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)
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.
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. ;
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 | |
Completed |
NCT01438645 -
ScopeGuide-assisted Colonoscopy Versus Conventional Colonoscopy
|
N/A | |
Terminated |
NCT01472211 -
Water-based Zinc Intervention Trial in Zinc Deficient Children
|
Phase 0 | |
Not yet recruiting |
NCT01382199 -
Recombinant Human Lactoferrin Administered Orally for the Prevention of Antibiotic Associated Diarrhea in Adult Patients
|
Phase 3 | |
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 |