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

This study has been completed.

First Received on September 13, 2005. Last Updated on November 13, 2009 History of Changes

Sponsor:	Wyeth is now a wholly owned subsidiary of Pfizer
Collaborator:	PETHEMA (Program for the Study and Treatment of Haematological Malignances)
Information provided by:	Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:	NCT00195533

Purpose

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.

Condition	Intervention	Phase
Hematological Malignancy Leukemia Myelodysplasia Lymphoma Myeloma Stem Cell Transplantation	Drug: piperacillin-tazobactam Drug: glycopeptide	Phase IV

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
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.

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Fever Leukemia Lymphoma Multiple Myeloma Myelodysplastic Syndromes

Drug Information available for: Piperacillin sodium Piperacillin Tazobactam Zosyn

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:

- 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) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Safety evaluation:during the empirical therapy

Secondary Outcome Measures:

Microbiological evaluation:at the completion of the therapeutic trial (overall evaluation) [ Time Frame: 3 Months ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Whole blood

Enrollment:	801
Study Start Date:	July 2001
Study Completion Date:	March 2005
Primary Completion Date:	March 2005 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Hematology units

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00195533

Locations

Spain

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

Sponsors and Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

PETHEMA (Program for the Study and Treatment of Haematological Malignances)

Investigators

Study Director:	Medical Monitor	Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:	Trial Manager	For Spain, infomed@wyeth.com

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00195533 History of Changes
Other Study ID Numbers:	100943
Study First Received:	September 13, 2005
Last Updated:	November 13, 2009
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Leukemia
Lymphoma
Myeloma

Additional relevant MeSH terms:

Neoplasms
Leukemia
Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Myelodysplastic Syndromes
Preleukemia
Hematologic Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases

Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Precancerous Conditions
Neoplasms by Site
Piperacillin
Penicillanic Acid
Piperacillin-tazobactam combination product
Tazobactam
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012