clinic||Jacksonville, Florida 32207|
|All Children's Hospital||St. Petersburg, Florida 33701|
|Children's Hospital of New Orleans||New Orleans, Louisiana 70118|
|City of Hope Comprehensive Cancer Center||Duarte, California 91010|
|Southern California Permanente Medical Group||Downey, California 90242|
|Kosair Children's Hospital||Louisville, Kentucky 40202-3830|
|Children's Hospital of the King's Daughters||Norfolk, Virginia 23507|
|Arkansas Cancer Research Center at University of Arkansas for Medical Sciences||Little Rock, Arkansas 72205|
|Loma Linda University Cancer Institute at Loma Linda University Medical Center||Loma Linda, California 92354|
|Lee Cancer Care of Lee Memorial Health System||Fort Myers, Florida 33901|
|Nemours Children's Clinic - Orlando||Orlando, Florida 32806|
|St. Vincent Indianapolis Hospital||Indianapolis, Indiana 46260|
|Blank Children's Hospital||Des Moines, Iowa 50309|
|Alvin and Lois Lapidus Cancer Institute at Sinai Hospital||Baltimore, Maryland 21215|
|Breslin Cancer Center at Ingham Regional Medical Center||Lansing, Michigan 48910|
|Hackensack University Medical Center Cancer Center||Hackensack, New Jersey 07601|
|Albert Einstein Cancer Center at Albert Einstein College of Medicine||Bronx, New York 10461|
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|
|Methodist Children's Hospital of South Texas||San Antonio, Texas 78229-3993|
|David C. Pratt Cancer Center at St. John's Mercy||St. Louis, Missouri 63141|
|Greenebaum Cancer Center at University of Maryland Medical Center||Baltimore, Maryland 21201|
|Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center||Los Angeles, California 90048-1865|
|Rady Children's Hospital - San Diego||San Diego, California 92123-4282|
|UCSF Helen Diller Family Comprehensive Cancer Center||San Francisco, California 94115|
|Alfred I. duPont Hospital for Children||Wilmington, Delaware 19803|
|AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus||Atlanta, Georgia 30322|
|MBCCOP - Medical College of Georgia Cancer Center||Augusta, Georgia 30912-3730|
|University of Illinois Cancer Center||Chicago, Illinois 60612-7243|
|Keyser Family Cancer Center at Advocate Hope Children's Hospital||Oak Lawn, Illinois 60453|
|Lucille P. Markey Cancer Center at University of Kentucky||Lexington, Kentucky 40536-0093|
|Tulane Cancer Center Office of Clinical Research||Alexandria, Louisiana 71315-3198|
|Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|CCOP - Nevada Cancer Research Foundation||Las Vegas, Nevada 89109-2306|
|University of New Mexico Cancer Center||Albuquerque, New Mexico 87131-5636|
|Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center||New York, New York 10032|
|Akron Children's Hospital||Akron, Ohio 44308-1062|
|Dayton Children's - Dayton||Dayton, Ohio 45404-1815|
|Oklahoma University Cancer Institute||Oklahoma City, Oklahoma 73104|
|Children's Hospital of Pittsburgh of UPMC||Pittsburgh, Pennsylvania 15213|
|Madigan Army Medical Center - Tacoma||Tacoma, Washington 98431|
|Riley's Children Cancer Center at Riley Hospital for Children||Indianapolis, Indiana 46202-5225|
|Connecticut Children's Medical Center||Hartford, Connecticut 06106|
|Nemours Children's Clinic - Pensacola||Pensacola, Florida 32504|