Study Comparing Piperacillin-Tazobactam Versus Piperacillin-Tazobactam Plus Glycopeptide in Neutropenic Patients
Information source: Wyeth
Information obtained from ClinicalTrials.gov on October 19, 2009
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: Recruiting
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
Trial Manager, Principal Investigator, Affiliation: For Spain, infomed@wyeth.com
Overall contact:
Trial Manager, Email: clintrialparticipation@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: Natural History, Longitudinal, Defined Population, Prospective Study
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
Trial Manager, Email: clintrialparticipation@wyeth.com
Coruña, Spain; Recruiting
Barcelona, Spain; Recruiting
Alcalá de Henares, Spain; Recruiting
Alcira, Spain; Recruiting
Castellon, Spain; Recruiting
Madrid, Spain; Recruiting
Salamanca, Spain; Recruiting
Tarragona, Spain; Recruiting
Tenerife, Spain; Recruiting
Valencia, Spain; Recruiting
Valladolid, Spain; Recruiting
Zaragoza, Spain; Recruiting
Additional Information
Starting date: July 2001
Last updated: May 17, 2006
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