Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation
|ClinicalTrials.gov Identifier: NCT01371656|
Recruitment Status : Completed
First Posted : June 13, 2011
Last Update Posted : February 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: levofloxacin||Phase 3|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||740 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|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)|
|Actual Study Start Date :||September 2011|
|Primary Completion Date :||June 2017|
|Study Completion Date :||June 2017|
Experimental: Arm I (levofloxacin)
Patients receive levofloxacin PO or IV over 60-90 minutes once or twice daily beginning on day 3 during 2 consecutive courses of chemotherapy or beginning on day -2 during HSCT and continuing until blood counts recover.
Given PO or IV
No Intervention: Arm II (standard of care)
Patients receive established standard of care and receive chemotherapy or HSCT as patients in Arm I.
- Occurrence of at least 1 episode of true bacteremia among AL and HSCT subjects, respectively [ Time Frame: Up to 60 days ]
- Susceptibility of E. coli, K. pneumoniae, and P. aeruginosa stool or peri-rectal swab isolates to cefepime, imipenem, and levofloxacin [ Time Frame: Up to 1 year ]
- Susceptibility of S. mitis peri-rectal swab isolates to cefepime, levofloxacin, and penicillin [ Time Frame: Up to 1 year ]
- Presence of carbapenem-resistant Enterobacteriaceae [ Time Frame: Up to 1 year ]
- Resistance patterns for the gastrointestinal isolates colonizing each patient [ Time Frame: Up to 1 year ]
- Resistance patterns of bacterial isolates from all sterile site cultures [ Time Frame: Up to 1 year ]
- Duration of parenteral antibiotic administration [ Time Frame: During 2 courses of chemotherapy or 1 transplantation procedure ]
- Incidence of febrile neutropenia [ Time Frame: Up to 1 year ]Graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0.
- Incidence of severe infection [ Time Frame: Up to 1 year ]Graded using the NCI CTCAE v. 4.0.
- Incidence of death from bacterial infection [ Time Frame: Up to 1 year ]Graded using the NCI CTCAE v. 4.0.
- Incidence of musculoskeletal adverse events [ Time Frame: Up to 1 year ]Graded using the NCI CTCAE v. 4.0.
- Incidence of tendinopathy (tendonitis and tendon rupture) [ Time Frame: Up to 1 year ]
- Incidence of CDAD, defined as a positive C. difficile toxin assay result and diarrhea, CTCAE version 4, grade 2 and higher [ Time Frame: Up to 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01371656
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|Principal Investigator:||Sarah Alexander, MD||Children's Oncology Group|