Neutropenic FeverPhase 4NCT07320534

Levofloxacin Prophylaxis to Prevent First Febrile Neutropenia in Pediatric ALL During Induction Phase

A Phase 4 study testing Levofloxacin in people with Neutropenic Fever and Acute Lymphoblastic Leukemia, run by Gadjah Mada University at 1 site in Indonesia.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 6 months to 18 years
Conditions the study is for: Neutropenic Fever, Acute Lymphoblastic Leukemia
What is being tested?: Levofloxacin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 49 participants
Where: 1 siteIndonesia
Study dates: 1 Jan 2026to 13 Sep 2026
Phase: Phase 4

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 months to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

All patients aged 1 to 18 years diagnosed with acute lymphoblastic leukemia (ALL).
Receiving induction phase 1A chemotherapy for ALL using the Indonesian National Childhood ALL Pilot Protocol 2024 Standard Risk; induction phases 1A and 1B chemotherapy using the Indonesian National Childhood ALL Pilot Protocol 2024 High Risk; or induction chemotherapy using the ACT4ALL Protocol 2025 at Dr. Sardjito Hospital.
No history of allergy to levofloxacin.
Parents/guardians provide written informed consent.

Who cannot join

Death before initiation of chemotherapy.
Patients with clinically or microbiologically confirmed infection within 72 hours prior to induction chemotherapy who require antibiotics for more than 5 days (to avoid antibiotic therapy as a confounding factor for antibiotic prophylaxis).

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

RSUP dr Sardjito
Sleman, DI Yogyakarta

Other trials in Indonesia

About this study

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

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.

Read the 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.

Conditions: Neutropenic Fever, Acute Lymphoblastic Leukemia
Being tested: Levofloxacin, Placebo
Keywords: Neutropenic Fever, Acute Lymphoblastic Leukemia, Levofloxacin
Medical subject headings: Febrile Neutropenia, Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LevofloxacinDrug
younger than 5 years received levofloxacin 10 mg/kg by mouth every 12 hours and patients 5 years and older received 10 mg/kg by mouth once daily (maximum 500 mg/dose)
PlaceboOther
Receiving oral placebo at the same dosage as the treatment group.

Study groups in NCT07320534
Study group	Role	What they receive
Group A: Levofloxacin	Experimental	Receiving oral levofloxacin as infection prophylaxis during the induction phase, with the following dosage: * Age < 5 years: 10 mg/kg PO every 12 hours (maximum 250 mg/dose) * Age ≥ 5 years: 10 mg/kg PO once daily (maximum 500 mg/day) Receives: Drug: Levofloxacin
Group B: Placebo	Placebo comparator	Receiving oral placebo at the same dosage as the treatment group. Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Median time to first febrile neutropenia
The number of participants with first febrile neutropenia and the median day of occurrence.
Measured: First febrile neutropenia up to day 63
Clinical Outcome
The number of participants who experienced fever, first febrile neutropenia, severe infection, organ-related infection, microbiologically confirmed infection, infection-related mortality
Measured: First febrile neutropenia up to day 63

Secondary outcomes (2)

Caused of mortality
The cause of mortality in the participants.
Measured: up to 12 weeks
Patients with positive cultures
The number of participants who were positive for bacteria or fungi, and the number of participants with antibiotic resistance (resistant to fluoroquinolones, carbapenems, or vancomycin).
Measured: up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202613 Sep 2026

First posted6 Jan 2026
Study start1 Jan 2026
Primary completion31 Aug 2026
Study completion13 Sep 2026

Why it stopped: Interim analysis showed no significant benefit of levofloxacin. Prolonged antibiotic use may increase adverse effects and resistance. Limited funding and the approaching end of the study period also supported early termination.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Neutropenic FeverStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 49 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07320534
Sponsor's protocol ID: KE/FK/1504/EC/2025
Status last verified: Sep 2026
First submitted: 24 Sep 2025
Last updated: 1 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Inform Consent Form

Publications

Alexander S, Fisher BT, Gaur AH, Dvorak CC, Villa Luna D, Dang H, Chen L, Green M, Nieder ML, Fisher B, Bailey LC, Wiernikowski J, Sung L; Children's Oncology Group. Effect of Levofloxacin Prophylaxis on Bacteremia in Children With Acute Leukemia or Undergoing Hematopoietic Stem Cell Transplantation: A Randomized Clinical Trial. JAMA. 2018 Sep 11;320(10):995-1004. doi: 10.1001/jama.2018.12512.
PubMed 30208456
Patel B, Noda A, Godbout E, Stevens M, Noda C. Levofloxacin for Antibacterial Prophylaxis in Pediatric Patients With Acute Myeloid Leukemia or Undergoing Hematopoietic Stem Cell Transplantation. J Pediatr Pharmacol Ther. 2020;25(7):629-635. doi: 10.5863/1551-6776-25.7.629.
PubMed 33041718

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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