Study Comparing Piperacillin-tazobactam Versus Piperacillin-tazobactam Plus Glycopeptide in Neutropenic Patients
Information source: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hematological Malignancy; Leukemia; Myelodysplasia; Lymphoma; Myeloma; Stem Cell Transplantation
Intervention: piperacillin-tazobactam (Drug); glycopeptide (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Wyeth is now a wholly owned subsidiary of Pfizer Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
Trial Manager, Principal Investigator, Affiliation: For Spain, infomed@wyeth.com
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.
Clinical Details
Official title: 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.
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: - 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)- Safety evaluation:during the empirical therapy
Secondary outcome: Microbiological evaluation:at the completion of the therapeutic trial (overall evaluation)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Alcalá de Henares, Spain
Alcira, Spain
Barcelona, Spain
Castellon, Spain
Coruña, Spain
Madrid, Spain
Salamanca, Spain
Tarragona, Spain
Tenerife, Spain
Valencia, Spain
Valladolid, Spain
Zaragoza, Spain
Additional Information
Starting date: July 2001
Last updated: November 13, 2009
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