Hematological Malignancy, Leukemia, Myelodysplasia, Lymphoma, Myeloma, Stem Cell Transplantation
Conditions
Keywords
Leukemia, Lymphoma, Myeloma
Brief summary
The aim of this study is to compare the efficacy and tolerance of piperacillin-tazobactam versus piperacillin-tazobactam plus glycopeptide as initial empiric antibiotic treatment for fever in neutropenic patients. Study of consecutive cohorts(2). First the patients will be included in the monotherapy branch until completing the predicted number of cases. When this happens, the Coordinating Center will communicate it to the participant centers and from then the patients will be included in the combined therapy.
Interventions
DRUGglycopeptide
Sponsors
PETHEMA (Program for the Study and Treatment of Haematological Malignances)
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with hematological malignancy or those who had undergone stem cell transplantation for neoplastic disease. * Fever (\>38ºC) * Neutropenia (absolute neutrophil count \< 500 or \< 1000 anticipated to fall below 500 cells within 24-48 hours).
Exclusion criteria
* Known allergy to any of the antibiotics used in this trial * A high probability of death within 48 hours
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Clinical efficacy evaluation:72 and 96 hours after the initiation of empirical therapy (early evaluation) and at the completion of the therapeutic trial (overall valuation) | 3 months |
| - Safety evaluation:during the empirical therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Microbiological evaluation:at the completion of the therapeutic trial (overall evaluation) | 3 Months |
Countries
Spain
Outcome results
None listed