Clinical Trials Logo
  1. Home
  2. Diarrhea
  3. NCT01371656

Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation

Diarrhea Clinical Trial

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)

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01371656
Study type Interventional
Source Children's Oncology Group
Contact
Status Completed
Phase Phase 3
Start date September 2011
Completion date June 2017
View Details
See also
  Status Clinical Trial Phase
Completed NCT06283784 - Study To Evaluate The Efficacy of a Proprietary Mix of Live Probiotics In The Prophylaxis Of Diarrhea In Adult Patients N/A
Recruiting NCT03851835 - Multi-DOSE Oral Ondansetron for Pediatric Acute GastroEnteritis Phase 3
Completed NCT04003181 - The Pathogenesis of Chronic Diarrhoea After Treatment for Cancer in Cecum and the Ascending Colon N/A
Completed NCT03596827 - The Protective Immune Response to Attenuated Enterotoxigenic Escherichia Coli Infection N/A
Recruiting NCT05372068 - Cement flooRs AnD chiLd hEalth (CRADLE) N/A
Completed NCT03972618 - Evaluation of the Efficacy of Sawyer Point One Filters in Schools and Homes in the Dominican Republic N/A
Completed NCT05207618 - Utility of the Administration of Chesnut and Quebracho Extract for Irritable Bowel Syndrome Diarrhea Predominant N/A
Not yet recruiting NCT05052489 - Registry and Clinical Observation of Children With Diarrhoeal Disease
Completed NCT02428647 - Lao Zinc Study: Effects of Two Forms of Daily Preventive Zinc Versus Therapeutic Zinc Supplementation N/A
Completed NCT02541695 - Characterization of Resistance Against Live-attenuated Diarrhoeagenic E. Coli N/A
Completed NCT02197780 - Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD N/A
Completed NCT01739231 - Live Attenuated ETEC Vaccine ACE527 With and Without dmLT Adjuvant in Adults Phase 1/Phase 2
Completed NCT01968408 - Lactobacillus Reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children Phase 3
Terminated NCT01048567 - Efficacy and Safety of Lactobacillus Acidophilus/Rhamnosus Combination for the Prevention of Antibiotic-associated Diarrhea in the Elderly Phase 2
Not yet recruiting NCT01382199 - Recombinant Human Lactoferrin Administered Orally for the Prevention of Antibiotic Associated Diarrhea in Adult Patients Phase 3
Terminated NCT01472211 - Water-based Zinc Intervention Trial in Zinc Deficient Children Phase 0
Completed NCT01438645 - ScopeGuide-assisted Colonoscopy Versus Conventional Colonoscopy N/A
Completed NCT00914225 - Effect of Bednets and a Water Purification Device on HIV Disease Progression Among ART naïve Patients in Kenya N/A
Completed NCT00760851 - Yogurt Study in Children 2-4 Years Old Attending Daycare Phase 3
Completed NCT00198796 - Dose-finding Study of WS6788A, DS37-4 and H10407 Enterotoxigenic Escherichia Coli (ETEC) Challenge Strains Phase 1