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

Official record

Identifier

NCT07320534

Recruiting locations

country

Indonesia

Interventions studied

LevofloxacinPlacebo

Lead sponsor

Gadjah Mada University

Target enrolment

49 participants

Study type

INTERVENTIONAL

Phase

Phase 4

Status

Terminated

First posted

Jan 6, 2026

Last updated on the registry

Oct 1, 2026

Age

6 Months – 18 Years

Sex

ALL

Study contact

No public contact is listed on the official record.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Indexed under

Lymphoma