Monotherapy With Piperacillin-tazobactam Versus Combination Therapy With Piperacillin-tazobactam Plus Glycopeptide as an Initial Empiric Therapy for Fever in Neutropenic Patients. An Observational Prospective Study.
Phase 4
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Hematological Malignancy, Leukemia, Myelodysplasia, Lymphoma, Myeloma, Stem Cell Transplantation
Both
Hematological Malignancy, Leukemia, Myelodysplasia, Lymphoma, Myeloma, Stem Cell Transplantation
Trial Information
Monotherapy With Piperacillin-tazobactam Versus Combination Therapy With Piperacillin-tazobactam Plus Glycopeptide as an Initial Empiric Therapy for Fever in Neutropenic Patients. An Observational Prospective Study.
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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
- 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)
Outcome Time Frame:
3 months
Safety Issue:
No
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Wyeth is now a wholly owned subsidiary of Pfizer
Authority:
Spain: Spanish Agency of Medicines
Study ID:
100943
NCT ID:
NCT00195533
Start Date:
July 2001
Completion Date:
March 2005
Related Keywords:
- Hematological Malignancy
- Leukemia
- Myelodysplasia
- Lymphoma
- Myeloma
- Stem Cell Transplantation
- Leukemia
- Lymphoma
- Myeloma
- Neoplasms
- Leukemia
- Lymphoma
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Myelodysplastic Syndromes
- Preleukemia
- Hematologic Neoplasms
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