Acute Leukemia, Haematopoietic Stem Cell Transplantation
Conditions
Brief summary
Prophylaxis with fluoroquinolones in high-risk neutropenic patients is currently under scrutiny due to their toxicity and the potential of selecting multirresistant bacteria. In this setting, the search for an alternative prophylactic drug is a priority. The FOVOCIP study aimed to evaluate the efficacy and safety of fosfomycin compared to ciprofloxacin in this population. This was a multicentre, randomised, phase-3, non-inferiority, open-label trial performed in 11 centres in Spain. Adults diagnosed with acute leukaemia or recipients of a Haematopoietic Stem Cell Transplant were randomised to receive oral fosfomycin or oral ciprofloxacin as prophylaxis. The primary endpoint was rate of febrile neutropenia. Secondary endpoints included safety, including microbiological safety and gut microbiota changes .
Interventions
DRUGFosfomycin
5000 mg 3 times a day
DRUGciprofloxacin
500 mg twice a day
Sponsors
Fundación para la Investigación Biosanitaria del Principado de Asturias
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects must be able to understand the study procedures, comply with them, and provide written informed consent prior to any specific study procedures. 2. Adult subjects ≥ 18 years of age diagnosed with acute leukaemia who are scheduled to receive a first course of intensive chemotherapy. 3. Adult subjects ≥ 18 years of age who are candidates for a first allogeneic haematopoietic stem cell transplant with myeloablative conditioning or adult subjects ≥ 18 years of age who are candidates for a first allogeneic haematopoietic stem cell transplant with reduced-intensity conditioning or an autologous haematopoietic stem cell transplant, provided that at least one of the following risk factors for infection is present: 1. Functional status (Eastern Cooperative Oncology Group, ECOG) ≥2. 2. Expected grade 3-4 mucositis. 3. Age ≥65 years. 4. Comorbidity index (HCTI) ≥3. 5. Serum albumin \< 35 g/L. 6. Active or refractory neoplasia at the time of stem cell transplantation. 7. Total dose of etoposide \> 500 mg/m2. 8. Total dose of cytarabine \> 1 g/m2. 4. Functional status (Eastern Cooperative Oncology Group, ECOG) from 0 to 3. 5. Adequate organ function defined as: * Liver: bilirubin, alkaline phosphatase or SGOT \< 3 times the upper normal limit (unless attributable to tumour activity). * Renal: creatinine ≤ 250 μmol/l (2.5 mg/dL) (unless attributable to leukemic infiltration). 6. Life expectancy greater than 3 months. 7. Women of childbearing age must not be pregnant or breastfeeding and must have a negative pregnancy test at the time of screening. Women of childbearing age and men with female partners of childbearing age must commit to using two highly effective forms of contraception and must agree not to become pregnant or father a child while receiving any study therapy and for at least 3 months after completing treatment.
Exclusion criteria
Patients who meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Febrile neutropenia | The primary endpoint will be evaluated from the first day of chemotherapy until the absolute neutrophil count has reached >0.5x109/L, for a maximum of 60 days in case ANC >0.5x109/L is not reached. | Fever was defined as a single oral temperature of 38.3 °C or a temperature of 38 °C sustained over a 1-h period. If the patient was receiving any medication with a high probability of inducing fever or had been previously transfused, at least a positive culture or an infected site was required to be ascribed to infection. |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORTeresa Bernal, MD OHD
Universidad de Oviedo
Outcome results
None listed