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Study Comparing Piperacillin-Tazobactam Versus Piperacillin-Tazobactam Plus Glycopeptide in Neutropenic Patients

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase IV

Supportive care

Active

18 and over

Pharmaceutical / Industry

100943
NCT00195533

Trial Description

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.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Wyeth Research

Program for the Study and Treatment of Hematological Malignancies

Medical Monitor

Study Director

Trial Manager

Principal Investigator

Trial Manager
		Email: clintrialparticipation@wyeth.com

Trial Sites

Spain

Alcalá de Henares

Study Site

Alcira

Study Site

Barcelona

Study Site

Castellon

Study Site

Coruña

Study Site

Madrid

Study Site

Salamanca

Study Site

Tarragona

Study Site

Tenerife

Study Site

Valencia

Study Site

Valladolid

Study Site

Zaragoza

Study Site

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00195533
Information obtained from ClinicalTrials.gov on May 27, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.