A Trial of Fosfomycin vs Ciprofloxacin for Febrile Neutropenia

NCT05311254 | Unknown Phase 3

• 2 other identifiers: FOVOCIP2021-000354-25
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief 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

Febrile Neutropenia

Outcome Measures

Primary Outcomes (1)

• Febrile neutropenia of infectious origin

  Febrile neutropenia that requires antibacterial treatment.

  Immediately after the intervention until febrile neutropenia develops, neutrophil count >0,5x109/L up to 60 days maximum

Secondary Outcomes (7)

• Documented infections

  Immediately after the intervention until febrile neutropenia develops, neutrophil count >0,5x109/L up to 60 days maximum

• Use of broad spectrum antibiotics

  Immediately after the intervention until febrile neutropenia develops, neutrophil count >0,5x109/L up to 60 days maximum

• Overall survival

  Time from the day of randomization to the date of death, whatever the cause of death, up to 12 weeks.

• Drug related adverse events

  Immediately after the intervention until febrile neutropenia develops, neutrophil count >0,5x109/L up to 60 days maximum

• Evolution of resistome

  Immediately after the intervention until febrile neutropenia develops, neutrophil count >0,5x109/L up to 60 days maximum

Study Arms (2)

Fosfomycin

EXPERIMENTAL

Drug: Fosfomycin: oral capsules containing 700 mg of calcium fosfomycin, equivalent to 500 mg of active drug.

Drug: Fosfomycin Calcium

Ciprofloxacin

ACTIVE COMPARATOR

Oral ciprofloxacin, tablets containing 500 mg of active drug.

Drug: Fosfomycin Calcium

Interventions

Fosfomycin Calcium DRUG

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

Ciprofloxacin; Fosfomycin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who are able to understand study procedures, comply with them, and provide written informed consent before any study-specific procedure.
• Adult subjects ≥ 18 years of age with acute leukemia diagnosis who are going to receive their first intensive chemotherapy cycle or adult subjects ≥ 18 years of age who are candidates to receive a first stem cell transplant.
• Expected neutropenia 100x109/L lasting at least seven days. In case of expected neutropenia range 100-500x109/L lasting seven days or more, at least one of the following risk factors for infection must be present:
• Performance status (Eastern Cooperative Oncology Group, ECOG) ≥2.
• Expected mucositis grade 3-4.
• Age ≥65 years.
• Comorbidity Index (HCTI) ≥3.
• Serum albumin\< 35 g/L.
• Total dose of etoposide \> 500 mg/m2
• Total dose of cytarabine \> 1 g/m2
• Active or refractory neoplasia at the moment of stem cell transplant.
• Performance status (Eastern Cooperative Oncology Group, ECOG) of 0 to 3.
• Adequate organ function defined as:
• Liver: bilirubin, alkaline phosphatase, or SGOT \< 3 times the upper normal limit (unless it is attributable to tumor activity).
• Renal : creatinine ≤ 250 μmol/l (2.5 mg/dL) (unless it is attributable to AML activity).

You may not qualify if:

• Hypersensitivity to fluoroquinolones or fosfomycin.
• Treatment with broad spectrum antimicrobial therapy within 4 weeks of first study treatment.
• Prior Intensive chemotherapy or stem cell transplant. Treatment with hydroxyurea or corticosteroids used to control white blood cell counts are permitted.
• Fever of infectious origin or documented infection within 4 weeks of first study treatment.
• Subjects that have participated previously in this study

Sponsors & Collaborators

• Fundación para la Investigación Biosanitaria del Principado de Asturias: lead
• Instituto de Investigación Marqués de Valdecilla: collaborator
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Instituto de Investigación Sanitaria del Principado de Asturias

Oviedo, Principality of Asturias, 33011, Spain

RECRUITING

Related Publications (1)

• Moreno AF, Lavin-Alconero L, de Ugarriza PL, Blanco LS, Hernandez SC, Burgues JMB, de Miguel MI, Huerta AJG, Zarzuela MP, Boluda B, Humala K, Calabuig ML, Amigo ML, Casas MC, Del Mar Garcia-Saiz M, Verdugo AF, Dominguez JF, Bernal T. FOVOCIP study: a multicenter randomized trial of fosfomycin versus ciprofloxacin for febrile neutropenia in hematologic patients-efficacy and microbiologic safety. Trials. 2023 Oct 27;24(1):694. doi: 10.1186/s13063-023-07702-5.

  PMID: 37891616 DERIVED

MeSH Terms

Conditions

Febrile Neutropenia

Condition Hierarchy (Ancestors)

Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Study Officials

• Teresa Bernal, MD PHD

  Hospital Universitario Central Asturias

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Teresa Bernal, MD PHD

CONTACT

+34 985108000; bernalmaria@uniovi.es

Javier Fernandez Dominguez, BD

CONTACT

+34985108000; javifdom@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Multicenter, randomized, prospective, open-label

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: April 5, 2022
• Study Start: March 14, 2022
• Primary Completion: March 14, 2024
• Study Completion: March 14, 2024
• Last Updated: September 14, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)