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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00195533 |
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Date of registration:
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13/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study Comparing Piperacillin-tazobactam Versus Piperacillin-tazobactam Plus Glycopeptide in Neutropenic Patients
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Scientific title:
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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. |
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Date of first enrolment:
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July 2001 |
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Target sample size:
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801 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00195533 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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Countries of recruitment
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Spain
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Contacts
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Wyeth is now a wholly owned subsidiary of Pfizer |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Spain, infomed@wyeth.com |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Stem Cell Transplantation
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Hematological Malignancy
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Lymphoma
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Leukemia
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Myelodysplasia
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Myeloma
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Intervention(s)
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Drug: piperacillin-tazobactam
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Drug: glycopeptide
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Primary Outcome(s)
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- 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]
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- Safety evaluation:during the empirical therapy
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Secondary Outcome(s)
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Microbiological evaluation:at the completion of the therapeutic trial (overall evaluation)
[Time Frame: 3 Months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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