Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 12:47 PM
Study NCT ID:
NCT07320534
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-08
First Post:
2025-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Levofloxacin Prophylaxis to Prevent First Febrile Neutropenia in Pediatric ALL During Induction Phase
Sponsor:
Gadjah Mada University
Organization:
Study Overview
Official Title:
The Effect of Levofloxacin Prophylaxis on the First Occurrence of Febrile Neutropenia During Induction Chemotherapy in Pediatric Patients With Acute Lymphoblastic Leukemia at Dr. Sardjito Hospital
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is To evaluate the benefit of levofloxacin prophylaxis in prolonging the median time to first febrile neutropenia in pediatric ALL patients during induction phase. It will also learn about the safety of levofloxacin during induction treatment.
The main questions it aims to answer are:
* Does levofloxacin prophylaxis increase the median time to the first febrile neutropenia episode compared to placebo?
* What are the rates of fever, severe infection, organ-related bacterial infection, and mortality in children receiving levofloxacin compared to placebo?
Researchers will compare oral levofloxacin to a placebo (a look-alike substance with no active drug) to see if levofloxacin is effective in preventing infection during induction chemotherapy.
Participants will:
* Be children aged 1 to 18 years with ALL undergoing induction chemotherapy.
* Be randomly assigned to receive either levofloxacin prophylaxis or placebo during the induction phase.
* Have regular checkups, physical exams, and laboratory tests during induction.
* Be monitored for fever, febrile neutropenia, severe infections, bacterial infections, and mortality.
* Stop prophylaxis once the first febrile neutropenia occurs or induction therapy is completed.
The main questions it aims to answer are:
* Does levofloxacin prophylaxis increase the median time to the first febrile neutropenia episode compared to placebo?
* What are the rates of fever, severe infection, organ-related bacterial infection, and mortality in children receiving levofloxacin compared to placebo?
Researchers will compare oral levofloxacin to a placebo (a look-alike substance with no active drug) to see if levofloxacin is effective in preventing infection during induction chemotherapy.
Participants will:
* Be children aged 1 to 18 years with ALL undergoing induction chemotherapy.
* Be randomly assigned to receive either levofloxacin prophylaxis or placebo during the induction phase.
* Have regular checkups, physical exams, and laboratory tests during induction.
* Be monitored for fever, febrile neutropenia, severe infections, bacterial infections, and mortality.
* Stop prophylaxis once the first febrile neutropenia occurs or induction therapy is completed.
Detailed Description:
Furthermore, this clinical trial aims to:
* To determine the incidence of fever during the induction phase in pediatric ALL patients receiving levofloxacin prophylaxis compared with placebo.
* To determine the incidence of febrile neutropenia during the induction phase in pediatric ALL patients receiving levofloxacin prophylaxis compared with placebo.
* To determine the incidence of severe infections during the induction phase in pediatric ALL patients receiving levofloxacin prophylaxis compared with placebo.
* To determine the number of organ-related bacterial infections, whether microbiologically confirmed or not, during the induction phase in pediatric ALL patients receiving levofloxacin prophylaxis compared with placebo.
* To determine the mortality rate during the induction phase in pediatric ALL patients receiving levofloxacin prophylaxis compared with placebo.
* To determine the incidence of fever during the induction phase in pediatric ALL patients receiving levofloxacin prophylaxis compared with placebo.
* To determine the incidence of febrile neutropenia during the induction phase in pediatric ALL patients receiving levofloxacin prophylaxis compared with placebo.
* To determine the incidence of severe infections during the induction phase in pediatric ALL patients receiving levofloxacin prophylaxis compared with placebo.
* To determine the number of organ-related bacterial infections, whether microbiologically confirmed or not, during the induction phase in pediatric ALL patients receiving levofloxacin prophylaxis compared with placebo.
* To determine the mortality rate during the induction phase in pediatric ALL patients receiving levofloxacin prophylaxis compared with placebo.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: