Spots Global Cancer Trial Database for Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation
Official Title: A Randomized Trial of Levofloxacin to Prevent Bacteremia in Children Being Treated for Acute Leukemia (AL) or Undergoing Hematopoietic Stem Cell Transplantation (HSCT)
Study ID: NCT01371656
Conditions
Interventions
Study Description
Brief 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.
Keywords
Eligibility
Minimum Age: 6 Months
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arkansas Children's Hospital, Little Rock, Arkansas, United States
Southern California Permanente Medical Group, Downey, California, United States
City of Hope Medical Center, Duarte, California, United States
Loma Linda University Medical Center, Loma Linda, California, United States
Miller Children's Hospital, Long Beach, California, United States
Children's Hospital Los Angeles, Los Angeles, California, United States
Cedars-Sinai Medical Center, Los Angeles, California, United States
Rady Children's Hospital - San Diego, San Diego, California, United States
University of California San Francisco Medical Center-Parnassus, San Francisco, California, United States
Connecticut Children's Medical Center, Hartford, Connecticut, United States
Alfred I duPont Hospital for Children, Wilmington, Delaware, United States
Children's National Medical Center, Washington, District of Columbia, United States
Lombardi Comprehensive Cancer Center at Georgetown University, Washington, District of Columbia, United States
Golisano Children's Hospital of Southwest Florida, Fort Myers, Florida, United States
Nemours Children's Clinic - Jacksonville, Jacksonville, Florida, United States
Nemours Children's Hospital, Orlando, Florida, United States
Nemours Children's Clinic - Pensacola, Pensacola, Florida, United States
All Children's Hospital, Saint Petersburg, Florida, United States
Saint Mary's Hospital, West Palm Beach, Florida, United States
Children's Healthcare of Atlanta - Egleston, Atlanta, Georgia, United States
Georgia Regents University, Augusta, Georgia, United States
University of Illinois, Chicago, Illinois, United States
Advocate Children's Hospital-Oak Lawn, Oak Lawn, Illinois, United States
Riley Hospital for Children, Indianapolis, Indiana, United States
Saint Vincent Hospital and Health Services, Indianapolis, Indiana, United States
Blank Children's Hospital, Des Moines, Iowa, United States
University of Kentucky, Lexington, Kentucky, United States
Kosair Children's Hospital, Louisville, Kentucky, United States
Tulane University Health Sciences Center, New Orleans, Louisiana, United States
Children's Hospital-Main Campus, New Orleans, Louisiana, United States
Ochsner Medical Center, New Orleans, Louisiana, United States
Sinai Hospital of Baltimore, Baltimore, Maryland, United States
Floating Hospital for Children at Tufts Medical Center, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
C S Mott Children's Hospital, Ann Arbor, Michigan, United States
Helen DeVos Children's Hospital at Spectrum Health, Grand Rapids, Michigan, United States
Michigan State University - Breslin Cancer Center, Lansing, Michigan, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis, Minneapolis, Minnesota, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Saint John's Mercy Medical Center, Saint Louis, Missouri, United States
Children's Hospital and Medical Center of Omaha, Omaha, Nebraska, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Nevada Cancer Research Foundation CCOP, Las Vegas, Nevada, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Saint Peter's University Hospital, New Brunswick, New Jersey, United States
UMDNJ - Robert Wood Johnson University Hospital, New Brunswick, New Jersey, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
Montefiore Medical Center, Bronx, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
New York University Langone Medical Center, New York, New York, United States
Columbia University Medical Center, New York, New York, United States
University of Rochester, Rochester, New York, United States
Ny Cancer%, Valhalla, New York, United States
Mission Hospital-Memorial Campus, Asheville, North Carolina, United States
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
Children's Hospital Medical Center of Akron, Akron, Ohio, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Nationwide Children's Hospital, Columbus, Ohio, United States
The Children's Medical Center of Dayton, Dayton, Ohio, United States
The Toledo Hospital/Toledo Children's Hospital, Toledo, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Lehigh Valley Hospital - Muhlenberg, Bethlehem, Pennsylvania, United States
Geisinger Medical Center, Danville, Pennsylvania, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States
Palmetto Health Richland, Columbia, South Carolina, United States
Sanford USD Medical Center - Sioux Falls, Sioux Falls, South Dakota, United States
Driscoll Children's Hospital, Corpus Christi, Texas, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
Brooke Army Medical Center, Fort Sam Houston, Texas, United States
Cook Children's Medical Center, Fort Worth, Texas, United States
Baylor College of Medicine, Houston, Texas, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Methodist Children's Hospital of South Texas, San Antonio, Texas, United States
Childrens Hospital-King's Daughters, Norfolk, Virginia, United States
Providence Sacred Heart Medical Center and Children's Hospital, Spokane, Washington, United States
Madigan Army Medical Center, Tacoma, Washington, United States
Marshfield Clinic, Marshfield, Wisconsin, United States
CancerCare Manitoba, Winnipeg, Manitoba, Canada
Janeway Child Health Centre, Saint John's, Newfoundland and Labrador, Canada
McMaster Children's Hospital at Hamilton Health Sciences, Hamilton, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital, Kingston, Ontario, Canada
Hospital for Sick Children, Toronto, Ontario, Canada
The Montreal Children's Hospital of the MUHC, Montreal, Quebec, Canada
Contact Details
Name: Sarah Alexander, MD
Affiliation: Children's Oncology Group
Role: PRINCIPAL_INVESTIGATOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
