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

NCT ID: NCT00195533

Last Updated: 2009-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

801 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-07-31

Study Completion Date

2005-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hematological Malignancy Leukemia Myelodysplasia Lymphoma Myeloma Stem Cell Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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piperacillin-tazobactam

Intervention Type DRUG

glycopeptide

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

UNKNOWN

Sponsor Role collaborator

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Spain, [email protected]

Locations

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A Coruña, , Spain

Site Status

Alcalá de Henares, , Spain

Site Status

Alzira, , Spain

Site Status

Barcelona, , Spain

Site Status

Castellon, , Spain

Site Status

Madrid, , Spain

Site Status

Salamanca, , Spain

Site Status

Santa Cruz de Tenerife, , Spain

Site Status

Tarragona, , Spain

Site Status

Valencia, , Spain

Site Status

Valladolid, , Spain

Site Status

Zaragoza, , Spain

Site Status

Countries

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Spain

Other Identifiers

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100943

Identifier Type: -

Identifier Source: org_study_id

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