MedTrace Logo

A Trial of Fosfomycin vs Ciprofloxacin for Febrile Neutropenia

NCT05311254 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2023-09-14

No results posted yet for this study

Summary

Randomized phase 3 trial to compare efficacy and safety of oral fosfomycin versus ciprofloxacin to prevent febrile neutropenia in patients with acute leukemia or recipients of hematopoietic stem cell transplant.

Conditions

Interventions

DRUG

Fosfomycin Calcium

Oral fosfomycin, three times daily, starting from the first day of induction chemotherapy or conditioning until absolute neutrophil count \>0,5x109/L.

Sponsors & Collaborators

  • Instituto de Investigación Marqués de Valdecilla

    collaborator OTHER

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • Fundación para la Investigación Biosanitaria del Principado de Asturias

    lead OTHER

Principal Investigators

  • Teresa Bernal, MD PHD · Hospital Universitario Central Asturias

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-14
Primary Completion
2024-03-14
Completion
2024-03-14

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05311254 on ClinicalTrials.gov