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| Sponsors and Collaborators: |
Wyeth PETHEMA (Program for the Study and Treatment of Haematological Malignances) |
|---|---|
| Information provided by: | Wyeth |
| 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: | Natural History, Longitudinal, Defined Population, Prospective Study |
| 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. |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Trial Manager | clintrialparticipation@wyeth.com |
| Spain | |
| Recruiting | |
| Coruña, Spain | |
| Recruiting | |
| Barcelona, Spain | |
| Recruiting | |
| Alcalá de Henares, Spain | |
| Recruiting | |
| Alcira, Spain | |
| Recruiting | |
| Castellon, Spain | |
| Recruiting | |
| Madrid, Spain | |
| Recruiting | |
| Zaragoza, Spain | |
| Recruiting | |
| Tarragona, Spain | |
| Recruiting | |
| Tenerife, Spain | |
| Recruiting | |
| Valencia, Spain | |
| Recruiting | |
| Valladolid, Spain | |
| Recruiting | |
| Salamanca, Spain | |
| Study Director: | Medical Monitor | Wyeth |
| Principal Investigator: | Trial Manager | For Spain, infomed@wyeth.com |
More Information
| Study ID Numbers: | 100943 |
| Study First Received: | September 13, 2005 |
| Last Updated: | May 17, 2006 |
| ClinicalTrials.gov Identifier: | NCT00195533 History of Changes |
| Health Authority: | Spain: Spanish Agency of Medicines |
|
Leukemia Lymphoma Myeloma |
|
Immunoproliferative Disorders Precancerous Conditions Hematologic Neoplasms Hematologic Diseases Myelodysplastic Syndromes Tazobactam Piperacillin-tazobactam combination product Multiple Myeloma Fever Anti-Bacterial Agents |
Leukemia Lymphatic Diseases Preleukemia Penicillanic Acid Piperacillin Lymphoproliferative Disorders Bone Marrow Diseases Lymphoma Neoplasms, Plasma Cell |
|
Anti-Infective Agents Hematologic Neoplasms Precancerous Conditions Molecular Mechanisms of Pharmacological Action Piperacillin-tazobactam combination product Leukemia Anti-Bacterial Agents Preleukemia Neoplasms by Site Therapeutic Uses Lymphoma Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Hematologic Diseases Myelodysplastic Syndromes Tazobactam Enzyme Inhibitors Pharmacologic Actions Lymphatic Diseases Neoplasms Penicillanic Acid Piperacillin Bone Marrow Diseases Lymphoproliferative Disorders |
