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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


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)


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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