Study Comparing Piperacillin-tazobactam Versus Piperacillin-tazobactam Plus Glycopeptide in Neutropenic Patients
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.
1 other identifier
observational
801
1 country
12
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2001
Typical duration for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 19, 2005
CompletedNovember 16, 2009
November 1, 2009
3.7 years
September 13, 2005
November 13, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
- 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)
3 months
- Safety evaluation:during the empirical therapy
Secondary Outcomes (1)
Microbiological evaluation:at the completion of the therapeutic trial (overall evaluation)
3 Months
Interventions
Eligibility Criteria
Hematology units
You may qualify if:
- 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).
You may not qualify if:
- Known allergy to any of the antibiotics used in this trial
- A high probability of death within 48 hours
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Unknown Facility
A Coruña, Spain
Unknown Facility
Alcalá de Henares, Spain
Unknown Facility
Alzira, Spain
Unknown Facility
Barcelona, Spain
Unknown Facility
Castellon, Spain
Unknown Facility
Madrid, Spain
Unknown Facility
Salamanca, Spain
Unknown Facility
Santa Cruz de Tenerife, Spain
Unknown Facility
Tarragona, Spain
Unknown Facility
Valencia, Spain
Unknown Facility
Valladolid, Spain
Unknown Facility
Zaragoza, Spain
Biospecimen
Whole blood
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
- PRINCIPAL INVESTIGATOR
Trial Manager
For Spain, infomed@wyeth.com
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 19, 2005
Study Start
July 1, 2001
Primary Completion
March 1, 2005
Study Completion
March 1, 2005
Last Updated
November 16, 2009
Record last verified: 2009-11