Clinical trial for the treatment of febrile neutropenia in hematologic patients with antibiotics: fosfomycin versus ciprofloxacin.

Phase 1

• Conditions: Post-chemotherapy neutropenia with high risk of developing infection in patients with acute leukemia undergoing induction, autologous or allogeneic hematopoietic stem cell transplantation.; MedDRA version: 21.0Level: LLTClassification code 10000835Term: Acute leukemiaSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10076734Term: Chemotherapy induced neutropeniaSystem Organ Class: 100000004851; MedDRA version: 22.0Level: LLTClassification code 10067862Term: Allogeneic stem cell transplantationSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2021-000354-25-ES
• Lead Sponsor: FINBA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-25
• Last Update Posted: 15 November 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

Subjects must meet all of the following inclusion criteria:
1. Subjects must be able to understand the study procedures, comply with them, and give written informed consent prior to any specific study procedure.
2. Adult subjects = 18 years of age with a diagnosis of acute leukemia who are to receive their first course of chemotherapy or adult subjects = 18 years of age who are candidates for a first stem cell transplant.
3. Expected neutropenia of 100x109/L lasting at least seven days. In the case of an expected range of 100-500x109/L neutropenia lasting seven days or longer, at least one of the following risk factors for infection must be present:
a. Performance status (Eastern Cooperative Oncology Group, ECOG) =2.
b. Expected grade 3-4 mucositis.
c. Age =65 years.
d. Comorbidity index (HCTI) =3.
e. Serum albumin< 35 g/L.
f. Total dose of etoposide > 500 mg/m2.
g. Total dose of cytarabine > 1 g/m2.
h. Active or refractory neoplasia at the time of stem cell transplantation.
4. Performance status (Eastern Cooperative Oncology Group, ECOG) of 0 to 3.
5. Adequate organ function defined as:
- Liver : bilirubin, alkaline phosphatase or SGOT < 3 times the upper limit of normal (unless attributable to tumor activity).
- Renal : creatinine = 250 µmol/l (2.5 mg/dL) (unless attributable to AML activity).
6. Life expectancy greater than 3 months.
7. Women of childbearing age should not be pregnant or breastfeeding and should have a negative pregnancy test at the time of screening. Women of childbearing age and men with female partners of childbearing age must agree to practice 2 highly effective contraceptive measures and must agree not to become pregnant or father a child while receiving any study therapy and for at least 3 months after completion of treatment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 78
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 78

Exclusion Criteria

Patients who meet any of the following exclusion criteria cannot be included in this study:
1. Hypersensitivity to fluoroquinolones or fosfomycin.
2. Treatment with broad-spectrum antimicrobial therapy within 4 weeks of the first study treatment.
3. Prior intensive chemotherapy or stem cell transplantation. Treatment with hydroxyurea or corticosteroids used to control white blood cell count is allowed.
4. Fever of infectious origin or documented infection within 4 weeks of first study treatment.
5. Presence of any serious psychiatric illness or physical condition that, in the judgment of the physicians, contraindicates the patient's inclusion in the clinical trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified